原始来源记录

决策级申请已提交

Rocket Pharmaceuticals撤回Fanconi贫血症RP-L102的BLA

Rocket于2025年10月3日自愿撤回其美国mozafancogene autotemcel(RP-L102)的BLA。此次撤回是在2025年7月决定停止新的内部投资以及此前撤回欧洲MAA之后采取的行动。该举措是战略性的,并不反映安全性或有效性问题;公司保留通过外部合作重新与监管机构接触的选项。

关键事实

申报时间
2025年10月3日 11:02
事件
申请已提交
方向
消极
来源
SEC 8-K
可信度
有来源

来源摘录

false 0001281895 0001281895 2025-10-03 2025-10-03 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 3, 2025 Rocket Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-36829 04-3475813 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 9 Cedarbrook Drive , Cranbury , NJ 08512 ( Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 646 ) 440-9100 Not applicable (Former name or former address, if changed since last report) Check the appropriate box below if t

SEC 8-K