1차 출처 기록
결정급PDUFA 날짜 확정
Replimune: FDA가 흑색종 RP1 BLA에 대해 2026년 4월 10일 PDUFA를 설정
The FDA accepted the BLA resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma and assigned a PDUFA target action date of April 10, 2026. Commercial launch preparations are underway pending the outcome of the review.
핵심 사실
출처 발췌
EX-99.1 2 tm264822d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update April 10, 2026 Target Action Date for RP1 in Advanced Melanoma Woburn, MA, February 3, 2026 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update. The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well