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결정급신청 제출
Replimune, FDA와의 합의 후 RP1 BLA 재제출 계획
Replimune과 FDA는 진행성 흑색종에 대한 RP1 BLA 재제출을 위한 경로에 합의했습니다. 회사는 수일 내에 신청서를 재제출할 예정이며, FDA는 재제출을 긴급 사안으로 처리하고 검토를 우선시할 것이라고 밝혔습니다.
핵심 사실
출처 발췌
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