Replimune：FDA接受RP1 BLA重新提交，设定2026年4月10日PDUFA日期

FDA已接受RP1联合nivolumab用于晚期黑色素瘤的BLA重新提交，并指定PDUFA目标行动日期为2026年4月10日。该机构认为此次重新提交是对2025年7月21日CRL的完整回应。IGNYTE-3 III期试验仍在进行中，可能支持获批。

关键事实

申报时间: 2025年11月6日 13:20
事件: 申请已受理
方向: 积极
公司: REPLReplimune
资产: vusolimogene oderparepvec
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年8月2日 · 完整回复函 (CRL)

来源摘录

EX-99.1 2 tm2530417d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update Woburn, MA, November 6, 2025 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2025 and provided a business update. The Company announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the BLA resubmission of RP1 for the treatment of advanced melanoma with a Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026. The resubmission is considered by the FDA to be a complete response to the complete respons

SEC 8-K