Moderna 收到 FDA 关于 mRNA-1010 季节性流感疫苗的拒绝受理函

FDA 的 CBER 于 2026 年 2 月 3 日通知 Moderna，将不会启动 mRNA-1010 的 BLA 审查，并发出了拒绝受理函。这将暂停该在研季节性流感疫苗的监管审查流程。

关键事实

申报时间: 2026年2月10日 23:02
事件: 完整回复函 (CRL)
方向: 消极
公司: MRNA莫德纳
资产: mRNA-1010
来源: SEC 8-K
可信度: 有来源

来源摘录

mrna-20260203 0001682852 false 0001682852 2026-02-03 2026-02-03 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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): February 3, 2026 MODERNA, INC. (Exact name of registrant as specified in its charter) Delaware 001-38753 81-3467528 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 325 Binney Street Cambridge , MA 02142 (Address of principal executive offices) (Zip code) Registrant’s telephone number, including area code: ( 617 ) 714-6500 Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K fi

SEC 8-K