Moderna 收到 FDA 拒絕受理函，mRNA-1010 季節性流感疫苗申請未獲受理

FDA 的 CBER 於 2026 年 2 月 3 日通知 Moderna，將不會啟動 mRNA-1010 的 BLA 審查，並發出拒絕受理函。此舉中止了該實驗性季節性流感疫苗的監管審查程序。

關鍵事實

申報時間: 2026年2月10日下午11:02
事件: 完整回覆函 (CRL)
方向: 負面
公司: MRNA莫德納
資產: mRNA-1010
來源: SEC 8-K
可信度: 有出處

來源摘錄

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