Rocket Pharmaceuticals 撤回 Fanconi 貧血症 RP-L102 的 BLA

Rocket 於 2025 年 10 月 3 日自願撤回 mozafancogene autotemcel (RP-L102) 的美國 BLA。此舉繼 2025 年 7 月決定停止新的內部投資以及先前撤回歐洲 MAA 之後。該行動屬策略性，並非反映安全性或有效性問題；公司保留透過外部合作重新與監管機構接洽的選項。

關鍵事實

申報時間: 2025年10月3日上午11:02
事件: 申請已送件
方向: 負面
公司: RCKTRocket Pharmaceuticals
資產: mozafancogene autotemcel
來源: SEC 8-K
可信度: 有出處

來源摘錄

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