公司诉讼案件 - Rocket Pharmaceuticals因涉嫌违反《1934年证券交易法》被提起集体诉讼，指控公司在2025年2月27日至5月26日期间向投资者提供有关RP-A501治疗Danon疾病的2期关键试验的材料信息时，同时传播了 materially false and misleading statements 和/或隐瞒了 material adverse facts，特别是公司知道 Serious Adverse Events（包括研究参与者的死亡）是一个风险 [1][4] - 公司被指控在未向股东提供关键更新的情况下，修改了试验方案，引入了一种 novel immunomodulatory agent 到预处理方案中 [4] - 2025年5月27日，公司宣布美国食品药品监督管理局对RP-A501的2期关键研究实施了临床 hold，原因是至少一名患者在试验中遭受了 Serious Adverse Event 并最终死亡，而公司在管理层做出修订时未向投资者披露这一实质性修订 [5] 公司业务 - Rocket Pharmaceuticals是一家专注于开发罕见和毁灭性疾病基因疗法的 late-stage biotechnology company [3] 律师事务所信息 - Robbins Geller Rudman & Dowd LLP 是一家代表投资者处理证券欺诈和股东诉讼的世界领先律师事务所，在过去五年中有四年在ISS Securities Class Action Services排名中位列第一，2024年为投资者追回了超过25亿美元的证券相关集体诉讼赔偿 [7]

SAN FRANCISCO, June 12, 2025 (GLOBE NEWSWIRE) -- A securities class action lawsuit styled Ho v. Rocket Pharmaceuticals, Inc., et al., No. 3:25-cv-10049 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired Rocket Pharmaceuticals securities between February 27, 2025 and May 26, 2025. The lawsuit comes after investors saw the price of their shares in Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) crash over 60% on May 27, 2025 as a result of the company’s announcement that ...

NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of New Jersey on behalf of all persons or entities who purchased or otherwise acquired Rocket Pharmaceuticals, Inc. (“Rocket Pharmaceuticals” or the “Company”) (NASDAQ: RCKT) securities between February 27, 2025 and May 26, 2025, both dates inclusive (the “Class Period”). The Complaint alleges that Defendants provided overw ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Rocket Pharmaceuticals To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 in Rocket Pharmaceuticals between February 27, 2025 and May 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW ...

SAN DIEGO, June 12, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Rocket Pharmaceuticals, Inc. (NYSE: RCKT) securities between February 7, 2025 and May 26, 2025. Rocket is a fully integrated, late-stage biotechnology company focused on the development of gene therapies, with direct on-target mechanism of action and clear clinical endpoints, for rare and devastating diseases.For more information, submit a form, e ...

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- The following statement is being issued by Levi & Korsinsky, LLP: To: All persons or entities who purchased or otherwise acquired securities of Rocket Pharmaceuticals, Inc. (“Rocket” or the “Company”) (NASDAQ: RCKT) between February 27, 2025, to May 26, 2025, both dates inclusive. You are hereby notified that the class action lawsuit Rondolph Ho v. Rocket Pharmaceuticals, Inc., et al. (Case No. 3:25-cv-10049) has been commenced in the United States District Court ...

报告公司投资评级 - 报告将Rocket Pharmaceuticals Inc.的评级从“Neutral”下调至“Sell”，12个月目标价从13美元降至2美元 [2] 报告的核心观点 - FDA对Rocket Pharmaceuticals Inc.的2期Danon病试验实施临床搁置，影响RP - A501商业潜力和可治疗市场规模的确定性，公司修改方案暗示研究关键治疗阶段存在安全问题，RP - A501未来发展充满挑战 [1][2] - 考虑对A501获批可能性及监管/商业时间表的潜在影响，下调评级并降低目标价 [2] 根据相关目录分别进行总结 临床搁置事件 - 5月27日公司宣布FDA于5月23日对2期Danon病试验实施临床搁置，5月初治疗的一名患者在RP - A501给药约1周后出现毛细血管渗漏综合征，后发展为急性全身感染死亡，公司认为可能与使用C3抑制剂有关，另一名使用该抑制剂的患者也出现此综合征，但公司及时干预并停用 [1] 模型变化 - 降低RP - A501的Danon病收入预测，包括将获批概率降至20%（原65%），降低美国和欧盟的峰值份额，推迟美国和欧盟的上市时间 [3] - 提高加权平均资本成本至19%（原18%），降低早期管线收入 [3] 投资者电话会议要点 - FDA将发送正式询问清单，公司仍致力于推进Danon病项目，将修改/简化免疫调节方案，可能用C5抑制剂替代C3抑制剂，研究超募患者，公司进行内部战略审查并将现金跑道指引延长至2027年 [6] 积极因素 - RP - A501临床搁置快速解决、开发时间表明确、免疫抑制方案改善，验证公司对Danon病在美国和欧盟的患病率估计，LAD - I和FA项目获批 [10] 未来12个月事件 - AAV心血管项目（DD、PKP2 - ACM、BAG3 - DCM）和LV血液学项目（LAD - I、FA、PKD）有相关进展 [11] 估值 - 基于DCF方法，不考虑并购，假设加权平均资本成本19%和终端增长率1%，得出12个月目标价2美元 [12] 关键上行风险 - Danon病临床搁置解决、RP - A601的1期研究有有利长期临床数据、RCKT的AAV9 - BAG3项目有积极初始临床数据、RP - A501和其他管线资产有更大可寻址市场机会、后期资产有有利报销/定价决策 [13] 财务数据对比 - 产品预测中RP - A501新老模型收入差异大，损益预测中收入、毛利率、营业利润率、净利润等指标新老模型也有不同程度变化 [8]

LOS ANGELES, May 29, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Rocket Pharmaceuticals, Inc. (“Rocket” or “the Company”) (NASDAQ: RCKT) investors that the firm has initiated an investigation into possible securities fraud and may file a class action on behalf of investors. Rocket investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: info@portnoylaw.com, to discuss ...

NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Rocket Pharmaceuticals, Inc. (“Rocket” or the “Company”) (NASDAQ: RCKT).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Rocket and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Ma ...

核心事件 - Rocket Pharmaceuticals基因疗法RP-A501在关键II期研究中出现患者死亡事件 导致公司股价单日暴跌62.8% [1] - 患者死因系急性全身感染 属于非预期的严重不良事件 [1] - 公司已自愿暂停研究给药 美国FDA已对该研究实施临床暂停 [2] 应对措施 - 公司正进行全面的根本原因分析以确定不良事件原因 [2] - 与FDA、独立数据安全监测委员会及临床研究者合作 争取尽快重启研究 [3] - 管理层强调RP-A501是首个在心血管疾病临床研究中显示安全性和有效性的基因疗法 [3] 股价表现 - 公司年初至今股价累计下跌81.5% 远超行业同期5.8%的跌幅 [4] 研发管线挫折 - 治疗LAD-I的Kresladi去年6月收到FDA完全回应函(CRL) [5] - FDA要求提供有限的化学制造与控制(CMC)补充信息 [7] - 这是FDA第二次要求Kresladi的CMC信息 2024年2月曾延长审批期三个月 [7] - 公司计划2025年重新提交完整BLA以解决CRL问题 [8] 同业公司表现 - Lexicon Pharmaceuticals(LXRX)2025年每股亏损预估从0.37美元收窄至0.32美元 年初股价下跌6.6% [10] - Chemomab Therapeutics(CMMB)2025年每股亏损预估从0.70美元收窄至0.60美元 年初股价下跌22.7% [11] - Amarin(AMRN)2025年每股亏损预估从5.33美元大幅收窄至3.48美元 年初股价上涨17.1% [12]