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(kht)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464422694/","id":464422694,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479595876/","id":479595876,"tags":[],"absolute_url":"/docket/70517657/47/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-18T12:00:54.689605-07:00","date_modified":"2026-05-29T03:19:40.647921-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":null,"pacer_doc_id":"119023939481","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Order on Motion to Withdraw as Attorney","acms_document_guid":""}],"date_created":"2026-05-18T12:00:54.640861-07:00","date_modified":"2026-05-29T03:19:40.621288-07:00","date_filed":"2026-05-18","time_filed":"14:57:04","entry_number":47,"recap_sequence_number":"2026-05-18.001","pacer_sequence_number":192,"description":"LETTER ORDER granting 44 Motion to Withdraw as Attorney. Attorney ZACHARY DENVER terminated. Signed by Magistrate Judge Tonianne J. Bongiovanni on 5/18/2026. (mj) (Entered: 05/18/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464255002/","id":464255002,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479422697/","id":479422697,"tags":[],"absolute_url":"/docket/70517657/46/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T14:05:22.163682-07:00","date_modified":"2026-05-29T03:19:40.548420-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"46","attachment_number":null,"pacer_doc_id":"119023935117","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Reply Brief to Opposition to Motion","acms_document_guid":""}],"date_created":"2026-05-15T14:05:22.101774-07:00","date_modified":"2026-05-29T03:19:40.522088-07:00","date_filed":"2026-05-15","time_filed":"16:36:47","entry_number":46,"recap_sequence_number":"2026-05-15.003","pacer_sequence_number":186,"description":"REPLY BRIEF to Opposition to Motion filed by AARON ONDREY, ROCKET PHARMACEUTICALS, INC., GAURAV SHAH re 40 MOTION to Dismiss (Attachments: # 1 Certificate of Service for Defendants' Reply IFS of Motion to Dismiss the Consolidated Amended Complaint)(RUBINSTEIN, BENJAMIN) (Entered: 05/15/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464254837/","id":464254837,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479422532/","id":479422532,"tags":[],"absolute_url":"","date_created":"2026-05-15T14:05:06.417445-07:00","date_modified":"2026-05-15T14:05:06.431106-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"","attachment_number":null,"pacer_doc_id":"","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Set/Reset Motion and R&R Deadlines/Hearings","acms_document_guid":""}],"date_created":"2026-05-15T14:05:06.393977-07:00","date_modified":"2026-05-15T14:05:06.394004-07:00","date_filed":"2026-05-15","time_filed":"16:48:16","entry_number":null,"recap_sequence_number":"2026-05-15.001","pacer_sequence_number":null,"description":"","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464252194/","id":464252194,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479419790/","id":479419790,"tags":[],"absolute_url":"/docket/70517657/45/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T13:37:08.797385-07:00","date_modified":"2026-05-29T03:19:40.498522-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"45","attachment_number":null,"pacer_doc_id":"119023935086","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Notice of Appearance","acms_document_guid":""}],"date_created":"2026-05-15T13:37:08.756522-07:00","date_modified":"2026-05-29T03:19:40.471028-07:00","date_filed":"2026-05-15","time_filed":"16:33:39","entry_number":45,"recap_sequence_number":"2026-05-15.002","pacer_sequence_number":181,"description":"NOTICE of Appearance by BENJAMIN ISAAC RUBINSTEIN on behalf of AARON ONDREY, ROCKET PHARMACEUTICALS, INC., GAURAV SHAH (RUBINSTEIN, BENJAMIN) (Entered: 05/15/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464228553/","id":464228553,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479395765/","id":479395765,"tags":[],"absolute_url":"/docket/70517657/44/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T12:04:22.791659-07:00","date_modified":"2026-05-29T03:19:40.438902-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"44","attachment_number":null,"pacer_doc_id":"119023933969","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Withdraw as Attorney","acms_document_guid":""}],"date_created":"2026-05-15T12:04:22.756966-07:00","date_modified":"2026-05-29T03:19:40.401671-07:00","date_filed":"2026-05-15","time_filed":"14:42:02","entry_number":44,"recap_sequence_number":"2026-05-15.001","pacer_sequence_number":179,"description":"MOTION to Withdraw as Attorney by Corey Sipmann, DIMITAR YANKOV. (CALANDRA, BRIAN) (Entered: 05/15/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/459474743/","id":459474743,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/474503175/","id":474503175,"tags":[],"absolute_url":"","date_created":"2026-04-02T08:32:50.325709-07:00","date_modified":"2026-05-29T03:19:40.201502-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"","attachment_number":null,"pacer_doc_id":"","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"","acms_document_guid":""}],"date_created":"2026-04-02T08:32:50.308644-07:00","date_modified":"2026-05-29T03:19:40.173910-07:00","date_filed":"2026-02-02","time_filed":null,"entry_number":null,"recap_sequence_number":"2026-02-02.001","pacer_sequence_number":null,"description":"Set Deadlines as to 40 MOTION to Dismiss . Motion set for 3/2/2026 before Judge Zahid N. Quraishi. Unless otherwise directed by the Court, this motion will be decided on the papers and no appearances are required. Note that this is an automatically generated message from the Clerk`s Office and does not supersede any previous or subsequent orders from the Court. (mlh)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/459424026/","id":459424026,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/474450484/","id":474450484,"tags":[],"absolute_url":"/docket/70517657/43/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-04-01T20:37:16.477364-07:00","date_modified":"2026-05-29T03:19:40.365627-07:00","sha1":"84c4439189f5264e9d56eac8362350caa6263095","page_count":50,"file_size":649801,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.0.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.0.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 1 of 50 PageID:\n 1913\n\n\n\nBrian Calandra\nPOMERANTZ LLP\n600 Third Avenue, 20th Floor\nNew York, NY 10016\nTelephone: (212) 661-1100\nFax: (917) 463-1044\nbcalandra@pomlaw.com\n[Additional counsel on signature page]\n\n\nCo-Lead Counsel for Co-Lead Plaintiff\nDimitar Yankov, and the Proposed\nClass\n\n UNITED STATES DISTRICT COURT\n DISTRICT OF NEW JERSEY\n\n Case No. 3:25-cv-10049-ZNQ-TJB\n IN RE ROCKET\n PHARMACEUTICALS, INC. OPPOSITION TO DEFENDANTS\u2019\n SECURITIES LITIGATION\n MOTION TO DISMISS (ECF 40)\n THIS DOCUMENT RELATES TO: THE CONSOLIDATED AMENDED\n CLASS ACTION COMPLAINT\n ALL ACTIONS\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 2 of 50 PageID:\n 1914\n\n\n\n TABLE OF CONTENTS\n\nI. PRELIMINARY STATEMENT .....................................................................1\n\nII. SUMMARY OF ALLEGATIONS AND CLAIMS ........................................5\nIII. PROCEDURAL HISTORY / TEXT ORDER VIOLATION .......................12\n\nIV. ARGUMENT .................................................................................................13\n\n A. APPLICABLE PLEADING STANDARDS ..........................................13\n\n B. THE CAC ADEQUATELY PLEADS FALSITY .................................15\n\n C. THE MISSTATEMENTS AND OMISSIONS ARE NOT\n PROTECTED FROM LIABILITY .......................................................25\n\n D. THE CAC ADEQUATELY PLEADS SCIENTER ...............................31\n E. THE CAC ADEQUATELY PLEADS LOSS CAUSATION ................38\n\n F. THE CAC\u2019S \u00a720(A) CLAIM SHOULD BE SUSTAINED ..................40\nV. CONCLUSION..............................................................................................40\n\n\n\n\n i\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 3 of 50 PageID:\n 1915\n\n\n\n TABLE OF AUTHORITIES\n\n Page(s)\nCases\n\nBarbee v. Amira Nature Foods, Ltd.,\n 2025 WL 2505605 (D.N.J. Sep. 2, 2025) ........................................................... 15\nBell Atl. Corp. v. Twombly,\n 550 U.S. 544 (2007) ............................................................................................ 14\nCarmignac Gestion, S.A. v. Perrigo Co. PLC,\n 2019 WL 3451523 (D.N.J. July 31, 2019) ......................................................... 27\n\nCity of Livonia Emps.' Ret. Sys. v. Wyeth,\n 2010 WL 3910265 (S.D.N.Y. 2010).......................................................21, 23, 25\nCity of Edinburgh Council v. Pfizer, Inc.,\n 754 F.3d 159 (3d Cir. 2014) .......................................................17, 18, 19, 20, 30\n\nCity of Providence v. Aeropostale, Inc.,\n 2013 WL 1197755 (S.D.N.Y. Mar. 25, 2013) .................................................... 36\n\nCity of Warren Police & Fire Ret. Sys. v. Prudential Fin., Inc.,\n 70 F.4th 668 (3d Cir. 2023) ..........................................................................16, 30\n\nCity of Warren Police & Fire Ret. Sys. v. World Wrestling Ent. Inc.,\n 477 F. Supp. 3d 123 (S.D.N.Y. 2020) (Rakoff, J.) ............................................. 14\nCity of Pontiac Gen. Emps.' Ret. Sys. v. Lockheed Martin Corp.,\n 875 F. Supp. 2d 359 (S.D.N.Y. 2012) ................................................................ 32\n\nCohen v. Kitov Pharms. Holdings, Ltd.,\n 2018 WL 1406619 (S.D.N.Y. Mar. 20, 2018) .................................................... 15\n\nCont\u2019l Gen. Ins. Co. v. Olafsson,\n 2024 WL 4263211 (D.N.J. Sep. 23, 2024) (Quraishi, J.) .................17, 23, 25, 27\n\nDudley v. Haub,\n 2013 WL 1845519 (D.N.J. Apr. 30, 2013) ......................................................... 38\nDura Pharms., Inc. v. Broudo,\n 544 U.S. 336 (2005) ............................................................................................ 38\n ii\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 4 of 50 PageID:\n 1916\n\n\n\nFrater v. Hemispherx Biopharma, Inc.,\n 996 F. Supp. 2d 335 (E.D. Pa. 2014) ............................................................20, 24\nFresno Cnty. Emps.' Ret. Ass'n v. comScore, Inc.,\n 268 F. Supp. 3d 526 (S.D.N.Y. 2017) ................................................................ 36\n\nFTC v. Wyndham Worldwide Corp.,\n 799 F.3d 236 (3d Cir. 2015) ............................................................................... 14\n\nGregory v. ProNAi Therapeutics, Inc.,\n 297 F. Supp. 3d 372 (S.D.N.Y. 2018) ................................................................ 18\n\nIn re Advance Auto Parts, Inc. Sec. Litig.,\n 2020 WL 599543 (D. Del. Feb. 7, 2020) ............................................................ 31\n\nIn re Burlington Coat Factory Sec. Litig.,\n 114 F.3d 1410 (3d Cir. 1997) ............................................................................. 16\nIn re Campbell Soup Co. Sec. Litig.,\n 145 F. Supp. 2d 574 (D.N.J. 2001) ..................................................................... 15\nIn re Celgene Corp. Sec. Litig.,\n 2019 WL 6909463 (D.N.J. Dec. 19, 2019) .............................................20, 24, 25\n\nIn re Cognizant Tech. Sols. Corp. Sec. Litig.,\n 2020 WL 3026564 (D.N.J. June 5, 2020) ........................................................... 38\nIn re Dr. Reddy\u2019s Lab\u2019y Ltd. Sec. Litig.,\n 2019 WL 1299673 (D.N.J. Mar. 20, 2019) ........................................................ 27\nIn re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II),\n 751 F.3d 150 (3d Cir. 2014) ............................................................................... 36\nIn re Hertz Glob. Holdings, Inc.,\n 905 F.3d 106 (3d Cir. 2018) ............................................................................... 38\n\nIn re Hertz Glob. Holdings, Inc. Sec. Litig.,\n 2017 WL 1536223 (D.N.J. Apr. 27, 2017),\n aff\u2019d, 905 F.3d 106 (3d Cir. 2018) ...................................................................... 29\n\nIn re Innocoll Holdings Pub. Ltd. Sec. Litig.,\n 2020 WL 1479128 (E.D. Pa. March 25, 2020)................................................... 29\n\n\n iii\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 5 of 50 PageID:\n 1917\n\n\n\nIn re Lucent Techs., Inc. Sec. Litig.,\n 217 F. Supp. 2d 529 (D.N.J. 2002) ..................................................................... 14\nIn re Merck & Co., Inc. Sec., Derivative, & ERISA Litig.,\n 2011 WL 3444199 (D.N.J. Aug. 8, 2011) .......................................................... 39\n\nIn re NUI Sec. Litig.,\n 314 F. Supp. 2d 388 (D.N.J. 2004) ..................................................................... 37\n\nIn re Par Pharm. Sec. Litig.,\n 2009 WL 3234273 (D.N.J. Sep. 30, 2009) ......................................................... 38\n\nIn re Res. Am. Sec. Litig.,\n 2000 WL 1053861 (E.D. Pa. July 26, 2000) ...................................................... 37\n\nIn re Sanofi Sec. Litig.,\n 87 F. Supp. 3d 510 (S.D.N.Y. 2015) ............................................................18, 30\nIn re Silvercorp Metals, Inc. Sec. Litig.,\n 26 F. Supp. 3d 266 (S.D.N.Y. 2014) .................................................................. 37\nIn re SLM Corp. Sec. Litig.,\n 740 F. Supp. 2d 542 (S.D.N.Y. 2010) ................................................................ 37\n\nIn re Toronto-Dominion Bank Sec. Litig.,\n 2018 WL 6381882 (D.N.J. Dec. 6, 2018) ........................................................... 37\nIn re Urban Outfitters, Inc. Sec. Litig.,\n 103 F. Supp. 3d 635 (E.D. Pa. 2015) ............................................................39, 40\nIn re Valeant Pharms. Int\u2019l, Inc. Sec. Litig.,\n 2017 WL 1658822 (D.N.J. Apr. 28, 2017) ......................................................... 38\nIndustriens Pensionsforsikring A/S v. Becton, Dickinson & Co.,\n 620 F. Supp. 3d 167 (D.N.J. 2022) ...................................................20, 24, 25, 30\n\nInstitutional Invs. Grp. v. Avaya, Inc.,\n 564 F.3d 242 (3d Cir. 2009) ................................................ 14, 16, 23, 27, 28, 29\n\nIowa Pub. Emps.' Ret. Sys. v. MF Glob., Ltd.,\n 620 F.3d 137 (2d Cir. 2010) ............................................................................... 27\n\n\n\n iv\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 6 of 50 PageID:\n 1918\n\n\n\nJohnson v. Pozen, Inc.,\n 2009 U.S. Dist. LEXIS 12765 (M.D.N.C. Feb. 19, 2009) ................................. 18\nJohnston v. HBO Film Mgmt., Inc.,\n 265 F.3d 178 (3d Cir. 2001) ............................................................................... 23\n\nKendall v. Odonate Therapeutics, Inc.,\n 2021 WL 3406271 (S.D. Cal. Aug. 4, 2021) ...................................................... 37\n\nLangford v. Atlantic City,\n 235 F.3d 845 (3d Cir. 2000) ............................................................................... 14\n\nLevon v. CorMedix Inc.,\n 797 F. Supp. 3d 381 (D.N.J. 2025) .................... 20, 22, 23, 25, 29, 30, 31, 37, 39\n\nMatrixx Initiatives, Inc. v. Siracusano,\n 563 U.S. 27 (2011) ......................................................................17, 23, 25, 32, 34\nMcCabe v. Ernst & Young, LLP,\n 494 F.3d 418 (3d Cir. 2007) ............................................................................... 39\nNovak v. Kasaks,\n 216 F.3d 300 (2d Cir. 2000) ............................................................................... 35\n\nOmnicare, Inc. v. Laborers Dist. Council Constr. Indus. Pension Fund,\n 575 U.S. 175 (2015) ............................................................................................ 31\nOpengate Cap. Grp. LLC v. Thermo Fisher Sci. Inc.,\n 2014 WL 3367675 (D. Del. July 8, 2014) .......................................................... 14\nOran v. Stafford,\n 226 F.3d 275 (3d Cir. 2000) ................................................................................. 7\nRahman v. Kid Brands, Inc.,\n 736 F.3d 237 (3d Cir. 2013) ............................................................................... 32\n\nRoofer\u2019s Pension Fund v. Papa,\n 2018 WL 3601229 (D.N.J. July 27, 2018) ...................................................36, 38\n\nSchmidt v. Skolas,\n 770 F.3d 241 (3d Cir. 2014) ................................................................................. 6\n\n\n\n v\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 7 of 50 PageID:\n 1919\n\n\n\nSEB Inv. Mgmt. AB v. Endo Int\u2019l, PLC,\n 351 F. Supp. 3d 874 (E.D. Pa. 2018) .................................................................. 21\nShulman v. Weston,\n 2025 WL 3754159 (D.N.J. Dec. 29, 2025) ......................................................... 28\n\nTellabs, Inc. v. Makor Issues & Rts., Ltd.,\n 551 U.S. 308 (2007) ..........................................................................31, 32, 33, 34\n\nVan Dongen v. CNinsure, Inc.,\n 951 F. Supp. 2d 457 (S.D.N.Y. 2013) ................................................................ 37\n\nWhiteley v. Zynerba Pharms., Inc.,\n 2020 WL 13879653 (E.D. Pa. Nov. 25, 2020) .................................21, 22, 23, 25\n\nWilliams v. Globus Med., Inc.,\n 869 F.3d 235 (3d Cir. 2017) ............................................................................... 17\nWiner Fam. Tr. v. Queen,\n 503 F.3d 319 (3d Cir. 2007) ............................................................................... 14\n Statutes\n\n15 U.S.C. 78u-5(i)(1) ............................................................................................... 27\n\n15 U.S.C. 78u-5(c) ................................................................................................... 25\n\n15 U.S.C. 78u-5(c)(1)(A)(i) ..................................................................................... 28\n15 U.S.C. \u00a778u-5(c)(1)(A)(i) ................................................................................... 28\nPrivate Securities Litigation Reform Act of 1995 .............. 14, 15, 16, 25, 27, 29, 38\n\nSecurities Exchange Act of 1934 \u00a710(b) .................................................5, 13, 16, 40\n\n Rules\n\nFed. R. Civ. P. 8(a)................................................................................................... 38\n\nFed. R. Civ. P. 9(b) ......................................................................................15, 16, 38\n\nFed. R. Civ. P. 12(b)(6)................................................................................12, 14, 36\nSecurities and Exchange Commission Rule 10b-5 ........................................5, 13, 16\n\n vi\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 8 of 50 PageID:\n 1920\n\n\n\nSecurities and Exchange Commission Rule 10b5-1 ................................................ 36\n\n Regulations\n21 C.F.R. \u00a7312.64 .................................................................................................... 35\n\n\n\n\n vii\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 9 of 50 PageID:\n 1921\n\n\n\n Lead Plaintiffs Dimitar Yankov and Corey Sipmann respectfully submit this\n\nopposition to Defendants\u2019 motion to dismiss (ECF 40) (\u201cMotion\u201d) challenging the\n\nConsolidated Amended Class Action Complaint (ECF 34) (\u201cCAC\u201d) for the reasons\n\nset forth in Defendants\u2019 memorandum of law (ECF 40-1) (\u201cMemo\u201d).1\n\nI. PRELIMINARY STATEMENT\n\n During Rocket\u2019s Phase 1 trial of its drug candidate A501, one patient suffered\n\nan SAE (serious adverse event) involving TMA (thrombotic microangiopathy),\n\ncausing an FDA clinical hold and a reduced patient headcount from seven to six.\n\n\u00b6\u00b64, 41. Rocket said the TMA was caused by complement activation, a rapid\n\nimmune response to either pathogens or to gene therapies like A501. \u00b6\u00b639, 41.\n\n Consequently, Rocket had to convince FDA and investors it could manage the\n\nTMA / complement activation risk in a Phase 2 trial. So, \u201cRocket purportedly\n\nimplemented additional safety measures for the Phase 2 Trial.\u201d \u00b646. Principally,\n\nRocket only attempted the Phase 1 \u201clow dose\u201d for Phase 2 (\u00b645), after the TMA-\n\nrelated SAE in Phase 1 occurred in a patient given the \u201chigh dose\u201d (\u00b662(a)). Rocket\n\nalso excluded patients with end-stage heart failure and used a complement activation\n\nsuppression regimen (a/k/a a \u201crefined immunomodulatory regimen\u201d) administered\n\nbefore A501 in trial patients and continuing 2-3 months after dosing. \u00b6\u00b65, 8. These\n\n\n1\n Unless specified, herein, \u201c\u00b6\u201d cites are to CAC-numbered paragraphs, \u201cExh.\u201d\nRefers to Defendants\u2019 exhibits, all terms have CAC-assigned definitions, all\nemphasis is added and all internal citations and quotation marks are omitted.\n 1\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 10 of 50 PageID:\n 1922\n\n\n\n steps were already taken as predicates for the Phase 2 Trial, and Rocket\u2019s quarterly\n\n filings throughout the Class Period said, \u201cAdditional safety measures have been\n\n implemented and are reflected in the updated trial protocol.\u201d \u00b6\u00b68, 46, 62(a).\n\n This case arises from Defendants\u2019 public statements and omissions regarding\n\n Rocket\u2019s ensuing 12-patient Phase 2 Trial of A501. \u00b6\u00b63, 43. It was enrolled in two\n\n stages: a \u201ctwo-patient safety run-in\u201d after which \u201cthe remaining ten patients were\n\n enrolled across the United States and European Union within three months.\u201d \u00b646.\n\n \u201cA safety run-in is an initial phase of a clinical trial to assess the short-term safety\n\n and tolerability of a treatment combination.\u201d Id. The run-in patients were not only\n\n part of the Phase 2 Trial patient population, they were specifically designated to\n\n assess A501\u2019s \u201csafety and tolerability.\u201d Id. Rocket\u2019s SEC filings, e.g., Exhibits 1-\n\n 2 hereto as described below, expressly stated so.\n\n Disastrously, the very first patient in the Phase 2 Trial, an adolescent boy\n\n from Chicago dosed in early 2024, experienced a TMA-related SAE, an acute kidney\n\n injury, that forced his hospitalization for months in Philadelphia. \u00b658. During that\n\n time, Rocket flew out senior clinical and medical personnel, halted trial dosing, and\n\n conducted a root cause analysis. Id. Later, the fourth patient dosed, a boy in\n\n Germany, suffered a TMA-related kidney injury SAE in August 2024 requiring\n\n extended hospitalization, due to a preconditioning drug used in trying to prevent\n\n complement activation. Id. During the ensuing nine-month dosing halt, Defendants\n\n 2\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 11 of 50 PageID:\n 1923\n\n\n\n decided in January 2025 to modify the Phase 2 Trial by introducing a new-to-market\n\n C3 inhibitor as an alternative to suppress complement activation to address Phase\n\n 2\u2019s persistent SAEs, then sought FDA approval. \u00b6\u00b65, 10, 52, 81(c). The inhibitor\n\n carried its own dangers and increased the Phase 2 Trial\u2019s overall risk profile. \u00b653 &\n\n n.1; \u00b681(c), (f). When dosing resumed in May 2025, the fifth and sixth dosed\n\n patients suffered SAEs related to CLS (capillary leak syndrome) due to the inhibitor\n\n and were hospitalized; one died shortly after FDA imposed a clinical hold on May\n\n 23, 2025. \u00b6\u00b65, 12. Throughout the Class Period, Defendants misrepresented and/or\n\n concealed all these facts and Rocket\u2019s inability to safely manage A501\u2019s SAE risks.\n\n Defendants blatantly seek to rewrite both the CAC and the facts of the Phase\n\n 2 Trial itself to create an alternative narrative on which their entire brief rests.\n\n First, they add the phrase \u201cno more than\u201d to the CAC\u2019s definition of the \u201ctwo-\n\n patient safety run-in,\u201d falsely claiming it was \u201cno more than an initial phase of a\n\n clinical trial to assess the short-term safety and tolerability of a treatment\n\n combination.\u201d See, e.g., Memo at 5. Without citation, Defendants seek to excise\n\n the first two of the six dosed Phase 2 Trial patients, those specifically intended to\n\n flag safety issues. They claim, in effect, that the first patient dosed, who required\n\n months of hospitalization, does not count. The Memo proceeds as if he never\n\n existed, a root cause analysis into his SAE was never conducted, dosing was never\n\n halted, and no FDA engagement concerning him ever occurred. Defendants base all\n\n 3\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 12 of 50 PageID:\n 1924\n\n\n\n ensuing argument on an alternative reality wherein no TMA-related SAE occurred\n\n until the fourth patient in the trial, leading to the C3 inhibitor. Even then, Defendants\n\n argue (e.g., Memo at 2, 6) the third and fourth SAEs, suffered in May 2025 after the\n\n novel C3 inhibitor was introduced, were the first giving rise to any disclosure duty.\n\n The Defendants cannot rewrite or ignore the CAC\u2019s allegations at the pleading stage.\n\n Second, Defendants rewrite Rocket\u2019s past-tense statements that \u201cadditional\n\n safety measures have been implemented\u201d after the Phase 1 trial, for the Phase 2 Trial\n\n protocol, into future-tense, open-ended statements that Rocket \u201cwould implement\n\n additional safety measures not employed in Phase 1.\u201d See, e.g., Memo at 6, 7. They\n\n falsely claim investors were told Rocket intended to make safety-related adjustments\n\n to the Phase 2 Trial, not that safety measures were already employed during Phase 2\n\n planning and FDA trial approval. They use this alternate reality to justify concealing\n\n from investors, e.g., that the Phase 2 Trial protocol was later redone, after two dosing\n\n halts and a root cause analysis prompted by two SAEs in the first four patients, to\n\n replace its complement activation suppression regimen with the C3 inhibitor.\n\n Third, and relatedly, Defendants falsely claim that the novel C3 inhibitor was\n\n added to the pretreatment regimen \u201cin light of the SAEs experienced in Phase 1.\u201d\n\n See, e.g., Memo at 2. That is not what the CAC (\u00b65) alleges. All measures adopted\n\n \u201cin light of the SAEs experienced in Phase 1\u201d had already been adopted into the\n\n Phase 2 Trial protocol that was approved and implemented at its start. It was only\n\n 4\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 13 of 50 PageID:\n 1925\n\n\n\n after two Phase 2 patients experienced TMA-related SAEs, prompting two dosing\n\n halts, that Defendant decided, unbeknownst to investors, to add the novel C3\n\n inhibitor, leading to two CLS-related SAEs and a patient death. \u00b65.\n\n This trickery should be rejected. The CAC\u2019s well-pled allegations must be\n\n accepted as true and construed in Lead Plaintiffs\u2019 favor. If they are, Defendants\u2019\n\n dismissal arguments collapse. Their Motion should be entirely rejected.\n\n II. SUMMARY OF ALLEGATIONS AND CLAIMS\n\n The CAC raises claims under \u00a7\u00a710(b) and 20(a) of the Securities Exchange\n\n Act of 1934 and Rule 10b-5 promulgated thereunder on behalf of a Class of investors\n\n who purchased or acquired Rocket\u2019s securities during the Class Period of February\n\n 28, 2024 - August 25, 2025. \u00b62. Defendants allegedly committed fraud in their\n\n public statements and omissions about Rocket\u2019s 12-patient Phase 2 Trial of its key\n\n gene therapy drug candidate, RP-A501 (a/k/a A501), one of its two top prospects\n\n and the one having the highest economic upside. \u00b63.\n\n Pre-Class Period, during Rocket\u2019s seven-patient Phase 1 trial, one patient\n\n suffered a TMA-related SAE and failed to complete the trial, reducing its headcount\n\n and prompting an FDA to impose a trial hold. \u00b6\u00b64, 41. Rocket said the TMA was\n\n caused by complement activation, a rapid immune response to either pathogens or\n\n to intended gene therapies like A501. \u00b6\u00b639, 41.\n\n Rocket then had to convince FDA and the market it could manage these risks\n\n\n 5\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 14 of 50 PageID:\n 1926\n\n\n\n in a Phase 2 trial. Thus, Rocket implemented new safety measures for the Phase 2\n\n Trial, primarily to prevent complement activation. \u00b646. It only used the lower of\n\n the two Phase 1 trial doses (6.7\u00d71013 gc/kg). \u00b6\u00b637, 45. It also excluded patients with\n\n end-stage heart failure and used a complement activation suppression regimen (its\n\n \u201crefined immunomodulatory regimen\u201d) administered to patients before A501 and\n\n continuing 2-3 months after dosing. \u00b6\u00b65, 8.2 These steps were predicates for the\n\n Phase 2 Trial, and Rocket\u2019s quarterly filings said, \u201cAdditional safety measures have\n\n been implemented and are reflected in the updated trial protocol.\u201d \u00b6\u00b68, 62(a).\n\n Thus, Defendants are wrong to suggest (see, e.g., Memo at 2, 4-5, 16) that\n\n because the Phase 1 trial\u2019s TMA incident was discussed in the New England Journal\n\n of Medicine (\u201cNEJM\u201d) in November 2024 \u2013 nine months into the Class Period \u2013\n\n the Phase 2 Trial\u2019s SAE risks were \u201cwell publicized and well known.\u201d3 After Phase\n\n\n\n 2\n The regimen: (a) added transient B- and T-cell mediated inhibition in\n pretreatment; (b) lowered steroid doses; (c) did an earlier steroid taper; and (d)\n discontinued all immunosuppressive therapy 2-3 months post-A501. \u00b6\u00b68, 62(a)-(b).\n 3\n Lead Plaintiffs oppose Defendants\u2019 request for judicial notice (Memo at 5 n.2)\n of the NEJM article (Exh. A), as well as purported slide decks (Exhs. BB, CC, EE)\n from the 1/8/2024 JPM Conference, 11/18/2024 Webinar, and 1/13/2025 JPM\n Conference. The CAC alleges only that Defendant Shah discussed Rocket\u2019s\n publishing Phase 1 trial data in the NEJM (\u00b669); it does not reference or incorporate\n the article itself. The CAC references oral remarks at those conferences / webinar,\n but not any purported slide decks. See \u00b6\u00b645, 69, 72, 81(a)-(c), 81(e)-(f), 121.\n Defendants do not even request judicial notice for the articles cited in Memo at 6\n n.3, and none should be taken. All the foregoing documents should be disregarded.\n See, e.g., Schmidt v. Skolas, 770 F.3d 241, 249-250 (3d Cir. 2014) (improper for\n district court to take judicial notice of materials \u201cnot integral to the complaint\u201d).\n 6\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 15 of 50 PageID:\n 1927\n\n\n\n 1, Rocket purportedly addressed its SAE, via the Phase 2 Trial\u2019s protocol design.4\n\n The Phase 2 Trial\u2019s risk profile, given these steps, was thus not publicly known.\n\n In this context, investors and analysts entered the Class Period seeking timely,\n\n accurate, complete disclosures about Rocket\u2019s Phase 2 Trial, particularly its risks\n\n and incidences of SAEs, including TMA-related incidents. \u00b64. Unbeknownst to\n\n investors, the Phase 2 Trial, starting with its very first patient, was beset with SAEs\n\n impacting four of the first six dosed patients, one of whom died. \u00b65.\n\n The first, a pediatric patient dosed in early 2024, suffered a TMA-related SAE\n\n and remained hospitalized for months with kidney injury. \u00b6\u00b65, 47, 58. Rocket halted\n\n dosing, flew senior personnel to his doctors, and initiated a root cause analysis. Id.\n\n This patient was in the two-patient pediatric safety run-in (\u00b6\u00b69, 46), intended to\n\n identify \u201ckey AAV-associated toxicities\u201d before other pediatric patients were dosed,\n\n and was clearly part of the 12-patient Phase 2 Trial study population \u2013 as Rocket\u2019s\n\n SEC filings made clear, e.g., this chart filed with the SEC September 12, 2023:5\n\n\n\n 4\n Defendants falsely claim (e.g., Memo at 2) the C3 inhibitor was introduced\n \u201cin light of the SAEs experienced in Phase 1.\u201d Not so. It only arose after the two\n Phase 2 TMA-related SAEs. \u00b65; \u00a7II, supra.\n 5\n This chart is from page 8 of Rocket\u2019s Investor Presentation (\u201c9/12/2023\n Presentation\u201d), Exhibit 99.1 to its Form 8-K (\u201c9/12/2023 8-K\u201d) filed with the SEC\n on September 12, 2023 to update investors on \u201cthe alignment it recently achieved\n with [FDA] on the design of the Phase 2 pivotal trial of RP-A501.\u201d The Court can\n take judicial notice of the Form 8-K and the presentation, as Lead Plaintiffs\u2019 Exhibits\n 1-2. Oran v. Stafford, 226 F.3d 275, 289 (3d Cir. 2000) (court may take \u201cjudicial\n notice of properly-authenticated public disclosure documents filed with the SEC\u201d).\n 7\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 16 of 50 PageID:\n 1928\n\n\n\n\n After persuading FDA this patient had a genetic mutation predisposing him to\n\n an SAE, the Phase 2 Trial resumed. \u00b6\u00b65, 58. But, the fourth dosed patient suffered\n\n a TMA-related SAE in August 2024, also with a long hospitalization, due to kidney\n\n injury arising from the complement activation suppression regimen meant to lower\n\n A501\u2019s TMA risk. Id. Rocket halted further patient dosing until May 2025. \u00b6\u00b65,\n\n 10. Notably, both these TMA-related SAEs occurred before Defendants claim\n\n (Memo at 2, 4-5, 16) the NEJM discussed the Phase 1 trial\u2019s SAE in November 2024.\n\n By January 2025, Defendants decided to introduce the novel C3 inhibitor to\n\n suppress complement activation and engaged with FDA on a trial redesign. \u00b6\u00b65, 52,\n\n 59, 81(c). In May 2025, the fifth and sixth patients were dosed and given the C3\n\n inhibitor, and both suffered CLS-related SAEs, causing hospitalizations. \u00b6\u00b65, 12,\n\n 47, 53, 56, 81(d). These were the third and fourth SAEs suffered within only six\n\n 8\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 17 of 50 PageID:\n 1929\n\n\n\n patients dosed in the Phase 2 Trial. FDA imposed a clinical hold on May 23, 2025,\n\n just before one of those patients died. \u00b6\u00b65, 12, 49, 53. The Phase 2 Trial was halted\n\n at that point and still has not resumed. \u00b6\u00b613, 103.\n\n Defendants\u2019 material misstatements and omissions throughout the Class\n\n Period misrepresented and/or concealed all these facts. \u00b6\u00b67-11, 61-81. For instance:\n\n \u2022 Defendants touted the \u201clow dose\u201d and \u201c[a]dditional safety measures\u201d\n\n implemented in the Phase 2 Trial \u201cto mitigate complement-mediated safety concerns\n\n observed in the high dose cohort (thrombotic microangiopathy (TMA)),\u201d with an\n\n \u201cemphasis on preventing complement activation\u201d \u2013 failing to adjust the language\n\n despite mounting contrary evidence, e.g., SAEs, dosing holds, etc. \u00b6\u00b68, 62(a)-(b).\n\n \u2022 Defendants discussed the first two patients, the safety run-in, while\n\n concealing the first one\u2019s SAE, e.g., \u201cThe pediatric run-in enrolled two patients in a\n\n sequential manner with a minimum three-month follow-up prior to subsequent\n\n enrollment,\u201d \u201ctwo patients were treated earlier, followed for a certain time, discussed\n\n with FDA and IDMC, and then we started the broader trial,\u201d and \u201cwe had a two-\n\n patient run-in, right, and the patients had to be staggered too. And then you talk to\n\n the FDA again. So it just takes time to get there.\u201d \u00b6\u00b69, 11, 65-66, 68(b), 79(b).\n\n \u2022 They touted Rocket\u2019s purported dosing progress, while concealing that\n\n four of six dosed patients experienced SAEs, causing multiple extended dosing\n\n delays, stating, e.g., \u201cwe\u2019re finishing dosing as fast as possible,\u201d \u201cdosing and follow-\n\n 9\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 18 of 50 PageID:\n 1930\n\n\n\n up are ongoing,\u201d and \u201cthe trial and follow-up are ongoing.\u201d \u00b6\u00b610, 72, 73(b), 77.\n\n \u2022 Defendants attributed Phase 2 Trial delays to benign, generic causes,\n\n not the actual, SAE-caused setbacks, stating, e.g., \u201cgetting everyone dosed just takes\n\n some time,\u201d \u201cthis is a \u2013 in some ways, a heavy protocol. We\u2019re looking at a lot of\n\n different measures. So, it just takes time to get all of those up and running. So,\n\n that\u2019s why the enrollment is different from the actual dosing,\u201d and\n\n \u201cNumber one, these patients require immunomodulation. So, that takes\n time to set up and source appropriately. Number two, there\u2019s some\n vaccines involved in immunomodulation, which also takes time.\n There\u2019s a troponin run-in, number three, of three months that the FDA\n mandates. \u2026 [I]nstead of putting everyone at one site, we try to stagger\n them. So, that takes a little bit of time. \u2026 So, all this, along with the\n holidays, has added the time up, \u2026 but it is getting done.\u201d\n\n \u00b6\u00b611, 65, 68(b), 70(b), 74.\n\n \u2022 Once a patient died, Defendants finally disclosed the four SAEs, but\n\n downplayed them, e.g., the complement activation and TMA \u201cwas part of routine\n\n explained side effects of gene therapy\u201d with \u201cno clinical hold.\u201d \u00b6\u00b678(b), 79(b). They\n\n also concealed that Rocket lacked any way to safely dose patients while effectively\n\n managing SAE risks, e.g., \u201cwe remain committed to advancing RP-A501 with the\n\n highest standards of safety, science, and care,\u201d \u201cthere are various ways to move\n\n forward, including revising the immunomodulatory regimen perhaps to a simpler\n\n one,\u201d \u201cwe\u2019re confident that there is a path forward with the simplified regimen here,\u201d\n\n \u201cRocket is actively working with FDA, independent safety monitors, and clinical\n\n\n 10\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 19 of 50 PageID:\n 1931\n\n\n\n experts to ensure patient safety and resume the trial,\u201d \u201cWe\u2019re already in deep\n\n dialogue with FDA back and forth and doing a neutral, objective root cause analysis.\n\n We\u2019re discussing with them a potential revising immunomodulatory regimen,\u201d and\n\n \u201cThe hold was lifted in under three months, underscoring\u2026Rocket\u2019s commitment\n\n to expeditiously optimize safety and resume the trial.\u201d \u00b6\u00b678(a), 78(c)-(e), 79(a), 80.\n\n The CAC also adequately pleads Defendants\u2019 scienter. \u00b6\u00b694-118. It alleges\n\n Defendants knew of all SAEs immediately, as regulations require (\u00b6\u00b66, 98-99), and\n\n of negative, undisclosed facts making their statements false or misleading (\u00b6\u00b647-60).\n\n It sets the timeline of their knowledge (\u00b6\u00b6100-102) and alleges that A501 was in\n\n Rocket\u2019s core operations (\u00b6\u00b6104-106), the fraud violated its Code of Conduct\n\n (\u00b6\u00b6115-118), and Defendants Shah and Ondrey signed, were quoted in, and SOX-\n\n certified the alleged misstatements (\u00b6\u00b6107-108). Yet, Defendants concealed the\n\n Phase 2 Trial SAEs and related events until a May 2025 patient death and concealed\n\n into August 2025 that Rocket lacked a viable trial design to safely dose patients with\n\n A501 while effectively managing SAE risks. \u00b66. Rocket raised $182.5 million via\n\n offerings at fraud-inflated prices, during an undisclosed Phase 2 dosing halt and just\n\n before it decided to employ the ill-fated C3 inhibitor. \u00b6\u00b614, 96-97. Defendants Shah\n\n ($769,000+) and Ondrey (~$44,000) made fraud-inflated sale proceeds during the\n\n fraud. \u00b6\u00b614, 95(a)-(b). The Phase 2 Trial remains halted (\u00b6103), while Defendant\n\n Ondrey (CFO), Rocket\u2019s COO, and its Chief Medical Officer resigned (\u00b6\u00b6109-114).\n\n 11\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 20 of 50 PageID:\n 1932\n\n\n\n A series of partial corrective disclosures allegedly revealed the fraud. \u00b6\u00b612-\n\n 13, 82-93. On May 27, 2025, Rocket disclosed the four prior SAEs, patient death,\n\n FDA clinical hold, and related facts, prompting pre-market-close analyst reports,\n\n which are collectively pled as causing Rocket\u2019s stock to fall -$3.94 / share (-62.84%)\n\n that day. Id.6 Defendants nonetheless said the Phase 2 Trial had paths forward. Id.\n\n But even after FDA lifted the clinical hold, rather than resuming dosing, resignations\n\n in August 2025 by Rocket\u2019s President / COO, who was key in developing and\n\n advancing A501, and Defendant Ondrey prompted stock declines of -$0.23 / share\n\n (-7.44%) on August 8, 2025 and -$0.15 / share (-4.24%) on August 26, 2025. Id.\n\n III. PROCEDURAL HISTORY / TEXT ORDER VIOLATION\n\n On September 9, 2025, the Court appointed Lead Plaintiffs. ECF 22.\n\n Defendants filed their three-page letter outlining Rule 12(b)(6) arguments on\n\n December 9, 2025 (ECF 35) (\u201cMTD Letter\u201d), and Lead Plaintiffs responded on\n\n December 16, 2025 (ECF 36). The Court\u2019s ensuing Text Order (ECF 37) stated:\n\n TEXT ORDER that the Court has reviewed the parties\u2019 pre-motion\n letters (ECFs 35, 36) and hereby WAIVES the pre-motion conference.\n Defendants shall file their Motion, limited to the arguments set forth\n in their pre-motion letter\u2026.\n\n\n\n 6\n Defendants\u2019 Memo at 3 n.1 cites the Memorial Day weekend to justify waiting\n to disclose these facts, but the market closure did not necessitate that wait and it does\n not excuse their long-concealing the Phase 2 Trial\u2019s SAE history. Their Memo at 7\n notes the May 27, 2025 statements \u201cdisclosed the SAE experienced by two patients\n in the Phase 2 study\u201d \u2013 but that was also the first, belated disclosure of all four SAEs.\n 12\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 21 of 50 PageID:\n 1933\n\n\n\n Defendants moved on January 30, 2026 (ECF 40).\n\n Defendants\u2019 Motion and Memo clearly violated the Text Order by including\n\n extensive argument not appearing in their MTD Letter, specifically: (1) their new\n\n arguments challenging the CAC\u2019s confidential witness (CW) allegations (see Memo\n\n at 11 n.4); (2) their extensive new arguments \u2013 spanning 30% of their brief \u2013\n\n referencing purported risk warnings (see Memo at 16, 18-19, 23-32); and (3) their\n\n loss causation arguments targeting the alleged corrective disclosures / stock drops\n\n following key resignations on August 8 and 26, 2025 (see Memo at 37 n.5).\n\n All these arguments exceed the MTD Letter\u2019s scope and should be stricken.\n\n The letter does not mention \u201cconfidential witness,\u201d \u201cCW,\u201d or \u201cwarning.\u201d It included\n\n only one reference to \u201ccautionary language\u201d in one sentence (ECF 35 at 2), but as\n\n Lead Plaintiffs noted, did \u201cnot identify any purported warnings\u2026.\u201d ECF 36 at 2.\n\n The MTD Letter\u2019s loss causation argument was expressly limited to the May 2025\n\n corrective disclosure / stock drop. ECF 35 at 3. Lead Plaintiffs noted the omission:\n\n \u201cDefendants ignore the other two alleged corrective stock drops \u2026.\u201d ECF 36 at 3.\n\n IV. ARGUMENT\n\n A. APPLICABLE PLEADING STANDARDS\n\n To state a claim under Exchange Act \u00a710(b) and Rule 10b-5, a plaintiff must\n\n \u201callege defendants made a misstatement or an omission of material fact with scienter\n\n in connection with the purchase or the sale of a security upon which plaintiffs\n\n\n 13\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 22 of 50 PageID:\n 1934\n\n\n\n reasonably relied and plaintiffs\u2019 reliance was the proximate cause of their injury.\u201d\n\n Institutional Invs. Grp. v. Avaya, Inc., 564 F.3d 242, 251 (3d Cir. 2009) (quoting\n\n Winer Fam. Tr. v. Queen, 503 F.3d 319, 325 (3d Cir. 2007)). On a Rule 12(b)(6)\n\n motion, a court must \u201caccept all factual allegations as true, construe the complaint\n\n in the light most favorable to the plaintiff, and determine whether, under any\n\n reasonable reading of the complaint, the plaintiff may be entitled to relief.\u201d FTC v.\n\n Wyndham Worldwide Corp., 799 F.3d 236, 242 (3d Cir. 2015). The issue is not\n\n whether a plaintiff will ultimately prevail but whether he is entitled to offer evidence\n\n to support the claims. In re Lucent Techs., Inc. Sec. Litig., 217 F. Supp. 2d 529, 540\n\n (D.N.J. 2002) (citing, inter alia, Langford v. Atlantic City, 235 F.3d 845, 847 (3d\n\n Cir. 2000)). Even under the PSLRA, a Rule 12(b)(6) motion is not the stage \u201cto\n\n resolve disputed facts or decide the merits of the case.\u201d Opengate Cap. Grp. LLC v.\n\n Thermo Fisher Sci. Inc., 2014 WL 3367675, at *5 (D. Del. July 8, 2014) (citing Bell\n\n Atl. Corp. v. Twombly, 550 U.S. 544, 555-557 (2007)).\n\n In articulating pleadings standards, Defendants raise two meritless arguments.\n\n First, Defendants belatedly challenge the CAC\u2019s CW allegations, for failure to plead\n\n their titles. Memo at 11 n.4. If considered (see \u00a7III, supra), the argument fails. CAC\n\n \u00b627 pleads the CWs\u2019 retaliation concerns if their titles were publicly docketed and\n\n offered such information for in camera review. That approach suffices.7 Second,\n\n\n 7\n See, e.g., City of Warren Police & Fire Ret. Sys. v. World Wrestling Ent. Inc.,\n 14\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 23 of 50 PageID:\n 1935\n\n\n\n they argue, without citation, \u201cliability cannot be imposed in this case for the\n\n additional reason that the claims asserted arose from an unexpected event that the\n\n Defendants had sought to avoid.\u201d Memo at 11-12. This is not a breach of fiduciary\n\n duty or negligence case. Liability arises from alleged misstatements and omissions\n\n to investors. There were at least four \u201cevents\u201d (the SAEs), if not more (dosing halts,\n\n root cause analyses, etc.). Whether Defendants tried to \u201cavoid\u201d them is irrelevant;\n\n what matters is their allegedly fraudulent statements misrepresenting or omitting\n\n those events. See, e.g., In re Campbell Soup Co. Sec. Litig., 145 F. Supp. 2d 574,\n\n 598 (D.N.J. 2001) (\u201cEven if Defendants did not think that their improper behavior\n\n would \u2018catch up with them,\u2019 that does not somehow make their failure to disclose\n\n material information acceptable or negate their knowledge of the omission.\u201d).\n\n B. THE CAC ADEQUATELY PLEADS FALSITY\n\n Neither the PSLRA nor Rule 9(b) create an insurmountable pleading hurdle.\n\n See Barbee v. Amira Nature Foods, Ltd., 2025 WL 2505605, at *3-4 (D.N.J. Sep. 2,\n\n 2025) (\u201cIrrefutable evidence of a statement\u2019s falsity need not be pleaded pursuant to\n\n Rule 9(b) or the PSLRA, but rather the \u2018complaint must contain particularized\n\n\n\n 477 F. Supp. 3d 123, 132 & n.1 (S.D.N.Y. 2020) (Rakoff, J.) (where retaliation threat\n alleged, CW was described such that it was \u201cprobable that CW-1 would have had\n access to information\u201d stated, and court considered it even without in camera review\n of CW title that plaintiff offered); Cohen v. Kitov Pharms. Holdings, Ltd., 2018 WL\n 1406619, at *9 (S.D.N.Y. Mar. 20, 2018) (CWs described as \u201cformer consultants of\n Kitov with knowledge of the clinical trial results,\u201d sufficed because \u201cany more\n detailed description\u2026likely would reveal the identity of the source\u201d).\n 15\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 24 of 50 PageID:\n 1936\n\n\n\n factual allegations that plausibly allege that a statement was misleading.\u2019\u201d (quoting\n\n City of Warren Police & Fire Ret. Sys. v. Prudential Fin., Inc., 70 F.4th 668, 681\n\n (3d Cir. 2023))). The PSLRA and Rule 9(b) simply \u201crequire[] plaintiffs to plead the\n\n who, what, when, where, and how: the first paragraph of any newspaper story.\u201d\n\n Avaya, 564 F.3d at 253; see also Prudential, 70 F.4th at 680 (PSLRA and Rule 9(b)\n\n require complaint state each misstatement\u2019s or omission\u2019s time, place, contents,\n\n speaker identity, and reasons why false or misleading). The CAC complies, setting\n\n forth every alleged misstatement\u2019s date, speaker(s), and format (e.g., 10-K) (\u00b6\u00b662-\n\n 80), before detailing why each was materially false or misleading (\u00b681(a)-(f)).8\n\n Contrary to the Memo at 12, the threshold for \u00a710(b) actionability is not a\n\n \u201cstatement that was false when made.\u201d Instead: \u201cThe first step for a Rule 10b-5\n\n plaintiff is to establish that defendant made a materially false or misleading\n\n statement or omitted to state a material fact necessary to make a statement not\n\n misleading.\u201d In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1417 (3d\n\n Cir. 1997). Defendants also miscast the CAC\u2019s case theory, which is not a\n\n standalone duty to \u201cdisclose every detail\u201d of the Phase 2 Trial protocol, interim\n\n clinical details, anticipated FDA feedback, or \u201cevery risk inherent in drug\n\n development.\u201d Instead, in lockstep with black-letter law, the CAC pleads a duty to\n\n\n 8\n Defendants describe the CAC as a \u201cconfusing jumble\u201d that \u201cobfuscate[es] the\n facts.\u201d Memo at 7. Yet, Defendants had no trouble parsing and arguing that various\n statements or categories of statements were not adequately alleged as false.\n 16\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 25 of 50 PageID:\n 1937\n\n\n\n disclose omitted facts when disclosure was necessary to make Defendants\u2019\n\n statements, in the light of the circumstances under which they were made, not\n\n misleading. Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 37-38, 48 (2011).9\n\n Here, Defendants chose to speak (see \u00a7II, supra), and the omitted facts were\n\n material and rendered their statements misleading under the circumstances, e.g.: (i)\n\n the first Phase 2 Trial patient\u2019s TMA-related SAE; (ii) the ensuing dosing halt and\n\n root cause analysis; (iii) Rocket\u2019s effort to convince FDA a genetic predisposition\n\n was at fault and to alter the trial protocol to exclude other predisposed patients; (iv)\n\n the fourth Phase 2 Trial patient\u2019s TMA-related SAE; (v) the second ensuing dosing\n\n halt; (vi) the need to redesign the Phase 2 Trial protocol\u2019s complement suppression\n\n regimen with FDA approval; (vii) Rocket\u2019s decision to use the novel C3 inhibitor;\n\n (viii) the fifth and sixth Phase 2 Trial patients\u2019 CLS-related SAEs; and (ix) the\n\n inability to restart dosing while safely and effectively managing SAE risks.\n\n For example, Defendants actively discussed the first trial patient, saying, e.g.,\n\n he was \u201ctreated earlier, followed for a certain time, discussed with FDA and IDMC,\n\n and then we started the broader trial,\u201d without disclosing that he was \u201cfollowed\u201d to\n\n\n\n 9\n See also Cont\u2019l Gen. Ins. Co. v. Olafsson, 2024 WL 4263211, at *7 (D.N.J.\n Sep. 23, 2024) (same) (Quraishi, J.) (citing City of Edinburgh Council v. Pfizer, Inc.,\n 754 F.3d 159, 174 (3d Cir. 2014)); Williams v. Globus Med., Inc., 869 F.3d 235, 241\n (3d Cir. 2017) (\u201cOnce a company has chosen to speak on an issue\u2014even an issue it\n has no independent obligation to address\u2014it cannot omit material facts related to\n that issue so as to make its disclosure misleading.\u201d).\n 17\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 26 of 50 PageID:\n 1938\n\n\n\n monitor his acute kidney injury and extended hospitalization and \u201cdiscussed with\n\n FDA\u201d to determine the causes of his TMA-related SAE and its impacts on the Phase\n\n 2 Trial while dosing was halted and a root cause analysis was done. \u00b6\u00b69, 11, 68(b).\n\n These omissions made Defendants\u2019 statements materially misleading, when made,\n\n particularly given investor scrutiny on the Phase 2 Trial.\n\n Defendants\u2019 string-cited cases (Memo at 12-13) are either in harmony or are\n\n factually distinguishable. For instance, their case, Gregory v. ProNAi Therapeutics,\n\n Inc., agrees that \u201cthe failure to disclose protocol amendments can make affirmative\n\n statements about the success of a drug materially misleading,\u201d rejecting the claims\n\n only because, unlike Defendants here, \u201cProNAi made such disclosures\u201d insofar as\n\n \u201cthe vast majority of the protocol amendments at issue were promptly disclosed on\n\n the Clinical Trials website.\u201d 297 F. Supp. 3d 372, 410 (S.D.N.Y. 2018).10\n\n Defendants\u2019 lead case (Memo at 13-15, 27), City of Edinburgh, 754 F.3d at\n\n 159, does not counsel otherwise. After a company official said in 2006 that Phase 3\n\n testing would not proceed unless Phase 2 results were \u201cspectacular\u201d (which the court\n\n\n\n 10\n Similarly, unlike here, \u201cmuch of the information conveyed to Sanofi by the\n FDA was publicly available\u201d in In re Sanofi Sec. Litig., 87 F. Supp. 3d 510, 539\n (S.D.N.Y. 2015), and defendants \u201cpromptly disclosed\u201d FDA\u2019s concerns and need\n for more studies in Johnson v. Pozen, Inc., 2009 U.S. Dist. LEXIS 12765 (M.D.N.C.\n Feb. 19, 2009). Defendants\u2019 other cases are distinguishable and involved failure to\n disclose some aspect of trial testing methodology, e.g., misleading assumptions in\n calculating a secondary endpoint (Hoey), unsound statistical analysis and deviations\n from protocol methods (MELA), or use of a multiple-dose study (Fort Worth).\n 18\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 27 of 50 PageID:\n 1939\n\n\n\n said was puffery), a May 2007 press release disclosed the decision to \u201cinitiate\u201d a\n\n Phase 3 program, and said, \u201cNo conclusion about the Phase 2 study can be drawn\n\n until the study is completed and the final data are analyzed and released in 2008.\u201d\n\n Id. at 164, 171. The company otherwise chose not to speak about Phase 2 results.\n\n Id. at 169. The May 2007 press release \u201cmade no statement about the strength of\n\n interim results\u201d or the drug\u2019s \u201cefficacy or safety,\u201d and later statements were \u201cvague,\u201d\n\n \u201cnon-specific,\u201d or consistent with the May 2007 press release. Id. at 168, 170, 172-\n\n 173. Having \u201cmade no affirmative statement about the strength of the Phase 2\n\n interim results nor characterized those results in any manner,\u201d the results were not\n\n \u201cin play\u201d and \u201cno duty to provide additional details about those results\u201d arose. Id.\n\n at 174. Thus, the claims were dismissed, despite a later revelation that Phase 2\n\n \u201cfailed to meet its objectives\u201d and had \u201cserious safety concerns.\u201d Id. at 165, 169.\n\n By contrast, here, Defendants chose to speak, at length and repeatedly,\n\n regarding the Phase 2 Trial. See \u00a7II, supra. They discussed the first patient\u2019s dosing,\n\n post-dosing monitoring, and related discussions with FDA, while concealing his\n\n TMA-related SAE and the trial impacts therefrom. Throughout the Class Period,\n\n Defendants also regularly touted the Phase 2 Trial\u2019s \u201clow dose\u201d and \u201cadditional\n\n safety measures,\u201d including the \u201crefined immunomodulatory regimen,\u201d that were all\n\n implemented \u201cto mitigate the complement-mediated safety concerns identified in the\n\n high dose [Phase 1] cohort (thrombotic microangiopathy (\u2018TMA\u2019)).\u201d \u00b6\u00b662(a)-(b).\n\n 19\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 28 of 50 PageID:\n 1940\n\n\n\n They continued doing so even after multiple TMA-related SAEs, prompting dosing\n\n halts, a root cause analysis, trial redesigns, a decision to employ a novel C3 inhibitor,\n\n and the need to lobby FDA for approvals to proceed. Their statements brought the\n\n Phase 2 Trial dosing efforts, safety measures, and complement activation\n\n suppression regimen \u201cin play\u201d in the way City of Edinburgh noted could happen\n\n when companies choose to speak. See, e.g., Levon v. CorMedix Inc., 797 F. Supp.\n\n 3d 381, 407 (D.N.J. 2025) (discussion of FDA approval timeline \u201ccreated a parallel\n\n duty to disclose the issues at ROVI\u2019s facility impeding the proscribed timeline\u201d).11\n\n Defendants\u2019 other arguments fail. First, misstatements can be actionable\n\n without being a \u201cblanket statement\u201d about \u201csafety,\u201d \u201ccertainty of outcome,\u201d or\n\n \u201ccertainty of timeline\u201d (Memo at 16, 21).12 See, e.g., Frater v. Hemispherx\n\n Biopharma, Inc., 996 F. Supp. 2d 335, 348-349 (E.D. Pa. 2014) (rejecting argument\n\n that statements are inactionable because they \u201cnever made guarantees or assurances\u201d\n\n\n 11\n See also In re Celgene Corp. Sec. Litig., 2019 WL 6909463, at *18 (D.N.J.\n Dec. 19, 2019) (telling investors \u201cpositive clinical study results\u201d without disclosing\n discovery of a metabolite that altered safety and efficacy profile and required more\n testing was misleading); Industriens Pensionsforsikring A/S v. Becton, Dickinson &\n Co., 620 F. Supp. 3d 167, 186 (D.N.J. 2022) (saying company \u201cin discussions with\n the FDA\u201d about software upgrades actionable for omitting that FDA found company\n had failed to fix software problems and demanded a product ship hold; \u201cdefendants\n may not describe \u2018a favorable picture\u2019 of material issue \u2018without including the details\n that would have presented a complete and less favorable one\u2019\u201d).\n 12\n Defendants claim Rocket never \u201cmade any representation or guarantee of final\n success in the clinical trials.\u201d Memo at 22. The CAC\u2019s claims, however, do not\n concern final FDA approval of A501, which it never discusses. The fraud concerns\n the Phase 2 Trial itself and meets the pleading standard for securities fraud.\n 20\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 29 of 50 PageID:\n 1941\n\n\n\n about an NDA\u2019s success as \u201cirrelevant to whether Hemispherx systemically misled\n\n investors about the key components of the [] NDA\u201d).\n\n Second, as noted in \u00a7II, supra, the NEJM article (not properly before the\n\n Court) does not undermine falsity (Memo at 16, 22), both because it concerned Phase\n\n 1 TMA issues that the Phase 2 Trial had purportedly been designed to address, and\n\n because it was published nine months into the Class Period \u2013 after many\n\n misstatements and both TMA-related SAEs in Phase 2 had occurred.\n\n Third, Defendants made statements of fact (Memo at 17) \u2013 i.e., describing the\n\n Phase 2 Trial\u2019s dosage, complement activation suppression regimen, and safety\n\n features; describing the dosing, monitoring, and FDA communications about the two\n\n safety run-in patients; updating on patient enrollment, dosing, and follow-up; and\n\n attributing trial delays to benign reasons and not SAEs / related setbacks. Declaring\n\n those statements immaterial fails, especially viewed in the context of Phase 1 issues.\n\n See, e.g., Whiteley v. Zynerba Pharms., Inc., 2020 WL 13879653, at *1 n.1 (E.D. Pa.\n\n Nov. 25, 2020) (statements describing phase 2 trial, including that patients \u201care\n\n being dosed,\u201d actionable where \u201cDefendants knew but failed to disclose that almost\n\n all patients enrolled in the [] trial suffered treatment emergent adverse events\u201d). 13\n\n\n 13\n See also City of Livonia Emps.\u2019 Ret. Sys. v. Wyeth, 2010 WL 3910265, at *5-\n 7 (S.D.N.Y. 2010) (complaint sufficiently pled duty to disclose SAEs in study after\n defendants made safety-related statements excluding SAEs); SEB Inv. Mgmt. AB v.\n Endo Int\u2019l, PLC, 351 F. Supp. 3d 874, 903-904 (E.D. Pa. 2018) (significant stock\n drop after revelation of facts about drug\u2019s lack of safety and abuse-deterrent\n 21\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 30 of 50 PageID:\n 1942\n\n\n\n SEC filings (Memo at 17-19).14 Arguing Rocket\u2019s 10-K and 10-Q statements\n\n during the Class Period were not false or misleading, Defendants excerpt parts that\n\n repeatedly: (a) tout measures adopted in the Phase 2 Trial to \u201cmitigate complement-\n\n mediated safety concerns observed in the high dose cohort\u201d of Phase 1, and (b) say\n\n Phase 2 Trial patient \u201cdosing and follow-up is ongoing.\u201d These statements omitted\n\n material facts necessary to make them, under the circumstances, not misleading, e.g.,\n\n the two TMA-related SAEs, initial dosing halt, root cause analysis, and trial redesign\n\n to add the novel C3 inhibitor which further delayed the trial.15 See, e.g., Whiteley,\n\n 2020 WL 13879653, at *1 n.1 (statements that patients \u201care being dosed\u201d actionable\n\n where defendants knew almost all patients suffered treatment emergent adverse\n\n events); Levon, 797 F. Supp. 3d at 406-09 (\u201cstatements regarding the timeline for\n\n FDA approval\u201d \u2013 e.g.\u00b8 NDA was \u201con track,\u201d approval was \u201con schedule\u201d \u2013 \u201ccreated\n\n a parallel duty to disclose [issues] impeding the proscribed timeline\u201d). Defendants\u2019\n\n August 7, 2025 statements discussed prior SAEs and efforts at \u201cregulatory\n\n alignment\u201d while concealing that Rocket lacked any viable approach to safely dose\n\n\n\n properties demonstrate materiality); Levon, 797 F. Supp. 3d at 407 (materiality\n evidenced by allegations of subsequent disclosure and significant impact on market).\n 14\n The Memo ignores certain types of filings (Forms 8-K, Annual Reports, etc.).\n 15\n As noted in \u00a7I, supra, Defendants wrongly blur Rocket\u2019s past tense statements\n that \u201cadditional safety measures have been implemented\u201d in the Phase 2 Trial\n protocol into future-looking rewrites that it was \u201cimplementing\u201d or \u201cincorporating\u201d\n safety measures (e.g., Memo at 18-19) in some open-ended way that would render a\n trial redesign to add the novel C3 inhibitor insignificant and expected. Not so.\n 22\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 31 of 50 PageID:\n 1943\n\n\n\n patients while effectively managing SAE risks. Johnston v. HBO Film Mgmt., Inc.,\n\n 265 F.3d 178, 193 (3d Cir. 2001) (\u201cStatements which are technically true may be so\n\n incomplete as to be misleading (e.g., half-truths or distortions).\u201d).\n\n Press Releases (Memo at 20-22).16 Defendants\u2019 claim of \u201cgeneralized, vacant\n\n allegations\u201d is false. The CAC has six pages of detailed allegations (see \u00b681(a)-(f))\n\n explaining why every misstatement was materially false or misleading when made.\n\n Those allegations and the detail with which each alleged misstatement is pled satisfy\n\n the applicable pleading standards. Avaya, 564 F.3d at 253. Defendants otherwise\n\n summarize snippets of larger statements as mere \u201cperiodic updates,\u201d e.g., \u201cDosing\n\n in the Phase 2 pivotal study is ongoing\u201d (\u00b667) or \u201cThe pediatric run-in enrolled two\n\n patients in a sequential manner with a minimum three-month follow-up prior to\n\n subsequent enrollment\u201d (\u00b666). Here, too, having chosen to speak, Defendants had a\n\n duty to disclose information \u2013 the TMA-related SAEs and their impacts \u2013 needed to\n\n make the statements made, under the circumstances, not misleading. Matrixx, 563\n\n U.S. at 37-38, 48; Olafsson, 2024 WL 4263211, at *7; Whiteley, 2020 WL\n\n 13879653, at *1 n.1; Wyeth, 2010 WL 3910265, at *5-7; Levon, 797 F. Supp. 3d at\n\n\n 16\n Defendants miscast several pre-Class Period press releases from 2019-2023,\n pled in CAC \u00a7V.A. (\u201cRocket\u2019s Business & Operations\u201d) \u00b6\u00b636, 40, 42, as\n misstatements (Memo at 20) and miscast the 5/27/2025 Press Release (discussed in\n \u00b653) as a misstatement. To the contrary, all misstatements are alleged in CAC \u00a7V.C.\n (\u00b6\u00b661-81). Without explanation, Defendants also quote \u201cpipeline\u201d and \u201cstrong\n progress\u201d language from the 2/27/2025 Earnings Release (Memo at 21-22, 27) that\n is not part of the misstatement as pled in the CAC. \u00b673(a).\n 23\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 32 of 50 PageID:\n 1944\n\n\n\n 406-09; Celgene, 2019 WL 6909463, at *18; Becton, 620 F. Supp. 3d at 186. Again,\n\n \u201cblanket statements\u201d are not needed actionability. Frater, 996 F. Supp. 2d at 348-\n\n 349. The 8/7/2025 Earnings Release and 8/20/2025 Press Release, issued after the\n\n CLS-related SAEs and patient death, were materially misleading for omitting the\n\n material fact that Rocket lacked a viable approach that could address the SAE issues\n\n from the Phase 1 trial, dose A501 at levels sufficient to conduct adequate Phase 2\n\n clinical testing, and ensure Phase 2 Trial patient safety. \u00b681(f). Indeed, despite\n\n FDA\u2019s clinical hold lifting in August 2025, no more patients have been dosed. \u00b6103.\n\n Webinars & Conferences (Memo at 22-23). Contrary to Defendants\u2019 out-of-\n\n context snippets, the alleged webinar and conference misstatements are robust. For\n\n instance, \u201cAnd then we had a two-patient run-in, right, and the patients had to be\n\n staggered too. And then after the second patient, there\u2019s another follow-up period.\n\n And then you talk to the FDA again.\u201d \u00b665. In September 2024, after both TMA-\n\n related SAEs, that statement discussed dosing, follow-up monitoring, and FDA\n\n discussions for the two-patient safety run-in, which included the first trial patient,\n\n who suffered an undisclosed TMA-related SAE, prompting a dosing halt, root cause\n\n analysis, FDA discussions, and trial modification. Still later, Defendants said \u201cwe\u2019re\n\n in the process of dosing, and we are dosing patients\u201d at a November 12, 2024\n\n conference (\u00b668(a)), \u201cWe\u2019re continuing to dose patients\u201d at a December 3, 2024\n\n conference (\u00b670(a)), and \u201cWe\u2019re finishing dosing as fast as possible\u201d on January 13,\n\n 24\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 33 of 50 PageID:\n 1945\n\n\n\n 2025 (\u00b672) \u2013 when all dosing was halted, following the second TMA-related SAE\n\n earlier in 2024 and pending the later C3 inhibitor addition. Multiple times (e.g.,\n\n December 3, 2024 (\u00b670(b) and April 8, 2025 (\u00b674)) Defendants attributed trial delays\n\n to benign reasons, like the \u201cheavy protocol,\u201d necessary patient \u201cstaggering,\u201d or the\n\n holidays, when the reality was that dosing was halted. Each time, the omitted facts\n\n rendered the statement materially misleading. Matrixx, 563 U.S. at 37-38, 48;\n\n Olafsson, 2024 WL 4263211, at *7; Whiteley, 2020 WL 13879653, at *1 n.1; Wyeth,\n\n 2010 WL 3910265, at *5-7; Levon, 797 F. Supp. 3d at 406-09; Celgene, 2019 WL\n\n 6909463, at *18; Becton, 620 F. Supp. 3d at 186.\n\n C. THE MISSTATEMENTS AND OMISSIONS ARE NOT\n PROTECTED FROM LIABILITY\n Also unavailing are Defendants\u2019 \u201cprotected forward-looking statements\u201d\n\n arguments relying on: (i) purported \u201ccautionary language\u201d and the PSLRA safe\n\n harbor, (ii) the bespeaks caution doctrine, and/or (iii) statements being \u201copinions.\u201d\n\n See Memo at 23-32. The CAC plainly pleads why neither the PSLRA safe harbor\n\n nor the bespeaks caution doctrine apply to any alleged misstatement. \u00b6\u00b6119-122.\n\n First, as Defendants concede (Memo at 24), the PSLRA safe harbor only\n\n applies to forward-looking statements. 15 U.S.C. 78u-5(c). Defendants fatally fail\n\n to identify which if any misstatements, or portions thereof, are purportedly\n\n \u201cforward-looking,\u201d declaring instead, without citation, that entire categories of\n\n statements \u2013 e.g., \u201cdosing progress\u201d or \u201cregulatory interactions\u201d \u2013 qualify. Memo at\n 25\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 34 of 50 PageID:\n 1946\n\n\n\n 23. The CAC misstatements (see \u00a7II, supra) say otherwise. Those describing the\n\n Phase 2 Trial protocol,17 discussing the first two dosed patients,18 touting progress\n\n in dosing trial patients,19 attributing trial delays to benign reasons,20 and, after a\n\n patient died, downplaying the TMA-related SAEs21 and expressing confidence and\n\n commitment to restarting the trial22 were all past- and/or present-tense statements\n\n\n\n 17\n E.g., \u201cwe have moved forward with the low dose\u201d and \u201cadditional safety\n measures have been implemented and are reflected in the updated trial protocol.\u201d\n \u00b6\u00b68, 62(a)-(b).\n 18\n E.g., \u201cThe pediatric run-in enrolled two patients in a sequential manner with\n a minimum three-month follow-up prior to subsequent enrollment,\u201d \u201ctwo patients\n were treated earlier, followed for a certain time, discussed with FDA and IDMC, and\n then we started the broader trial,\u201d and \u201cwe had a two-patient run-in, right, and the\n patients had to be staggered too. And then you talk to the FDA again.\u201d \u00b6\u00b69, 11, 65,\n 66, 68(b), 79(b).\n 19\n E.g., \u201cwe\u2019re finishing dosing as fast as possible,\u201d \u201cdosing and follow-up are\n ongoing,\u201d and \u201cthe trial and follow-up are ongoing.\u201d \u00b6\u00b610, 72, 73(b), 77.\n 20\n E.g., \u201cNumber one, these patients require immunomodulation. So, that takes\n time to set up and source appropriately. Number two, there\u2019s some vaccines\n involved in immunomodulation, which also takes time. There\u2019s a troponin run-in,\n number three, of three months that the FDA mandates.\u2026 [I]nstead of putting\n everyone at one site, we try to stagger them. So, that takes a little bit of time.\u2026 So,\n all this, along with the holidays, has added the time up, which I understand is not\n ideal, but it is getting done.\u201d \u00b6\u00b611, 65, 68(b), 70(b), 74.\n 21\n E.g., the complement activation and TMA \u201cwas part of routine explained side\n effects of gene therapy\u201d with \u201cno clinical hold.\u201d \u00b6\u00b678(b), 79(b).\n 22\n E.g., \u201cwe remain committed to advancing RP-A501 with the highest standards\n of safety, science, and care,\u201d \u201cwe\u2019re confident that there is a path forward with the\n simplified regimen here,\u201d \u201cRocket is actively working with FDA, independent safety\n monitors, and clinical experts to ensure patient safety and resume the trial,\u201d \u201cWe\u2019re\n already in deep dialogue with FDA back and forth\u2026discussing with them a potential\n revising immunomodulatory regimen and potentially other changes\u201d and \u201cThe hold\n was lifted in under three months, underscoring\u2026Rocket\u2019s commitment to\n expeditiously optimize safety and resume the trial.\u201d \u00b6\u00b678(a), 78(c)-(e), 79(a), 80.\n 26\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 35 of 50 PageID:\n 1947\n\n\n\n discussing then-existing facts. Defendants point to no misstatements that fall within\n\n the PSLRA safe harbor examples they cite \u2013 \u201cfuture economic performance,\u201d \u201cfuture\n\n operations,\u201d or \u201cplans or objectives.\u201d Memo at 24 (citing 15 U.S.C. 78u-5(i)(1)).\n\n The PSLRA safe harbor does not protect statements about present facts, even\n\n if part of mixed present / future statements. Carmignac Gestion, S.A. v. Perrigo Co.\n\n PLC, 2019 WL 3451523, at *11 (D.N.J. July 31, 2019) (safe harbor does not apply\n\n where plaintiffs sufficiently allege defendants omitted present facts from challenged\n\n statements); Olafsson, 2024 WL 4263211, at *11 (\u201cA mixed present/future statement\n\n is not entitled to the safe harbor with respect to the part of the statement that refers\n\n to the present.\u201d (quoting Avaya, 564 F.3d at 255)).23 Defendants\u2019 authority concurs.\n\n See Iowa Pub. Emps.\u2019 Ret. Sys. v. MF Glob., Ltd., 620 F.3d 137, 141 (2d Cir. 2010)\n\n (bespeaks caution doctrine not applicable to present or historical fact).24\n\n Second, as the CAC pled, many misstatements were not identified as forward-\n\n looking and accompanied by any risk warnings.25 Those misstatements are\n\n\n 23\n See also In re Dr. Reddy\u2019s Lab\u2019y Ltd. Sec. Litig., 2019 WL 1299673, at *18\n (D.N.J. Mar. 20, 2019) (merely containing \u201csome reference to a projection of future\n events\u201d does not bring statement within PSLRA safe harbor \u201cif the allegation of\n falsehood relates to non-forward-looking aspects of the statement\u201d).\n 24\n Their other cases (Memo at 23-25) involved forward-looking statements, e.g.,\n when a company expected to file a future NDA and when it could expect FDA\n approval (Gillis), prospects of future FDA approval (Lewakowski), expected future\n investment losses (Slayton), and future ability to repay bonds (Donald J. Trump).\n 25\n See \u00b664 (5/16/2024 BoA Conference); \u00b665 (9/5/2024 MS Conference); \u00b668\n (11/12/2024 UBS Conference); \u00b670 (12/3/2024 Evercore Conference); \u00b674\n (4/8/2025 Needham Conference).\n 27\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 36 of 50 PageID:\n 1948\n\n\n\n ineligible for safe harbor protection. 15 U.S.C. 78u-5(c)(1)(A)(i).\n\n Third, forward-looking statements must be accompanied by \u201cmeaningful\n\n cautionary statements identifying important factors that could cause results to differ\n\n materially from those in the forward-looking statement,\u201d and \u201c[c]autionary language\n\n must be extensive and specific.\u201d Avaya, 564 F.3d at 256 (quoting, inter alia, 15\n\n U.S.C. \u00a778u-5(c)(1)(A)(i)). The purported \u201ccautionary language\u201d Defendants quote\n\n (Memo at 16, 18-19, 25-32) is legally deficient, for any or all of four reasons:\n\n (i) Certain purported warnings were generic and boilerplate.26 \u201cA vague\n\n or blanket (boilerplate) disclaimer which merely warns the reader that the investment\n\n has risks will ordinarily be inadequate to prevent misinformation.\u201d Avaya, 564 F.3d\n\n at 256; see also Shulman v. Weston, 2025 WL 3754159, at *8 (D.N.J. Dec. 29, 2025)\n\n (generic language regarding risk of relying on forward-looking statements is\n\n boilerplate warning insufficient to correct a reasonable investor\u2019s risk calculations).\n\n (ii) Certain purported warnings were not tailored to the alleged\n\n\n 26\n E.g., Warnings like \u201cinvesting in our securities involves a high degree of risk,\u201d\n \u201cour business is subject to numerous risks and uncertainties,\u201d \u201cThis press release\n contains forward-looking statements concerning Rocket\u2019s future expectations, plans\n and prospects that involve risks and uncertainties, as well as assumptions that, if they\n do not materialize or prove incorrect, could cause our results to differ materially\n from those expressed or implied,\u201d \u201cStatements made during today\u2019s webinar and our\n responses during the Q&A may include forward-looking statements\u2026subject to\n known and unknown risks and uncertainties that may cause actual results to differ\n materially from the statements made,\u201d \u201cActual results may differ materially from\n those indicated by these forward-looking statements as a result of various important\n factors\u2026.\u201d Memo at 18-19, 28-29, 30-32.\n 28\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 37 of 50 PageID:\n 1949\n\n\n\n misstatements and omissions, concerning the Phase 2 Trial, its SAEs, and related\n\n trial impacts, as versus any \u201cexpectations.\u201d27 \u201cTo suffice, the cautionary statements\n\n must be substantive and tailored to the specific future projections, estimates or\n\n opinions in the prospectus which the plaintiffs challenge.\u201d Avaya, 564 F.3d at 256;\n\n Levon, 797 F. Supp. 3d at 411 (same for PSLRA and bespeaks caution doctrine).\n\n (iii) As Defendants concede, certain purported warnings did not adjust over\n\n time, being repeated in substantially similar fashion throughout the Class Period\n\n despite evolving circumstances rendering them outdated. See Memo at 16, 26\n\n (discussing Forms 10-K and ARS). In re Hertz Glob. Holdings, Inc. Sec. Litig., 2017\n\n WL 1536223, at *15 (D.N.J. Apr. 27, 2017) (\u201c[T]he fact that the vague cautionary\n\n language never changed strongly suggests that it was not tailored to the specific\n\n future projection.\u201d), aff\u2019d, 905 F.3d 106 (3d Cir. 2018).28\n\n (iv) Certain purported warnings concerned already-occurred events.29\n\n\n 27\n E.g., Rocket \u201cmay fail to demonstrate safety and efficacy\u2026 which could\n prevent us from commercializing our current and future product candidates,\u201d \u201cour\n product candidates may cause undesirable and unforeseen side effects\u2026which\n could\u2026limit the commercial potential,\u201d and \u201cforward-looking statements\n include\u2026expectations regarding the safety and effectiveness of product candidates\n that Rocket is developing to treat\u2026Danon Disease\u2026, the expected timing\u2026of\n Rocket\u2019s ongoing and planned clinical trials,\u2026the safety, effectiveness, and timing\n of\u2026clinical trials.\u201d Memo at 18, 25, 29, 31.\n 28\n See also In re Innocoll Holdings Pub. Ltd. Sec. Litig., 2020 WL 1479128, at\n *17-18 (E.D. Pa. March 25, 2020) (\u201c[T]he cautionary language\u2026did not change\n from 2014 to 2016. Therefore, the Court finds that the PSLRA\u2019s \u2018Safe Harbor\u2019\n provision does not apply to any of Defendants\u2019 statements.\u201d).\n 29\n E.g., \u201cour business is subject to numerous risks and uncertainties\u201d including\n 29\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 38 of 50 PageID:\n 1950\n\n\n\n Levon, 797 F. Supp. 3d at 411 (\u201cCautionary statements are not truly cautionary when\n\n the defendant knows that an identified risk has or will occur.\u201d); Becton, 620 F. Supp.\n\n 3d at 189, 191 (rejecting the purported cautionary language as not meaningful and\n\n stating, \u201cCautionary words about future risk cannot insulate from liability the failure\n\n to disclose that the risk has transpired\u201d).\n\n Defendants\u2019 untethered \u201copinions\u201d argument (Memo at 27-28, 30, 35) fails.\n\n First, they fail to identify which misstatements they consider opinions, and their only\n\n example (a statement about the Phase 1 trial\u2019s \u201cstrong progress\u201d) is not pled as a\n\n misstatement.30 To the contrary, the CAC challenges statements of facts, not\n\n opinions, e.g., \u201cdosing and follow-up are ongoing\u201d or \u201ctwo patients were treated\n\n earlier, followed for a certain time, discussed with FDA and IDMC, and then we\n\n started the broader trial.\u201d Prudential, 70 F.4th at 684 (\u201c[A]n opinion is a belief, a\n\n\n\n \u201csubstantial delays in\u2026completion of our clinical trials,\u201d \u201c[g]ene therapy is still a\n relatively new approach to disease treatment and adverse side effects could develop\n with our product candidates,\u201d \u201c[i]f certain side effects are observed in testing of our\n potential product candidates, we may decide or be required to halt or delay further\n clinical development,\u201d \u201c[o]ur product candidates may cause undesirable and\n unforeseen side effects\u2026which could delay or prevent their advancement into\n clinical trials,\u201d and \u201cthe administration process or related procedures associated with\n a given product candidate also can cause adverse side effects. If any such adverse\n events occur, our clinical trials could be suspended.\u201d Memo at 18, 25-26.\n 30\n Even their case law examples (Memo at 27-28, 35) are facially inapposite, as\n the CAC does not plead any misstatements claiming anything was \u201cencouraging\u201d\n (Kleinman and Sanofi), regarding anticipated commercialization dates (Ocugen and\n Aratana), or involving interpretation of clinical trial data (Sanofi, City of Edinburgh,\n Gillis) or the strength of patents being litigated (Dang).\n 30\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 39 of 50 PageID:\n 1951\n\n\n\n view, or a sentiment which the mind forms of persons or things, whereas a fact is a\n\n thing done or existing or an actual happening.\u201d (quoting Omnicare, Inc. v. Laborers\n\n Dist. Council Constr. Indus. Pension Fund, 575 U.S. 175, 183 (2015))).\n\n Even assuming, arguendo, some misstatements were opinions, they are\n\n actionable if \u201c(1) the speaker did not actually hold the stated belief at the time made;\n\n (2) the opinion contains \u2018embedded statements of fact\u2019 that were untrue; or (3) the\n\n speaker omitted known material facts that \u2018conflict with what a reasonable investor\n\n would take from the statement itself.\u2019\u201d In re Advance Auto Parts, Inc. Sec. Litig.,\n\n 2020 WL 599543, at *4 (D. Del. Feb. 7, 2020) (quoting Omnicare, 575 U.S. at 184);\n\n Levon, 797 F. Supp. 3d at 414. All three tests are met here. Defendants knowingly\n\n omitted material facts, e.g., about the TMA-related SAEs and resulting trial impacts.\n\n Thus, even if statements are opinions, they are actionable.\n\n Also meritless is Defendants\u2019 argument calling the alleged misstatements\n\n \u201cfraud by hindsight.\u201d Memo at 4, 29. All alleged misstatements are pled in detail as\n\n materially false or misleading when made \u00b6\u00b681(a)-(f), which Defendants ignore.31\n\n D. THE CAC ADEQUATELY PLEADS SCIENTER\n\n Scienter allegations must be read \u201cholistically.\u201d Tellabs, Inc. v. Makor Issues\n\n\n\n 31\n Defendants do not identify a specific \u201cfraud by hindsight\u201d misstatement, and\n neither of their cases, Cozzarelli and NAHC, use that term. Defendants merely quote\n dicta regarding analysis of motive scienter pleading (Cozzarelli) or nondisclosure of\n a loss that had not yet occurred (NAHC).\n 31\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 40 of 50 PageID:\n 1952\n\n\n\n & Rts., Ltd., 551 U.S. 308, 310, 326 (2007). \u201cThe inquiry\u2026is whether all of the\n\n facts alleged, taken collectively, give rise to a strong inference of scienter, not\n\n whether any individual allegation, scrutinized in isolation, meets that standard. Id.\n\n at 322-323 (emphasis original). The inference \u201cneed not be irrefutable, i.e., of the\n\n \u2018smoking-gun\u2019 genre, or even the \u2018most plausible of competing inferences.\u2019\u201d Id. at\n\n 324. Rather, after weighing the \u201cinferences urged by the plaintiff\u201d with \u201ccompeting\n\n inferences rationally drawn from the facts alleged,\u201d id. at 314, \u201cthe reviewing court\n\n must ask: When the allegations are accepted as true and taken collectively, would a\n\n reasonable person deem the inference of scienter at least as strong as any opposing\n\n inference?\u201d Id. at 326; see also Matrixx, 563 U.S. at 38, 48 (scienter adequately pled\n\n if \u201ca reasonable person would deem the inference\u2026cogent and at least as compelling\n\n as any opposing inference\u201d). Where, as here, motive and opportunity is alleged, the\n\n scienter pleading burden is more easily met. Rahman v. Kid Brands, Inc., 736 F.3d\n\n 237, 245 (3d Cir. 2013) (\u201cThough it is not necessary to plead motive to establish that\n\n a defendant acted with scienter, its presence can be persuasive when conducting a\n\n holistic review of the evidence.\u201d).\n\n Accordingly, unless Defendants proffer a more compelling inference,\n\n rationally drawn from the CAC\u2019s allegations, their Motion must be rejected \u2013 as they\n\n concede (Memo at 12, 33). If the parties\u2019 competing inferences are in equipoise, the\n\n CAC must be upheld. See, e.g., City of Pontiac Gen. Emps.\u2019 Ret. Sys. v. Lockheed\n\n 32\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 41 of 50 PageID:\n 1953\n\n\n\n Martin Corp., 875 F. Supp. 2d 359, 372 (S.D.N.Y. 2012) (\u201cAt the motion to dismiss\n\n stage a tie on scienter goes to the plaintiff.\u201d (citing Tellabs, 551 U.S. at 314)).\n\n The CAC pleads a strong inference of scienter, supported by extensive factual\n\n allegations. See CAC \u00a7V.E.1.-7. (\u00b6\u00b694-118); \u00a7II, supra. Defendants, knowingly or\n\n with deliberate recklessness, misrepresented and omitted material adverse facts\n\n causing their public statements during the Class Period about the Phase 2 Trial and\n\n its true risk profile to be materially false or misleading.32 The CAC pleads\n\n Defendants\u2019 knowledge or reckless disregard of such facts making their statements\n\n false or misleading when made. \u00b6\u00b698-103. It pleads their motive and opportunity,\n\n based on Rocket\u2019s $182.5 million corporate offering and stock sales by Defendants\n\n Shah and Ondrey, all at fraud-inflated prices, suspicious in timing and amount.\n\n \u00b6\u00b695-97; see also Appendix A submitted herewith. It adds allegations that support\n\n the scienter inference, including implication of the core operations doctrine (\u00b6\u00b6104-\n\n 106); Shah\u2019s and Ondrey\u2019s signing, being quoted in, and SOX-certifying Rocket\u2019s\n\n\n\n 32\n Specifically: (i) the Phase 2 Trial was beset by a TMA-related SAE due to\n A501 (Patient #1), an ensuing dosing halt and root cause analysis, work to persuade\n FDA to permit resumption after excluding patients with a genetic predisposition,\n another TMA-related SAE due to the complement suppression regimen (Patient #4),\n an ensuing dosing halt and decision to switch to the C3 inhibitor, work to persuade\n FDA to permit a trial redesign, then two CLS-related SAEs (Patients #5 and #6) due\n to the C3 inhibitor, causing one patient death, a trial hold, and a cessation of dosing;\n and (ii) throughout the Class Period, Rocket had no viable approach or trial design\n that could safely and effectively dose patients with A501 while managing the trial\u2019s\n SAE risks. \u00b6\u00b66-7, 47, 81(a)-(f), 98-103.\n 33\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 42 of 50 PageID:\n 1954\n\n\n\n allegedly fraudulent SEC filings (\u00b6\u00b6107-108); suspicious resignations of key Rocket\n\n officers and directors, including Defendant Ondrey (\u00b6\u00b6109-114); and violations of\n\n Rocket\u2019s Corporate Code of Conduct and Insider Trading Policy (\u00b6\u00b6115-118).\n\n As Lead Plaintiffs\u2019 MTD Letter response noted (ECF 36 at 3), Defendants\n\n offer no competing inference rationally drawn from the CAC\u2019s allegations, a\n\n deficiency that requires denial of their Motion since dismissal is possible only if\n\n Defendants\u2019 inference is more compelling than the one pled in the CAC. Tellabs,\n\n 551 U.S. at 322-324; Matrixx, 563 U.S. at 48. Instead, they rewrite the CAC\u2019s theory\n\n and argue against their strawman, critiquing the CAC for, e.g., (i) not pleading they\n\n had actual knowledge the C3 inhibitor would harm patients (ii) pleading \u201cno facts\n\n suggesting Rocket believed this addition would harm patients,\u201d and (iii) inferring\n\n Rocket would \u201cknowingly introduce a component it anticipated would jeopardize\n\n patient safety and undermine the very trial upon which the future of its experimental\n\n treatment depended.\u201d Memo at 33-34. Those \u201cdoomed to failure\u201d arguments might\n\n apply to a breach of duty case, not the securities fraud claims as pled in the CAC.33\n\n Defendants otherwise challenge aspects of the CAC\u2019s scienter pleading, in\n\n isolation, counter to the required Tellabs holistic analysis. Their arguments fail.\n\n\n 33\n In Defendants\u2019 cases (Memo at 33-35), no suspicious stock sales prompted\n the court to credit competing inferences that defendants fully disclosed disappointing\n phase 2 trial results and their phase 3 redesign to use a different comparator drug\n based on a public study the court found they \u201creasonably relied\u201d on (Kelley) or that\n they believed trial results supported FDA approval (Lewakowski and Cozzarelli).\n 34\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 43 of 50 PageID:\n 1955\n\n\n\n Knowledge / Recklessness (Memo at 34-35, 37-38). The CAC pleads, inter\n\n alia: (i) pursuant to 21 C.F.R. \u00a7312.64, all SAEs were required to be, and were,\n\n immediately reported to Defendants (\u00b6\u00b698-99); (ii) CWs and Rocket\u2019s later\n\n admissions demonstrate Defendants\u2019 knew about SAE #1 in early 2024 and SAE #2\n\n in August 2024, decided to add the C3 inhibitor in January 2025, and knew of SAEs\n\n #3 and 4 once dosing resumed in May 2025 (\u00b6\u00b6100-101); (iii) Rocket\u2019s C-suite,\n\n including Defendants Shah and Ondrey, were heavily involved in the A501 program,\n\n including dosing halts, root cause analyses, and FDA discussions and non-\n\n resumption of the Phase 2 Trial (\u00b6\u00b6102-103).34 These are factual allegations, not\n\n legal conclusions, rendering Defendants\u2019 cases (GSC and Ashcroft) inapposite. The\n\n same facts adequately plead Defendants\u2019 deliberate recklessness, in harmony with\n\n Defendants\u2019 citations. See, e.g., Novak v. Kasaks, 216 F.3d 300, 308, 311 (2d Cir.\n\n 2000) (recklessness sufficient where complaint pled defendants \u201cknew facts or had\n\n access to information suggesting that their public statements were not accurate\u201d).35\n\n That FDA approved the C3 inhibitor (Memo at 38) is a non-sequitur. The fraud,\n\n concerning the C3 inhibitor, arises not just from its addition, but also from\n\n\n\n 34\n Defendant mischaracterize CAC \u00b6143, whose next sentence (which they omit)\n states, \u201cDefendants\u2019 first-hand knowledge is alleged herein.\u201d\n 35\n Defendants\u2019 other cases do not counsel dismissal, as they involved defendants\n that engaged in mismanagement (Digit. Island), failed to investigate but lacked\n knowledge of negative facts (S. Cherry), or acted only negligently, lacking motive\n and opportunity, and offered more compelling nonculpable inferences (Radian).\n 35\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 44 of 50 PageID:\n 1956\n\n\n\n concealing the preceding SAEs, dosing halts, FDA negotiations, and trial redesign.\n\n Motive \u2013 Stock Sales (Memo at 35-36). The CAC pleads that Defendants\u2019\n\n Class Period sales of stock at fraud-inflated prices were suspicious in both amount\n\n (compared to their salaries) and timing. \u00b695(a)-(b); see Appendix A (aligning sales\n\n with misstatements, corrective disclosures, and key events). Sidestepping these\n\n allegations,36 Defendants: (i) cite Form 4 and 144 filings outside the pleadings, (ii)\n\n ask the Court to accept the truth of assertions therein that sale proceeds were used to\n\n pay taxes, (iii) argue that such use does not support scienter, and (iv) cite a case\n\n (Audible) that does not address \u201ctax\u201d sales but rather sales within a Rule 10b5-1\n\n plan.37 The CAC pleads that Defendants\u2019 stock sales were not within a Rule 10b5-\n\n 1 plan (\u00b6\u00b695(a)-(b)), and Defendants make no contrary proffer. Also, the purported\n\n reasons for Defendants\u2019 sales is a disputed fact unfit for Rule 12(b)(6) resolution.38\n\n\n 36\n Defendants have waived all arguments not presented in their opening brief\n and cannot first make them on reply. In re Fosamax (Alendronate Sodium) Prods.\n Liab. Litig. (No. II), 751 F.3d 150, 157 (3d Cir. 2014) (arguments raised for the first\n time in a reply brief are waived).\n 37\n Rule 10b5-1 plans are used by corporate executives to pre-set the conditions\n and terms of future stock sales. When not created (or adjusted) during a class period,\n such plans may insulate against liability if the stock sales at issue occurred therein.\n 38\n See, e.g., City of Providence v. Aeropostale, Inc., 2013 WL 1197755, at *16\n (S.D.N.Y. Mar. 25, 2013) (defendants election to sell stock to satisfy tax liability\n gave \u201cpersonal motive to keep the stock price inflated\u201d that supported motive\n scienter); Fresno Cnty. Emps.\u2019 Ret. Ass\u2019n v. comScore, Inc., 268 F. Supp. 3d 526,\n 555 (S.D.N.Y. 2017) (rejecting argument that \u201cin-kind\u201d stock sales, e.g. \u201csales to\n cover tax liabilities,\u201d should be discounted in scienter analysis because \u201cmoney is\n fungible\u201d); Roofer\u2019s Pension Fund v. Papa, 2018 WL 3601229, at *17 (D.N.J. July\n 27, 2018) (refusing to resolve dispute about reason for defendants\u2019 sales on motion\n 36\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 45 of 50 PageID:\n 1957\n\n\n\n Motive \u2013 Offerings (Memo at 36-37). Rocket\u2019s corporate offerings were\n\n suspiciously timed, during an extended, undisclosed dosing halt and just before the\n\n nonpublic decision to add the C3 inhibitor, to maximize fraud-inflated proceeds.\n\n \u00b6\u00b696-97; see also Appendix A. These allegations support scienter. See, e.g., In re\n\n Toronto-Dominion Bank Sec. Litig., 2018 WL 6381882, at *19 (D.N.J. Dec. 6, 2018)\n\n (corporate note offerings during fraud support motive scienter); In re NUI Sec. Litig.,\n\n 314 F. Supp. 2d 388, 411-412 (D.N.J. 2004) (motive scienter based on need to\n\n elevate stock price for public offering and to use stock as currency in a merger).39 40\n\n Resignations (Memo at 37-38). The CAC pleads suspiciously-timed, high-\n\n level resignations of Rocket Directors, its CMO, President / COO, and Defendant\n\n Ondrey \u2013 two also pled as corrective disclosures that dropped Rocket\u2019s stock price\n\n\n to dismiss); In re SLM Corp. Sec. Litig., 740 F. Supp. 2d 542, 558 n.6 (S.D.N.Y.\n 2010) (justifications for stock sales, \u201cto pay the exercise price of expiring options\n and associated taxes\u201d are not suitable for motion to dismiss). Moreover, even if\n Defendants had not sold any stock, it would not be definitive. Levon, 797 F. Supp.\n 3d at 427 (lack of class period stock sales \u201cneither bolsters nor defeats scienter\u201d).\n 39\n See also In re Res. Am. Sec. Litig., 2000 WL 1053861, *5-6 (E.D. Pa. July 26,\n 2000) (desire to raise capital via secondary offering supported scienter); In re\n Silvercorp Metals, Inc. Sec. Litig., 26 F. Supp. 3d 266, 275-277 (S.D.N.Y. 2014)\n ($117 million offering evidenced corporate scienter even where all individual\n defendants dismissed); Kendall v. Odonate Therapeutics, Inc., 2021 WL 3406271,\n at *8 (S.D. Cal. Aug. 4, 2021) (corporate offerings netting $222.5 million supported\n scienter even where individual defendants only bought stock); Van Dongen v.\n CNinsure, Inc., 951 F. Supp. 2d 457, 474 (S.D.N.Y. 2013) ($109.6 million secondary\n offering can provide motive for fraud).\n 40\n Defendants\u2019 cases rejecting motive pleadings involved attempts to increase\n performance-based executive compensation (Wilson), earned fees (S. Cherry), or an\n offering not pled as suspiciously-timed with no individual stock sales (MELA).\n 37\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 46 of 50 PageID:\n 1958\n\n\n\n \u2013 support scienter. \u00b6\u00b6109-114; see also Appendix A. In re Hertz Glob. Holdings,\n\n Inc., 905 F.3d 106, 118 (3d Cir. 2018) (executive resignations can support scienter\n\n when combined with allegations of knowing or reckless involvement in fraud).41\n\n Defendants ignore allegations that the CAC\u2019s scienter inference is supported\n\n by the core operations doctrine (\u00b6\u00b6104-106); Shah\u2019s and Ondrey\u2019s signing, being\n\n quoted in, and SOX-certifying Rocket\u2019s allegedly fraudulent SEC filings (\u00b6\u00b6107-\n\n 108); and violations of Rocket\u2019s Corporate Code of Conduct and Insider Trading\n\n Policy (\u00b6\u00b6115-118). They waive challenges at this stage. See n.36, supra.\n\n E. THE CAC ADEQUATELY PLEADS LOSS CAUSATION\n\n \u201cAllegations of loss causation are not subject to the heightened pleading\n\n requirements of Rule 9(b) and the PSLRA: all that is required is that plaintiff provide\n\n \u2018some indication of the loss and the causal connection that the plaintiff has in mind,\u2019\n\n consistent with Rule 8(a).\u201d Dudley v. Haub, 2013 WL 1845519, at *18 (D.N.J. Apr.\n\n 30, 2013) (quoting Dura Pharms., Inc. v. Broudo, 544 U.S. 336, 348 (2005)). \u201cA\n\n plaintiff must show that \u2018the revelation of the alleged misrepresentation or omission\n\n was a substantial factor in causing a decline in the security\u2019s price, thus creating an\n\n\n\n 41\n See also In re Cognizant Tech. Sols. Corp. Sec. Litig., 2020 WL 3026564, at\n *22 (D.N.J. June 5, 2020) (same); Roofer\u2019s, 2018 WL 3601229 at *20 (probative\n value in resignation); In re Par Pharm. Sec. Litig., 2009 WL 3234273, at *10 (D.N.J.\n Sep. 30, 2009) (defendant\u2019s resignation, with other allegations, reinforces scienter);\n In re Valeant Pharms. Int\u2019l, Inc. Sec. Litig., 2017 WL 1658822, at *10 (D.N.J. Apr.\n 28, 2017) (executive and director departures supported scienter).\n 38\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 47 of 50 PageID:\n 1959\n\n\n\n actual economic loss for the plaintiff.\u2019\u201d Levon, 797 F. Supp. 3d at 429 (quoting\n\n McCabe v. Ernst & Young, LLP, 494 F.3d 418, 425-26 (3d Cir. 2007) (emphasis\n\n added)). \u201cCourts in this district have held loss causation is adequately pled when a\n\n company\u2019s stock price declines after media reports and disclosures presented new\n\n information about the alleged fraud to the public.\u201d Id. at 430 (collecting cases). The\n\n pleading burden is not heavy, and \u201c[i]mportantly, \u2018the issue of loss causation is\n\n usually not resolved on a motion to dismiss.\u2019\u201d Id. (collecting cases). \u201cAlthough a\n\n corrective disclosure must be related to the same subject as the misrepresentation,\n\n and not some other adverse facts about the company, there is no requirement that the\n\n disclosure mirror the earlier misrepresentation.\u201d In re Urban Outfitters, Inc. Sec.\n\n Litig., 103 F. Supp. 3d 635, 655 (E.D. Pa. 2015). And, \u201cthe truth can be revealed\n\n through a series of partial corrective disclosures.\u201d Id. (citing In re Merck & Co., Inc.\n\n Sec., Derivative, & ERISA Litig., 2011 WL 3444199, at *31 (D.N.J. Aug. 8, 2011)).\n\n The CAC sufficiently pleads loss causation based on partial corrective\n\n disclosures and correlating stock drops on May 27, August 8, and August 26, 2025.\n\n See \u00a7II, supra; \u00b6\u00b612-13, 82-93. Defendants (Memo at 38-39) misstate the standard\n\n as \u201clearning the falsity of prior material misstatements,\u201d facially counter to their\n\n cited authority (McCabe), and reduce the May 27, 2025 corrective disclosure to only\n\n the patient death revelation. The full corrective disclosure includes a Rocket press\n\n release, 8-K, and webinar and four pre-market-close analyst reports, collectively\n\n 39\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 48 of 50 PageID:\n 1960\n\n\n\n causing a -62.84% stop drop (\u00b6\u00b612, 83-86), as even more analyst reports later\n\n explained (\u00b6\u00b687(a)-(c)). Together, they revealed, inter alia, prior-concealed TMA-\n\n related SAEs, FDA negotiations, resulting trial redesign, the C3 inhibitor\n\n introduction, CLS-related SAEs, a patient death, an ongoing root cause analysis, and\n\n an FDA-imposed clinical hold \u2013 prompting Shah to admit Rocket was \u201cgoing back\n\n to the drawing board.\u201d42 Defendants omitted from their MTD Letter argument as to\n\n the August 8 and 26, 2025 disclosures, thus waiving it. See \u00a7III, supra. If\n\n considered, their claimed need for mirror-image misstatements (Memo at 37 n.5)\n\n fails. Urban Outfitters, 103 F. Supp. 3d at 655-656 (market may learn truth about\n\n misrepresentation from, e.g., analysts, CFO resignation, company announcements).\n\n F. THE CAC\u2019S \u00a720(A) CLAIM SHOULD BE SUSTAINED\n\n Failing to challenge, and thus conceding, Shah and Ondrey controlled Rocket,\n\n Defendants\u2019 only \u00a720(a) claim challenge (Memo at 39-40) is failure to plead a \u00a710(b)\n\n violation. If the \u00a710(b) claim survives, even partly, the \u00a720(a) claim must survive.\n\n V. CONCLUSION\n\n Defendants\u2019 arguments lack merit, and their Motion should be denied in full.\n\n\n\n\n 42\n The CAC\u2019s alleged analyst reports linking the revelations to a higher-than-\n previously-understood A501 risk profile, as part of the corrective disclosure, readily\n distinguishes Defendants\u2019 other cases, where plaintiffs did not clearly explain how\n the corrective disclosure \u201calerted the market\u201d to the stock\u2019s overpricing due to the\n fraud (Intelligroup) or tried to use negative financial results as a proxy for disclosure\n of underlying problems the results did not mention (Nat\u2019l Junior Baseball).\n 40\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 49 of 50 PageID:\n 1961\n\n\n\n Dated: April 1, 2026 Respectfully submitted,\n\n POMERANTZ LLP\n\n /s/ Brian Calandra\n Brian Calandra\n Matthew L. Tuccillo\n Zachary Denver\n 600 Third Avenue, 20th Floor\n New York, New York 10016\n Phone: 212-661-1100\n Facsimile: 917-463-1044\n bcalandra@pomlaw.com\n mltuccillo@pomlaw.com\n zdenver@pomlaw.com\n\n THE ROSEN LAW FIRM, P.A.\n\n Gonen Haklay\n 101 Greenwood Ave., Ste. 520\n Jenkintown, Pennsylvania 19046\n Phone: 215-600-2817\n Facsimile: 212-202-3827\n ghaklay@rosenlegal.com\n\n Laurence A. Rosen\n One Gateway Center, Suite 2600\n Newark, NJ 07102\n Phone: (973) 313-1887\n Facsimile: (973) 833-0399\n lrosen@rosenlegal.com\n\n Co-Lead Counsel for Co-Lead Plaintiff\n Dimitar Yankov, and the Proposed Class\n\n\n\n\n 41\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43 Filed 04/01/26 Page 50 of 50 PageID:\n 1962\n\n\n\n CERTIFICATE OF SERVICE\n\n I, Brian Calandra, hereby certify that I have caused a copy of this Opposition\n\n to Defendants Motion to Dismiss the Consolidated Amended Class Action\n\n Complaint to be served on all counsel by the Court\u2019s CM/ECF System. Notice of\n\n this filing will be sent by e-mail to all parties by operation of the Court\u2019 s electronic\n\n filing system or by mail to anyone unable to accept electronic filing as indicated on\n\n the Notice of Electronic Filing. Parties may access this filing through the Court\u2019s\n\n CM/ECF System.\n\n\n\n /s/ Brian Calandra\n Brian Calandra\n\n\n\n\n 42\n\f","ocr_status":2,"date_upload":"2026-05-15T01:24:22.086693-07:00","document_number":"43","attachment_number":null,"pacer_doc_id":"119023763595","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Response in Opposition to Motion","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479327488/","id":479327488,"tags":[],"absolute_url":"/docket/70517657/43/1/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T01:24:23.259384-07:00","date_modified":"2026-05-18T05:39:35.663175-07:00","sha1":"1aa9c3c7205036c280c3171052d45e452faebbab","page_count":1,"file_size":116568,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.1.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.1.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":" Case 3:25-cv-10049-ZNQ-TJB Document 43-1 Filed 04/01/26 Page 1 of 1 PageID:\n 1963\n\n\n\n In re Rocket Pharmaceuticals, Inc. Sec. Litig., No. 3:25-cv-10049-ZNQ-TJB (D.N.J.)\n Appendix A\n To Lead Plaintiffs' Opposition to Motion to Dismiss The First Amended Complaint (ECF 40)\n Alleged Misstatements, Phase 2 Trial Developments, Corrective Events / Disclosures, Defendant Transactions, Company Offerings, & High-Level Insider Resignations\n\n\n Suspiciously Timed Defendant / Insider Actions\n Alleged Phase 2 Trial Alleged Corrective\n Misstatements Developments Events / Disclosures Defendant Transactions Company Offerings High-Level\n (Number of Shares) (Number of Shares) Insider Resignations\n\n\n2/27/2024 2023 10-K (\u00b662(a)) Shah (\u00b695(a))\n Early 2024: Phase 2 Trial patient #1 sufferred TMA-related SAE (\u00b6\u00b65, 58, 100)\n4/29/2024 2023 Annual Report (\u00b663) 5/14/2024 17,662 RSUs converted to\n [Prompted dosing halt, root cause analysis, FDA negotiations, trial change (\u00b6\u00b65, 58, 102)]\n5/7/2024 Q1 2024 10-Q (\u00b662(a)) shares\n Early/mid 2024: FDA permitted Phase 2 Trial dosing resumption (\u00b6\u00b65, 58)\n5/16/2024 BoA Conference (\u00b664) 5/16/2024 stock sold (9,790 shares)\n\n\n8/6/2024 Q2 2024 10-Q (\u00b662(a)) August 2024: Phase 2 Trial patient #4 sufferred TMA-related SAE (\u00b6\u00b65, 58, 100)\n Shah (\u00b695(a))\n9/5/2024 MS Conference (\u00b665) [Prompted dosing halt until May 2025, FDA negotiations, trial redesign (\u00b65)]\n 8/16/2024 stock sold (9,650 shares)\n9/17/2024 Press Release (\u00b666) 9/17/2024: Phase 2 Trial enrollment announced as complete (\u00b6\u00b646, 48)\n\n11/7/2024 Earnings Release (\u00b667)\n11/7/2024 8-K (\u00b667)\n11/7/2024 Q3 2024 10-Q (\u00b662(b)) 12/12/2024 public offering (\u00b696)\n 12/5/2024 - Rocket General Manager,\n11/12/2024 UBS Conference (\u00b668(a)-(b)) (15.2 million shares)\n Shah (\u00b695(a)) Commercial Affairs / Chief Medical\n11/18/2024 Webinar (\u00b669(a)-(b)) [Dosing remained halted until May 2025 (\u00b6\u00b65, 101)]\n 11/21/2024 stock sold (11,091 shares) Officer Resigned (\u00b6110)\n12/3/2024 Evercore Conference (\u00b670(a)-(b)) 12/12/2024 private placement (\u00b696)\n12/10/2024 Preliminary Prospectus (warrants for 400,000 shares)\nSupplement (\u00b671)\n12/12/2024 Prospectus Supplement (\u00b671)\n\n\n Shah (\u00b695(a))\n1/13/2025 JPM Conference (\u00b672)\n January 2025: Rocket decided to use novel C3 inhibitor, redesign trial (\u00b6\u00b65, 52, 59, 101) 2/21/2025 stock sold (16,303 shares)\n2/27/2025 Earnings Release (\u00b673(a)) 1/27/2025 - Rocket Director Resigned\n [Prompted FDA negotiations, trial redesign, implementation (\u00b65)]\n2/27/2025 8-K (\u00b673(a)) (\u00b6111)\n [Dosing remained halted until May 2025 (\u00b6\u00b65, 101)] Ondrey (\u00b695(b))\n2/27/2025 2024 10-K (\u00b6\u00b662(b), 73(b))\n 4/4/2025 stock sold (7,489 shares)\n\n\n 5/27/2025 Press Release (\u00b683)\n 5/27/2025 8-K (\u00b683)\n 5/27/2025 Webinar (\u00b684(a)-(e))\n Early May 2025: Phase 2 Trial patients #5 + #6 dosed, given C3 inhibitor (\u00b6\u00b65, 53, 84(a), 101) 5/27/2025 Scotiabank Report (\u00b685(a)) Shah (\u00b695(a))\n4/8/2025 Needham Conference (\u00b674)\n May 2025: Phase 2 Trial patients #5 + #6 sufferred CLS-related SAEs (\u00b6\u00b65, 53) 5/27/2025 JPM Report (\u00b685(b)) 5/16/2025 stock sold (3,621 shares)\n4/30/2025 2024 Annual Report (\u00b675)\n [Prompted dosing halt (\u00b679(b))] 5/27/2025 Jefferies Report (\u00b685(c)) 5/20/2025 stock sold (2,253 shares) 4/29/2025 - Rocket Director Resigned\n4/30/2025 Proxy Statement (\u00b676)\n 5/23/2025: FDA imposed clinical hold on Phase 2 Trial (\u00b6\u00b653, 102) 5/27/2025 Needham Report (\u00b685(d)) (\u00b6112)\n5/8/2025 Q1 2025 10-Q (\u00b6\u00b662(b), 77)\n 5/24 to 5/26/2025: Phase 2 Trial patient with CLS-related SAE died (\u00b653) 5/27/2025 stock drop (\u00b686) Ondrey (\u00b695(b))\n5/27/2025 Webinar (\u00b678(a)-(e))\n 5/27/2025: Rocket began root cause analysis into CLS-related SAEs (\u00b678(e)) 7/3/2025 stock sold (1,477 shares)\n 5/27/2025 Cantor Report (\u00b687(a))\n 5/28/2025 JPM Report (\u00b687(b))\n 5/28/2025 Chardan Report (\u00b687(c))\n\n\n 8/7/2025 8-K (\u00b6\u00b688-89)\n8/7/2025 Earnings Release (\u00b679(a)) 8/7/2025 - Rocket President / Head of\n 8/7/2025 Earnings Release (\u00b6\u00b688-89)\n8/7/2025 8-K (\u00b679(a)) 8/20/2025: FDA permitted Phase 2 Trial resumption with a recalibrated dose (\u00b654) Shah (\u00b695(a)) R&D / COO Resigned (\u00b6113)\n 8/7/2025 stock drop (\u00b690)\n8/7/2025 Q2 2025 10-Q (\u00b6\u00b662(b), 79(b)) [No further patients dosed thereafter into 2026 (\u00b6103)] 8/18/2025 stock sold (2,234 shares) 8/20/2025 - Rocket CFO Defendant\n 8/25/2025 8-K (\u00b6\u00b691, 114)\n8/20/2025 Press Release (\u00b680) Ondrey Resigned (\u00b6114)\n 8/25/2025 stock drop (\u00b692)\n\f","ocr_status":2,"date_upload":"2026-05-15T01:24:30.565021-07:00","document_number":"43","attachment_number":1,"pacer_doc_id":"119023763596","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Appendix","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479327489/","id":479327489,"tags":[],"absolute_url":"/docket/70517657/43/2/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T01:24:23.272537-07:00","date_modified":"2026-05-18T05:41:32.528418-07:00","sha1":"1942c83269b61d006a69cee133693b8bf32e3b67","page_count":3,"file_size":138541,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.2.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.2.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 3:25-cv-10049-ZNQ-TJB Document 43-2 Filed 04/01/26 Page 1 of 3 PageID:\n 1964\n\n\n\nBrian Calandra\nPomerantz LLP\n600 Third Avenue, 20th Floor\nNew York, New York 10016\nTelephone: (212) 661-1100\nFacsimile: (917) 463-1044\nbcalandra@pomlaw.com\n\nCo-Lead Counsel for Co-Lead Plaintiff\nDimitar Yankov, and the Proposed\nClass\n\n UNITED STATES DISTRICT COURT\n DISTRICT OF NEW JERSEY\n\n\nIN RE ROCKET Case No. 3:25-cv-10049-ZNQ-TJB\nPHARMACEUTICALS, INC.\nSECURITIES LITIGATION CLASS ACTION\n\n DECLARATION OF MATTHEW L.\n TUCCILLO, ESQ. IN SUPPORT OF\nTHIS DOCUMENT RELATES TO: LEAD PLAINTIFFS\u2019 OPPOSITION\n TO DEFENDANTS\u2019 MOTION TO\nALL ACTIONS DISMISS THE CONSOLIDATED\n AMENDED CLASS ACTION\n COMPLAINT (ECF 40)\n\n\n Pursuant to 28 U.S.C. \u00a71746, I, Matthew L. Tuccillo, Esq., hereby declare as\n\nfollows:\n\n 1. I am over twenty-one years of age and I am fully competent to make\n\nthis Declaration. I have personal knowledge of the facts set forth in this Declaration,\n\nand if called upon, could and would testify completely thereto.\n\n\n\n\n 1\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43-2 Filed 04/01/26 Page 2 of 3 PageID:\n 1965\n\n\n\n 2. I am a Partner of the law firm Pomerantz LLP, Court-appointed Co-\n\nLead Counsel for Lead Plaintiffs Dimitar Yankov and Corey Sipmann. My office is\n\nlocated at 600 Third Avenue, 20th Floor, New York, NY 10016. I make this\n\nDeclaration in support of Lead Plaintiffs\u2019 Opposition to Defendants\u2019 Motion to\n\nDismiss the Consolidated Amended Class Action Complaint (ECF 40).\n\n 3. I am a member of good standing of the Bars of the State of New York,\n\nthe State of Connecticut, and the Commonwealth of Massachusetts. I am also a\n\nmember in good standing of the Bar of the Supreme Court of the United States, the\n\nBars of the U.S. Court of Appeals for the Second, Fifth, and Ninth Circuits, and the\n\nBars of the United States District Courts for the Southern and Eastern Districts of\n\nNew York, the District of Connecticut, the District of Massachusetts, the Northern\n\nDistrict of Illinois, the Eastern District of Wisconsin, and the Southern District of\n\nTexas.\n\n 4. Attached hereto as Exhibit 1 is a true and correct copy of a Form 8-K\n\nfiled by Defendant Rocket Pharmaceuticals, Inc. (\u201cRocket\u201d) with the Securities and\n\nExchange Commission on September 12, 2023 (the \u201c9/12/2023 8-K\u201d).\n\n 5. Attached hereto as Exhibit 2 is a true and correct copy of a slideshow\n\npresentation titled Rocket Pharmaceuticals Danon Disease Program Update and\n\ndated September 11, 2023 (the \u201c9/11/2023 Presentation\u201d), which was filed as Exhibit\n\n99.1 to Rocket\u2019s 9/12/2023 8-K.\n\n\n 2\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43-2 Filed 04/01/26 Page 3 of 3 PageID:\n 1966\n\n\n\n I declare under penalty of perjury under the laws of the United States of\n\nAmerica that the foregoing is true and correct to the best of my knowledge and belief.\n\n Executed in New York, NY on April 1, 2026.\n\n\n\n /s/ Matthew L. Tuccillo\n Matthew L. Tuccillo\n\n\n\n\n 3\n\f","ocr_status":2,"date_upload":"2026-05-15T01:24:33.086209-07:00","document_number":"43","attachment_number":2,"pacer_doc_id":"119023763597","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Declaration of Matthew L. Tuccillo","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479327490/","id":479327490,"tags":[],"absolute_url":"/docket/70517657/43/3/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T01:24:23.285385-07:00","date_modified":"2026-05-18T05:41:38.265617-07:00","sha1":"d611cdabe01aac8447a66040993e304eb1653d46","page_count":6,"file_size":269882,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.3.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.3.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 1 of 6 PageID:\n 1967\n\n\n\n\n EXHIBIT 1\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 2 of 6 PageID:\n 1968\n\n UNITED STATES\n SECURITIES AND EXCHANGE COMMISSION\n Washington, DC 20549\n\n FORM 8-K\n CURRENT REPORT\n Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934\n\n Date of Report (Date of earliest event reported): September 12, 2023\n\n\n\n\n Rocket Pharmaceuticals, Inc.\n (Exact name of registrant as specified in its charter)\n\n\n Delaware 001-36829 XX-XXXXXXX\n(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)\n\n\n 9 Cedarbrook Drive, Cranbury, NJ 08512\n (Address of principal executive offices) (Zip Code)\n\n\n Registrant\u2019s telephone number, including area code: (646) 440-9100\n\n\n Not applicable\n (Former name or former address, if changed since last report)\n\nCheck the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under\nany of the following provisions (see General Instruction A.2):\n\n\u2610 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)\n\n\u2610 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)\n\n\u2610 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))\n\n\u2610 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))\n\nSecurities registered pursuant to Section 12(b) of the Act:\n\n Trading Name of each exchange on which\n Title of each class\n Symbol(s) registered\n Common stock, $0.01 par value RCKT The Nasdaq Global Market\n\nIndicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (\u00a7\n230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (\u00a7 240.12b-2 of this chapter).\n\n Emerging growth company \u2610\n\nIf an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for\ncomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. \u2610\n\fCase 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 3 of 6 PageID:\n 1969\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 4 of 6 PageID:\nItem 7.01 Regulation FD Disclosure. 1970\n\nAttached as Exhibit 99.l to this Current Report on Form 8-K, and incorporated into this Item 7.01 by reference, is an investor\npresentation (the \u201cInvestor Presentation\u201d) prepared by Rocket Pharmaceuticals, Inc. (the \u201cCompany\u201d) providing certain updates on the\nCompany\u2019s Danon Disease Program, including the alignment it recently achieved with the Food and Drug Administration (FDA) on the\ndesign of the Phase 2 pivotal trial of RP-A501 for Danon Disease.\n\nThe information in this Item 7.01, including Exhibit 99.1 is furnished and shall not be deemed \u201cfiled\u201d for purposes of Section 18 of the\nSecurities Exchange Act of 1934, as amended (the \u201cExchange Act\u201d), or otherwise subject to liabilities under that section, and shall not\nbe deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the\nExchange Act, regardless of any general incorporation language in such filings. This Current Report on Form 8-K will not be deemed\nan admission as to the materiality of any information contained in this Item 7.01, including Exhibit 99.1.\n\n\nItem 8.01. Other Events.\n\nOn September 12, 2023, the Company issued a press release announcing that alignment has been reached with the FDA on the design\nof the Phase 2 pivotal trial of RP-A501 for Danon Disease. A copy of the press release is attached hereto as Exhibit 99.2 to this Current\nReport on Form 8-K and is incorporated herein by reference.\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 5 of 6 PageID:\nItem 9.01 Financial Statements and Exhibits. 1971\n\n(d) Exhibits\n\nExhibit No. Description\n99.1 Investor Presentation dated September 11, 2023.\n99.2 Press Release dated September 12, 2023.\nExhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-3 Filed 04/01/26 Page 6 of 6 PageID:\n 1972\n SIGNATURES\n\nPursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed\non its behalf by the undersigned hereunto duly authorized.\n\nDate: September 12, 2023 Rocket Pharmaceuticals, Inc.\n\n By: /s/ Gaurav Shah, MD\n Name: Gaurav Shah, MD\n Title: Chief Executive Officer and Director\n\f","ocr_status":1,"date_upload":"2026-05-15T01:24:44.425017-07:00","document_number":"43","attachment_number":3,"pacer_doc_id":"119023763598","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit 1 - Form 8-K","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479327491/","id":479327491,"tags":[],"absolute_url":"/docket/70517657/43/4/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-05-15T01:24:23.296348-07:00","date_modified":"2026-05-18T05:42:04.860948-07:00","sha1":"08b50d40ee1a7af36f269323ad1204573f764905","page_count":26,"file_size":5544503,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.4.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.43.4.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 1 of 26 PageID:\n 1973\n\n\n\n\n EXHIBIT 2\n EXHIBIT 2\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 2 of 26 PageID:\n 1974\nEX-99.1 2 ny20010507x2_ex99-1.htm EXHIBIT 99.1\n\n Exhibit 99.1\n\n\n\n\nS E E K I N G G E N E T H E R A P Y C U R E S Rocket Pharmaceuticals Danon Disease Program Update September 11, 2023 1 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 3 of 26 PageID:\n 1975\n\n\n\n\n Disclaimer 1 CONFIDENTIAL AND PROPRIETARY Various statements in this presentation concerning Rocket's future expectations, plans and prospects, including without limitation, Rocket\u2019s expectations regarding the safety and effectiveness of product candidates that Rocket is developing to treat Danon Disease (DD), the expected timing and data readouts of Rocket\u2019s ongoing and planned clinical trials, the expected timing and outcome of Rocket\u2019s regulatory interactions and planned submissions, Rocket\u2019s plans for the advancement of its Danon Disease program, including its planned pivotal trial, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as \"believe,\" \"expect,\" \"anticipate,\" \"intend,\" \"plan,\" \"will give,\" \"estimate,\" \"seek,\" \"will,\" \"may,\" \"suggest\" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket\u2019s ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rocket\u2019s ongoing trials, patient enrollment, trial\ntimelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, our ability to submit regulatory filings with he U.S. Food and Drug Administration (FDA) and to obtain and maintain FDA or other regulatory authority approval of our product candidates, Rocket\u2019s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, our competitors\u2019 activities, including decisions as to the timing of competing product launches, pricing and discounting, our integration of an acquired business, which involves a number of risks, including the possibility that the integration process could result in the loss of key employees, the disruption of our ongoing business, or inconsistencies in standards, controls, procedures, or policies, our ability to successfully develop and commercialize any technology that we may in-license or products we may acquire and any unexpected expenditures, as well as those risks more fully discussed in the section entitled \"Risk Factors\" in Rocket\u2019s Annual Report on Form 10-K for the year ended December 31, 2022, filed February 28, 2023 with he SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 4 of 26 PageID:\n 1976\n\n\n\n\nDanon Disease Aggressive genetic hypertrophic cardiomyopathy with very high early mortality Danon Disease is the most aggressive and lethal hypertrophic cardiomyopathy Monogenic, X-linked disease progresses to severe cardiomyopathy at early ages; characterized by massive LV hypertrophy and end-stage heart failure Uniformly fatal with early mortality (males ~19 yrs.; females ~37 yrs.) Only definitive treatment is cardiac transplantation, availability is limited, and associated with extensive short- and long-term morbidity and mortality (<50% 10-yr survival post HTx) Estimated prevalence of 15,000 to 30,000 individuals and annual incidence of 800 to 1,200 individuals in US & EU In July 2023, US Dept. Health and Human Services approved IDC 10 Code for DD (E74.05) Gene mutation leads to decreased LAMP2B protein and impaired autophagy Cenacchi G et al. Neuropathol. Appl. Neurobiol. 2020; Rowland T et al. J Cell Sci. 2016; Boucek D, Jirikowic J, Taylor M. Genet Med 2011; Thrush P et al. J Thorac Dis. 2014; Dipchand A et al. J Heart Lung Transplant. 2014 Impaired autophagy leads to \u2191 vacuoles, myocyte hypertrophy, necrosis, & fibrosis 1 2 3 Pathologic processes lead to phenotype of extreme LV hypertrophy and cardiomyopathy 4 Natural History: High rates of death at early ages Females Males 3 3 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 5 of 26 PageID:\n 1977\n\n\n\n\nNatural History: Progression of Danon Disease in Male Patients Birth to 7 yrs NYHA Class I Muscle pain, lack of energy Learning difficulties HF symptoms (rare) Identification by incidental genetic testing or family history Death avg age: 19 years 8-14 yrs NYHA Class I-II HCM & genetic diagnosis Worsening fatigue, Shortness of breath on mild exercise Palpitations, syncope, chest tightness Thickening heart, increasing NPs, troponins 15-19 yrs NYHA Class II-III Life-threatening ventricular arrhythmias ICD/pacemaker placement Progression to end-stage cardiomyopathy Listing for heart transplant Significant increase in caregiver burden Thickening heart, increasing NPs, troponins, fibrosis; decline in LVEF Late Teens / Early Twenties Significant cardiac dysfunction Heart failure Heart transplant / VAD (~20% of patients), comes with significant short- and long- term complications Anxiety, depression Unemployment Figure created based on data from Brambatti M et al. Int J Cardiol. 2019;286:92-98; Boucek D, Jirikowic J, Taylor M. Genet Med 2011; 13(6):563-68 CONFIDENTIAL AND PROPRIETARY 4 Critical interval in childhood / early adolescence precedes rapid decline, providing optimal window of opportunity for GTx Patients typically on maximal medical management (e.g. beta blockers, ICD) - none alter disease progression Note: Danon disease is a life-threatening and seriously debilitating condition. Above are not meant to be a strict categorization of symptoms/outcomes by age. Heart failure and death from Danon disease can occur well before the patient reaches his twenties. Of note, the four adult patients in the Phase 1 study with 2.5-3.5 yr follow-up post gene therapy are currently alive, clinically stable, and free from Danon disease\nprogression at ages 21-24 years old \u2013 in contrast to the trend in the natural history of this disease. NYHA = New York Heart Association Class; ICD: implantable cardioverter-defibrillator; HTx = Heart Transplantation; VAD: Ventricular Assist Device\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 6 of 26 PageID:\n 1978\n\n\n\n\nPhase 1 Data: Benefit Observed Across All Key Clinical Parameters Early LAMP2, BNP, TnI changes associated with sustained clinical improvement and guided Phase 2 endpoint selection Does not include pt 1007 in Ph1 trial who had advanced HF with EF<40% at enrollment and received HTx 5M following tx due to pre-existing advanced HF. Patient is currently stable. BNP, brain natriuretic peptide; hsTnI, high- sensitivity troponin I; KCCQ, Kansas City Cardiomyopathy Questionnaire; LAMP2, lysosome-associated membrane protein 2; LV, left ventricle; NYHA, New York Heart Association. Data cut-off Oct 6, 2022; Grade 0=negative All specified parameters either improved or stabilized (none deteriorated) Improved Stabilized Worsened 5 CONFIDENTIAL AND PROPRIETARY staining; Grade 1 \u226425%; Grade 2 =26%-50%; Grade 3 =51%-75%; Grade 4 >75%. Low dose = 6.7x1013 GC/kg, high dose = 1.1x1014 GC/kg CONFIDENTIAL AND PROPRIETARY 5 Cohort Patient ID Follow-up (months) Myocardial LAMP2 Grade (\u2264M12) TnI \u0394 (\u2264M12) BNP \u0394 (\u2264M12) LV mass \u0394 (g) LV Mass Index \u0394 (g/m^2.7) Max LV Wall Thickness \u0394 (mm) NYHA class \u0394 KCCQ score \u0394 Low dose adult/ adolescent 1001 36 1 -75% (M18) -36% 311 \u21e2 212 85 \u21e2 57 25 \u21e2 23 II \u21e2 II 44 \u21e2 49 1002 36 3 -79% -76% 989 \u21e2 511 260 \u21e2 129 64 \u21e2 38 II \u21e2 II 64 \u21e2 81 1005 30 2 (M9) -57% (M9) -64% (M9) 438 \u21e2 375 98 \u21e2 76 33 \u21e2 24 II \u21e2 I 77 \u21e2 85 (M24) High dose adult/ adolescent 1006 24 1 -47% -70% 410 \u21e2 300 90 \u21e2 63 22 \u21e2 18 II \u21e2 I 79 \u21e2 82 Low dose pediatric 1008 12 1 -86% -83% 605 \u21e2 447 140 \u21e2 96 42 \u21e2 39 II \u21e2 I 50 \u21e2 82 1009 6 1 -90% -62% 234 \u21e2 185 83 \u21e2 63 20 \u21e2 20 II \u21e2 I 52 \u21e2 78\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 7 of 26 PageID:\n 1979\n\n\n\n\nLatest Pediatric Data Shows Sustained Improvements in Biomarkers, Symptoms, and Function (Updated Data) Variable Baseline2 Most Recent Follow-up LAMP2 protein3 0 1 (M6) Troponin-I (ng/mL) 0.67 0.08 (-88%) BNP (pg/mL) 297 163 (-45%) NYHA Class II I LV Mass Index 83 60 (-28%)4 12 months AGE AT INFUSION 11.7 years ICD no WPW no Subject ID: A501-008-1008 Baseline Characteristics AGE AT INFUSION 12.3 years ICD yes1 WPW yes Variable Baseline2 Most Recent Follow-up LAMP2 protein3 0 1 (M12) Troponin-I (ng/mL) 1.89 0.30 (-84%) BNP (pg/mL) 1837 328 (-82%) NYHA Class II I LV Mass Index 140 96 (-31%)4 18 months MAX LV WALL THICKNESS 41.9 mm, z-score +32 6MWT 438 meters MAX LV WALL THICKNESS 19.8 mm, z-score +12 6MWT 553 meters Subject ID: A501-008-1009 Baseline Characteristics 1 Recommended prior to enrollment; ICD implanted 3 months after RP-A501 infusion. 2 Baseline values for troponin-I and BNP are the mean values from all pre-dose visits. 3 Extent of LAMP2 expression grading: Grade 0 = negative staining, Grade 1 < 25%, Grade 2 = 26-50%, Grade 3 = 51-75%, Grade 4 > 75%. 4M12 Note: All data preliminary, not yet validated. 6MWT, 6-minute walk test; BNP, brain natriuretic peptide; ICD, implantable cardioverter defibrillator; KCCQ, Kansas City cardiomyopathy questionnaire; LAMP2, lysosome-associated membrane protein 2; LV, left ventricle; NYHA, New York Heart Association; WPW, Wolff-Parkinson-White syndrome. 6 6 CONFIDENTIAL AND PROPRIETARY `\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 8 of 26 PageID:\n 1980\n\n\n\n\n\u200bPivotal, single-arm study \u200bPeds safety run-in \u200bDosage (6.7x1013 GC/kg) \u200bSafety protocol & management plan \u200bCMC (product comparability and potency assay) \u200bNHS to serve as external comparator \u200bRMAT designation granted F2F meeting with review team and senior FDA leadership Co-primary endpoint to support accelerated approval consisting of LAMP2 expression & LV Mass reduction of \u2265 10% N=12 patients for pivotal study with potential for primary endpoint readout at 12 months Study to support AA with a path towards conversion to full approval (with longer follow-up) FDA Engagement and Alignment on Danon Program Since the EOP1 Meeting in November 2022, Rocket has had collaborative formal and informal discussions with FDA to align on the optimal pivotal Phase 2 study design Previously Disclosed Trial Elements Recent Engagement and Alignment 8 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 9 of 26 PageID:\n 1981\n\n\n\n\nPhase 2 Trial Design \u2013 12 Patients with 12-month Primary Endpoint Duration Dose: 6.7 x 1013 GC/kg of commercially representative RP-A501 material Initial n=2 peds followed for 90 days for key AAV-associated toxicities prior to subsequent ped pt enrollment Key eligibility criteria: male age \u22658y, LAMP2 mutation, NYHA II-III, evidence of LV hypertrophy, elevated hsTnI CO-PRIMARY ENDPOINT (AA) LAMP2 protein \u2265 Grade 1 (IHC) AND Left Ventricular Mass (LV Mass): \u226510% \u2193 SECONDARY & EXPLORATORY ENDPOINTS hs-troponin I (key secondary) Natriuretic peptides QoL instruments (KCCQ, PedsQL, PGI-C, PGI-S) NYHA Class 6MWT Event free survival Treatment emergent safety events Actigraphy Tx, treatment; LV, left ventricular; NYHA; IDSMC, Independent Data Safety and Monitoring Committee; hs-troponin I; KCCQ; HF; m, month; y, year; pts, patients Adolescent/Adult Cohort \u226515y End of Study 60m Primary Endpoint Assessment ~12m RISK MANAGEMENT PLAN, TRIAL OVERSIGHT Immunomodulatory regimen of Rituximab, Sirolimus, corticosteroids. Clinical monitoring team to closely monitor labs, clinical sequelae for AAV-associated toxicities. IDSMC: expertise in adult and pediatric cardiomyopathy, immunology, and biostatistics RP-A501 Tx CONCURRENT NATURAL HISTORY STUDY 90d (Additional pediatric dosing following Safety Run-in) Pediatric (8-14y) Safety Run-in (n=2) RP-A501 Tx Peds pt #1 Peds pt #2 1m Safety observation Pivotal, global, single-arm, open label study with external comparator PIVOTAL PHASE 2 STUDY DESIGN 8 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 10 of 26 PageID:\n 1982\n\n\n\n\n9 HTx, heart transplant; LVEF, LVEF, left ventricle ejection fraction. US Retrospective Natural History 9 Males 1 Female 51 Males 21 Males 38 Females Initiated in 2019, study complete Initiated in 2006 Enrollment complete; analysis in Q4 2023 67 Females Prospective Natural History Study EU Retrospective Natural History Study To be expanded through an additional prospective Rocket-initiated natural history study Key Elements of Study Design: Entry criteria and endpoints similar to Phase 2 trial Appropriate matching to ensure robust comparisons Retrospective data collection to supplement prospective evaluation to ensure sufficient comparative data Prospective, Retrospective Natural History Study as External Comparator Allows for robust comparisons and aligned with FDA guidance 9 CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 11 of 26 PageID:\n 1983\n\n\n\n\n10 Transplant-free survival Totality of Evidence to Demonstrate Treatment Effect Baseline 12 Months 18 Months 24 Months Beyond 24-36 Months HF Hospitalizations Heart Transplant Death Phase 2 RP-A501 Treated Patients External Comparator Natural History (Untreated Patients) Each patient\u2019s baseline AND matched external comparator arm together provide robust control data to assess treatment effect Improvement or stabilization of parameter Worsening of parameter Clinical Assessments Outcomes (Late \u0394) Imaging & Biomarkers (Early \u0394) (Intermediate \u0394) External comparator arm serves as control at each timepoint CONFIDENTIAL AND PROPRIETARY Note: Illustrative representation of potential treatment effects versus natural history\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 12 of 26 PageID:\n 1984\n\n\n\n\n Co-Primary Endpoints for Accelerated Approval\n\n\n\n\n rocket\n pharma\n\n\n\nCo-Primary Endpoints for Accelerated Approval 11 CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY\n CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 13 of 26 PageID:\n 1985\n\n\n\n\n12 Primary Endpoint Is Reasonably Likely to Predict Clinical Benefit Justification for use of LAMP2 protein expression and LV Mass Mutation of LAMP2 is root cause of Danon disease Epidemiologic support: even modest levels of LAMP2 confer a 2-decade survival advantage in female patients RP-A501 delivers full coding sequence of WT LAMP2 gene Pre-clinical LAMP2 restoration conferred histologic, functional and survival benefits in LAMP2 knock-out model1 Phase 1: LAMP2 expression associated with decreased vacuolar area, improved myofibrillar disarray, clinical improvement WT Full Length LAMP2 Protein Expression Left Ventricular Mass Largest known hearts are Danon disease hearts Severity of the cardiomyopathy in Danon disease is the major prognostic factor2 Retrospective natural history shows year-over-year increases in LV mass in Danon disease patients Phase 1: Consistent and significant reductions in LV mass as early as 6 months by echocardiography and cardiac MRI Primary Endpoint Will Be Interpreted in a Clinical Context: All components are measurable and unlikely to improve in the absence of a true treatment effect Primary endpoint will be assessed in the context of biomarkers, symptoms, QOL, clinical events derived from secondary endpoints and concurrent natural history study Phase 1 trial: LAMP2 expression and LV Mass improvements seen as early as 6 months in pediatric subjects with updated immunomodulation regimen 1 Manso 2020. Sci Transl Med.; 2D\u2019souza 2017. J Community Hosp Intern Med Perspect. CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 14 of 26 PageID:\n 1986\n\n\n\n\nMechanistic Pathway: Protein Expression to Cardiac Structure to Clinical Outcomes Improvements Across Cellular, Cardiac Imaging and Functional Measures in Phase 1 Study Molecular Expression Cellular Structure Cardiac Structure and Function Clinical Status Endomyocardial Bx: LAMP2 protein expression Endomyocardial Bx: Vacuolar area Imaging & Biomarkers: LV Mass, Wall thickness, LVEF Troponin-I, BNP Functional parameters: NYHA Class KCCQ Overall Score Patient Screening Month 3 Month 6 Month 24 Month 36 Predose (Baseline) RP-A501 Note: BNP, brain natriuretic peptide; Bx, biopsy; KCCQ, Kansas City cardiomyopathy questionnaire; LAMP2, lysosome-associated membrane protein 2; LV, left ventricle; LVEF, LV ejection fraction; LVPWd, LV posterior wall end diastole; MLVWT, maximal LV wall thickness; NYHA, New York Heart Association LAMP2 expression and LV Mass are mechanistically linked to functional measures and clinical outcomes; reasonably likely to predict clinical benefit Month 9 Month 12 Month 18 Post Gene Therapy 1 2 3 4 13 13 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 15 of 26 PageID:\n 1987\n\n\n\n\nLAMP2 mutation and associated protein deficit is the root cause of Danon disease pathology Grade \u22651 LAMP2 correlates with evidence of efficacy in Ph1 Absent expression at baseline (Grade 0) in all male patients Improved cardiac biomarkers & hypertrophy, PRO/QOL and NYHA Class \u2013 sustained to 3+ years in adult patients, and 12+ months in pediatric patients Efficacy consistent in patients with Grade 1 vs. Grade >1 LAMP2 expression Ph1 expression correlates with \u2193 autophagic vacuoles and improved myofibrillar disarray, cardiac biomarkers and hypertrophy In Danon females, partial LAMP2 expression associated with ~2 decade longer survival than males LAMP2 Protein Expression as Co-Primary Endpoint RP-A501 encodes full-length, wild-type LAMP2B; cardiomyocytes are non-dividing cells 14 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 16 of 26 PageID:\n 1988\n\n\n\n\nRocket AHA 2022 Poster Presentation reflects September 27, 2022 data cutoff. LAMP2, lysosome associated membrane protein 2; M, month. IHC = immunohistochemistry RP-A501 Increases LAMP2 Protein and Decreases Vacuolization Enhanced autophagy leads to improved myocardial ultrastructure and clinical phenotype Myocardial LAMP2 Protein Expression Endomyocardial Biopsy Images (Subject 1008, RP-A501 Phase 1 Study) Vacuolar Area of Endomyocardial Tissue 15 CONFIDENTIAL AND PROPRIETARY 15 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 17 of 26 PageID:\n 1989\n\n\n\n\nLeft Ventricle Mass as Co-Primary Endpoint Danon Disease is fundamentally a disease of enlarged hearts; the largest known hearts have been from Danon patients Left ventricular hypertrophy is the most consistent phenotypic feature of disease progression Left ventricular wall thickness has been shown to be a significant predictor of CV events in cardiomyopathy Meaningful LV Mass decreases seen as early as 6-9M in Phase 1 pediatric cohort, and LV Mass Index decreases sustained to up to 36M in adult patients; stark contrast to natural history In Phase 1 study, LV Mass significantly correlated with improvements / stabilization in all parameters including biomarkers (hsTnI, BNP), quality of life (KCCQ), and symptoms (NYHA) 17 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 18 of 26 PageID:\n 1990\n\n\n\n\nLVH Predicts Clinical Outcomes in HF and Cardiomyopathies 17 CONFIDENTIAL AND PROPRIETARY Shah A, JACC 2019; de Simone G. Eur Heart J. 2008; Liu, Q, Scientific Reports, 2016; Orsborne C, JACC, 2022; Hanneman K. Radiology. 2020 Cardiomyopathy or CVD Measure of LVH Event HR; CI; p value HFpEF (Shah 2019) LV Mass index CVD or HFH HR 1.05 per 10 g/m(2); CI 1.00 to 1.10; p = 0.03 HFpEF (de Simone 2008) LV Mass index HF HR 1.03; CI 1.02-1.04; p<0.00001 HCM (Liu 2016) LV wall thickness All Cause Death HR 1.48; CI 1.01 to 2.17; p<0.05 HCM (Liu 2016) LV wall thickness CV Death HR 2.17; CI 1.06 to 1.89; p<0.05 HCM (Liu 2016) LV wall thickness Sudden Cardiac Death HR 3.17; CI 1.64 to 6.13; p<0.05 Fabry Disease (Orsborne 2022) LV Mass index Composite of CV events (HFH, MI, procedures, arrhythmias) HR 1.008; CI 1.003-1.014; p=0.005 Fabry Disease (Hanneman 2020) LV Mass index Composite of CV events (HF, ventricular arrhythmia, cardiac death) HR 1.1 per 5 g/m2; CI 1.04-1.2; p<0.001\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 19 of 26 PageID:\n 1991\n\n\n\n\nLV Mass Index in RP-A501 Phase 1 Study RP-A501 Phase 1 Low-Dose Cohort: LV Mass Index % Change from Baseline1 Baseline 6M 9M 12M 18M 24M 30M -55% -50% -45% -40% -35% -30% -25% -20% -15% -10% -5% 0% 36M 1002 1005 1008 1009 1 Does not include patient 1001 (unmonitored immunomodulation). 212M visit data missing for 1002 and 1005 due to pandemic-related travel issues. CONFIDENTIAL AND PROPRIETARY 18 RP-A501 Phase 1 Study: LV Mass Index % CFB at ~12M (9M or 18M where 12M not available)2 18M 9M 12M 12M -15% -14% -32% -27% 1002 1005 1008 1009 >20% LVMI decrease observed as early as 6M in pediatric cohort, sustained to 12M timepoint Adult patients with appropriate immunomodulation show >10% LVMI decrease around 12M2 with further decreases out to 30-36M of 22% to 51%\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 20 of 26 PageID:\n 1992\n\n\n\n\nFabry Disease (Agalsidase alfa) LV Mass @6M 8.8% -4.1% Clinical Correlation: Improvements in LVM out to 36M correlated with HF symptoms (NYHA, CCS); drug approved in EU Amyloid Cardiomyopathy (Patirisan) LV Mass @18M <1% -5.6% Clinical Correlation: Drug approved based on improved CV outcomes @30M Significant improvements in 6MWD & NT-proBNP HCM (Mavacamten) LVMI @7M -1.7% -17% Clinical Correlation: \u2191 exercise tolerance at 30 weeks NYHA Class \u2193 by 1 in 76% treated patients at 120wks Danon Disease1 (RP-A501 Low-dose cohort) 8% LVMI LVMI @9-18M3 @30-36M4 Est. LVM Increase per NxHx2 -22% -36% Clinical Correlation: NYHA Class improvement, KCCQ \u2191, improvement or stabilization in hsTnI and natriuretic peptides all to most recent timepoint (12-36M) LV Mass / LV Mass Index (LVMI) Improves in DD with RP-A501 LV hypertrophy decreases greater than/comparable to other approved therapies Placebo / Untreated Estimate from retrospective NxHx Data Treated 1 RP-A501 Phase 1 low-dose cohort data; averages do not include 1001 (unmonitored immunomodulation) and 1006, 1007 (high dose patients). 2 Reflects estimated LV Mass increase over 12-18M for DD patients based on retrospective natural history data-set (shown on slide 20). 3 Reflects average of 1002 18M, 1005 9M, 1008 12M, 1009 12M. 4 Reflects average of 1005 30M, 1002 36M Hughes 2008. Heart; Solomon 2019. Circulation; Saberi 2021. Circulation 19 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 21 of 26 PageID:\n 1993\n\n\n\n\nLV Mass in RP-A501 Low-Dose Cohort Versus Recently Approved CV Therapies -30% -20% -10% 0% 10% Baseline \u226418M DD RP-A501 Tx1 (9-18M); -22% DD RP-A501 Tx1 (30-36M); -36% 30-36M Fabry \u2013 Agalsidase Alfa Untreated (6M); +9% DD UnTx @12M (Estimated based on Retro NxHx2); +8% Amyloidosis \u2013 Tafamidis Treated (9M); -3.6% HCM - Mavacamten Untreated (7M); -1.7% Amyloidosis \u2013 Patisiran Untreated (18M); +1% Amyloidosis \u2013 Tafamidis Untreated (9M); +8.1% Fabry \u2013 Agalsidase Alfa Treated (6M); -4% Amyloidosis \u2013 Patisiran Treated (18M); -5.6% HCM - Mavacamten Treated (7M); -17% Data from Phase 1 study shows RP-A501 is potentially transformative for cardiac structure improvements and remodeling On par with recently approved therapies in other CV indications (across different disease etiologies and drug MOA's) Hughes 2008. Heart; Rettl 2022. EHJ CV Imaging; Solomon 2019. Circulation; Saberi 2021. Circulation CONFIDENTIAL AND PROPRIETARY 20 LV Mass / LVMI Change from Baseline in Treated vs Untreated Patients: RP-A501 Low-Dose Cohort1 and Recently Approved CV Therapies -40% 1 Averages do not include patient 1001 (unmonitored immunomodulation) and 1006, 1007 (high-dose cohort patients). 2 Reflects estimated LV Mass increase over 12-18M for DD patients based on retrospective natural history data-set (shown on slide 20).\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 22 of 26 PageID:\n 1994\n\n\n\n\n* Unpublished data from International Danon Disease Registry 21 Cardiac Imaging Captures the Progression of Danon Disease Significant Increases in LV Mass and LV Wall Thickness Correlate with Age Trends in LV Mass LV Mass increased by 39.86 \u00b1 4.01 g per year Left ventricular mass [g] r2= 0.846 Age (years) Age (years) Interventricular Septum (IVSd) [mm] Age [years] Trends in Septal Wall Thickness Septal wall increased by 0.96 \u00b1 0.10 mm/year 21 CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY Data from the Natural History Studies demonstrated increases in key echo parameters in DD that are known to predict disease progression in other types of cardiomyopathy n=33 n=22\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 23 of 26 PageID:\n 1995\n\n\n\n\nNote: Upper limit of normal 0.04 ng/mL, BL = baseline 22 Significant and Sustained Reduction in Troponin (Key Secondary Endpoint) Observed Across Patients in Phase 1 Study Phase 1 Trial: RP-A501 Treatment Conferred Improvement in Troponin-I Levels (ng/mL) 2.00 1.80 1.60 1.40 1.20 1.00 0.80 0.60 0.40 0.20 0.00 BL M12 M18 M24 M30 M36 1001 1002 1005 1006 1008 Normal Range 22 CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 24 of 26 PageID:\n 1996\n\n\n\n\n Current Status and Next Steps\n\n\n\n\n rocket\n pharma\n\n\n\nCurrent Status and Next Steps 22 CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY\n CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 25 of 26 PageID:\n 1997\n\n\n\n\nOngoing Danon Global Phase 2 Study Activities RMAT, Fast Track, Orphan Drug Designations IRB approval at UCSD, CHOP; sites activated Multiple GMP lots manufactured in-house; sufficient drug product produced for full pivotal trial Global natural history study underway FDA alignment on design Initiated pediatric safety run-in United States Europe (UK + EU) Key regulatory designations obtained: PRIME Designation Orphan Drug Designation Advanced Therapy Medicinal Product Scientific Advice Meeting held with EMA On track for CTA/IMPD filing Multiple EU clinical site startup activities underway Successful QP audit of Rocket manufacturing facility; drug product cleared for EU use Global Phase 2 Study (N=12) 24 CONFIDENTIAL AND PROPRIETARY 25 CONFIDENTIAL AND PROPRIETARY\n\f Case 3:25-cv-10049-ZNQ-TJB Document 43-4 Filed 04/01/26 Page 26 of 26 PageID:\n 1998\n\n\n\n\nRocket Pipeline: 6 Disclosed Programs Across Two Platforms with Compelling Clinical and/or Pre-clinical Proof of Concept On-target MOA; clear endpoints Sizeable market to maximize patient impact First-, best- and/or only-in- class Criteria used to 6+ programs with 2 programs fast approaching commercialization select programs Wave 2 programs DISCOVERY PRECLINICAL PHASE 1 PHASE 2 (Pivotal) Submission and Approval DESIGNATIONS AAV RP-A501 Danon Disease LV RP-L102 Fanconi Anemia LV RP-L201 Leukocyte Adhesion Deficiency-I LV RP-L301 Pyruvate Kinase Deficiency Multiple Undisclosed Candidates AAV BAG3-DCM THERAPEUTIC AREA AAV RP-A601 PKP2-ACM CARDIOVASCULAR HEMATOLOGY RMAT, ATMP, Fast Track, Rare Pediatric, Orphan Drug (US/EU), PRIME RMAT, ATMP, Fast Track, Rare Pediatric, Orphan Drug (US/EU), PRIME RMAT, Fast Track, Orphan Drug (US/EU), PRIME RMAT, Fast Track, Orphan Drug (US), Rare Pediatric Designation, PRIME Fast Track, Orphan Drug (US) 24 CONFIDENTIAL AND PROPRIETARY 25 CONFIDENTIAL AND PROPRIETARY AAV, adeno-associated virus; ATMP, advanced therapy medicinal product; BLA, Biologics License Application; LV, lentiviral vector; MAA, Marketing Authorisation Application; MOA, mechanism of action; PRIME, PRIority MEdicines; RMAT, regenerative medicine advanced therapy. PKP2: plakophilin 2; ACM: Arrhythmogenic Cardiomyopathy; BAG3: BLC2-associated athanogene 3 DCM: Dilated Cardiomyopathy\n\f","ocr_status":1,"date_upload":"2026-05-15T01:24:51.818852-07:00","document_number":"43","attachment_number":4,"pacer_doc_id":"119023763599","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit 2 - 9/11/2023 Presentation","acms_document_guid":""}],"date_created":"2026-04-01T20:37:16.454280-07:00","date_modified":"2026-05-29T03:19:40.339625-07:00","date_filed":"2026-04-01","time_filed":"23:23:15","entry_number":43,"recap_sequence_number":"2026-04-01.001","pacer_sequence_number":176,"description":"RESPONSE in Opposition filed by Corey Sipmann, DIMITAR YANKOV re 40 MOTION to Dismiss (Attachments: # 1 Appendix, # 2 Declaration of Matthew L. Tuccillo, # 3 Exhibit 1 - Form 8-K, # 4 Exhibit 2 - 9/11/2023 Presentation)(CALANDRA, BRIAN) (Entered: 04/01/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/458523289/","id":458523289,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/473529006/","id":473529006,"tags":[],"absolute_url":"/docket/70517657/42/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-03-25T13:03:55.668092-07:00","date_modified":"2026-05-29T03:19:40.307016-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"42","attachment_number":null,"pacer_doc_id":"119023731575","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Order on Motion for Miscellaneous Relief","acms_document_guid":""}],"date_created":"2026-03-25T13:03:55.629272-07:00","date_modified":"2026-05-29T03:19:40.283747-07:00","date_filed":"2026-03-25","time_filed":"15:51:51","entry_number":42,"recap_sequence_number":"2026-03-25.001","pacer_sequence_number":172,"description":"ORDER granting 41 Motion for Withdrawal of Appearance by Loly G. Tor Only. Signed by Magistrate Judge Tonianne J. Bongiovanni on 3/25/2026. (ld) (Entered: 03/25/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/458121062/","id":458121062,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/473116849/","id":473116849,"tags":[],"absolute_url":"/docket/70517657/41/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-03-22T13:40:05.112336-07:00","date_modified":"2026-05-29T03:19:40.254162-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"41","attachment_number":null,"pacer_doc_id":"119023716011","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Notice (Other)","acms_document_guid":""}],"date_created":"2026-03-22T13:40:05.076693-07:00","date_modified":"2026-05-29T03:19:40.232991-07:00","date_filed":"2026-03-22","time_filed":"16:23:17","entry_number":41,"recap_sequence_number":"2026-03-22.001","pacer_sequence_number":170,"description":"NOTICE by AARON ONDREY, ROCKET PHARMACEUTICALS, INC., GAURAV SHAH of Withdrawal of Appearance by Loly G. Tor Only (TOR, LOLY). (Entered: 03/22/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/452361996/","id":452361996,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/467228390/","id":467228390,"tags":[],"absolute_url":"","date_created":"2026-02-02T08:04:19.913919-08:00","date_modified":"2026-02-02T08:04:19.919365-08:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"","attachment_number":null,"pacer_doc_id":"","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Set/Reset Motion and R&R Deadlines/Hearings","acms_document_guid":""}],"date_created":"2026-02-02T08:04:19.902074-08:00","date_modified":"2026-02-02T08:04:19.902086-08:00","date_filed":"2026-02-02","time_filed":"10:36:43","entry_number":null,"recap_sequence_number":"2026-02-02.001","pacer_sequence_number":null,"description":"","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/452234477/","id":452234477,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/467096508/","id":467096508,"tags":[],"absolute_url":"/docket/70517657/40/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-01-30T14:38:35.476494-08:00","date_modified":"2026-05-29T03:19:40.152198-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"40","attachment_number":null,"pacer_doc_id":"119023533435","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Dismiss","acms_document_guid":""}],"date_created":"2026-01-30T14:38:35.408527-08:00","date_modified":"2026-05-29T03:19:40.127350-07:00","date_filed":"2026-01-30","time_filed":"17:17:53","entry_number":40,"recap_sequence_number":"2026-01-30.001","pacer_sequence_number":164,"description":"MOTION to Dismiss by AARON ONDREY, ROCKET PHARMACEUTICALS, INC., GAURAV SHAH. Responses due by 4/1/2026. (Attachments: # 1 Brief, # 2 Declaration of Loly G. Tor, # 3 Exhibit A, # 4 Exhibit B, # 5 Exhibit C, # 6 Exhibit D, # 7 Exhibit E, # 8 Exhibit F, # 9 Exhibit G, # 10 Exhibit H, # 11 Exhibit I, # 12 Exhibit J, # 13 Exhibit K, # 14 Exhibit L, # 15 Exhibit M, # 16 Exhibit N, # 17 Exhibit O, # 18 Exhibit P, # 19 Exhibit Q, # 20 Exhibit R, # 21 Exhibit S, # 22 Exhibit T, # 23 Exhibit U, # 24 Exhibit V, # 25 Exhibit W, # 26 Exhibit X, # 27 Exhibit Y, # 28 Exhibit Z, # 29 Exhibit AA, # 30 Exhibit BB, # 31 Exhibit CC, # 32 Exhibit DD, # 33 Exhibit EE, # 34 Text of Proposed Order)(TOR, LOLY) (Entered: 01/30/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/449236938/","id":449236938,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/464025235/","id":464025235,"tags":[],"absolute_url":"/docket/70517657/37/ho-v-rocket-pharmaceuticals-inc/","date_created":"2026-01-05T10:22:39.813400-08:00","date_modified":"2026-05-29T03:19:39.978662-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"37","attachment_number":null,"pacer_doc_id":"","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"","acms_document_guid":""}],"date_created":"2026-01-05T10:22:39.782888-08:00","date_modified":"2026-05-29T03:19:39.949627-07:00","date_filed":"2025-12-17","time_filed":null,"entry_number":37,"recap_sequence_number":"2025-12-17.001","pacer_sequence_number":null,"description":"TEXT ORDER that the Court has reviewed the parties' pre-motion letters 35, 36 and hereby WAIVES the pre-motion conference. Defendants shall file their Motion, limited to the arguments set forth in their pre-motion letter, by no later than 01/09/2026, to be made returnable 02/02/2026. So Ordered by Judge Zahid N. Quraishi on 12/17/2025. (Gonzalez, P) (Entered: 12/17/2025)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/447777324/","id":447777324,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/70517657/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/462537766/","id":462537766,"tags":[],"absolute_url":"/docket/70517657/39/ho-v-rocket-pharmaceuticals-inc/","date_created":"2025-12-19T08:40:24.083085-08:00","date_modified":"2026-05-29T03:19:40.081506-07:00","sha1":"ffdf607f278b6bfa7d117d19a41571df73833be1","page_count":2,"file_size":211253,"filepath_local":"recap/gov.uscourts.njd.575164/gov.uscourts.njd.575164.39.0_2.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.njd.575164/gov.uscourts.njd.575164.39.0.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":" Case 3:25-cv-10049-ZNQ-TJB Document 39 Filed 12/19/25 Page 1 of 2 PageID: 631\n\n\n\n\n December 18, 2025 Loly Garcia Tor\n Partner\n loly.tor@klgates.com\n\n By ECF T +1 973 848 4026\n F +1 973 848 4001\n\n Hon. Zahid N. Quraishi, U.S.D.J.\n Clarkson S. Fisher Building & U.S. Courthouse\n 402 East State Street Room 2020\n Trenton, NJ 08608\n\n Re: In re Rocket Pharmaceuticals, Inc. Sec. Litig.,\n Case No. 3:25-cv-10049-ZNQ-TJB\n\n Dear Judge Quraishi:\n\n This firm represents Defendants Rocket Pharmaceuticals, Inc. (\u201cRocket\u201d), Dr. Guarav Shah (\u201cDr.\n Shah\u201d) and Aaron Ondrey (\u201cMr. Ondrey\u201d) (collectively, \u201cDefendants\u201d) in the above-referenced\n action. We write in regard to Your Honor\u2019s December 17, 2025 Text Order (the \u201cText Order\u201d)\n waiving the pre-motion conference for Defendants\u2019 motion to dismiss Plaintiffs\u2019 Consolidated\n Amended Class Action Complaint and setting forth a briefing schedule. (ECF No. 37).\n\n By way of background, on September 22, 2025, Your Honor granted the parties\u2019 Joint Stipulation\n and Scheduling Order (the \u201cJoint Scheduling Order\u201d), which provides that Defendants shall\n answer or move to dismiss Plaintiffs\u2019 Consolidated Amended Class Action Complaint \u201cwithin forty-\n five (45) days of the Court\u2019s holding a pre-motion conference or announcing that it will not do so.\u201d\n (ECF No. 26). The Joint Scheduling Order further grants Lead Plaintiffs 60 days to oppose the\n motion to dismiss and affords Defendants 45 days to reply. (Id.).\n\n We understand the Text Order to trigger the Joint Scheduling Order\u2019s forty-five-day period for\n Defendants to file their motion to dismiss. However, the Text Order sets forth a due date of less\n than forty-five days, January 9, 2025. We respectfully request that the Court strike the January\n 9, 2025 deadline and permit the parties to abide by the deadlines set forth in the Joint Scheduling\n Order.\n\n Pursuant to the Joint Scheduling Order, the deadlines would be as follows:\n\n \u2022 Defendants\u2019 Motion to Dismiss: Due on or before January 31, 2026\n\n \u2022 Plaintiffs\u2019 Opposition: Due on or before April 1, 2026\n\n \u2022 Defendants\u2019 Reply: Due on or before May 16, 2026\n\n SO ORDERED this 19th day of DECEMBER 2025.\n\n s/ Zahid N. Quraishi\n HON. ZAHID N. QURAISHI\nK&L GATES LLP\nONE NEWARK CENTER TENTH FLOOR NEWARK NJ 07102 UNITED STATES DISTRICT COURT\nT +1 973 848 4000 F +1 973 848 4001 klgates.com\n\fCase 3:25-cv-10049-ZNQ-TJB Document 39 Filed 12/19/25 Page 2 of 2 PageID: 632\n\n\n\n\n We thank Your Honor for Your consideration of this request.\n\n Respectfully submitted,\n\n s/ Loly G. Tor\n\n Loly G. Tor\n\n cc: All counsel of record (ECF)\n\n\n\n\n 2\n December 18, 2025\n\f","ocr_status":1,"date_upload":"2026-04-02T08:33:19.401711-07:00","document_number":"39","attachment_number":null,"pacer_doc_id":"119023397226","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Order","acms_document_guid":""}],"date_created":"2025-12-19T08:40:24.045586-08:00","date_modified":"2026-05-29T03:19:40.056910-07:00","date_filed":"2025-12-19","time_filed":"11:27:54","entry_number":39,"recap_sequence_number":"2025-12-19.001","pacer_sequence_number":162,"description":"LETTER ORDER regarding deadline to file motion to dismiss Plaintiffs' Complaint. Signed by Judge Zahid N. Quraishi on 12/19/2025. 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