Replimune 計劃在與 FDA 達成共識後重新提交 RP1 BLA

Replimune 與 FDA 已就 RP1 BLA 在晚期黑色素瘤的重新提交達成共識。公司將在未來幾天內重新提交申請，FDA 已表示將把此次重新提交視為緊急事項並優先審查。

關鍵事實

申報時間: 2026年5月29日下午01:56
事件: 申請已送件
方向: 正面
公司: REPLReplimune
資產: vusolimogene oderparepvec
來源: SEC 8-K
可信度: 有出處

來源摘錄

EX-99.1 2 tm2615980d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) - Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmi

SEC 8-K