# Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma
Canonical URL: https://biopharmsignal.com/news/REPL/replimune-announces-fda-acceptance-of-bla-resubmission-of-rp1-for-the-treatment-of-advanced-melanoma
Ticker: REPL
Company: Replimune Group
Source: Replimune Group
Published: 2025-10-20 11:00 EST
Original Source URL: https://ir.replimune.com
## Summary

Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026 WOBURN, Mass. , Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the

## Article Body
Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026 WOBURN, Mass. , Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the
## Recent Company News
- 2026-05-31 12:00 EST — [Replimune Presents Final First-in-Human Data for RP2 in Advanced Solid Tumors During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting](https://biopharmsignal.com/news/REPL/replimune-presents-final-first-in-human-data-for-rp2-in-advanced-solid-tumors-during-oral-presentation-at-the-2026-american-society-of-clinical-oncology-annual-meeting) — Source: Replimune Group
- 2026-05-30 12:00 EST — [Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting](https://biopharmsignal.com/news/REPL/replimune-presents-3-year-landmark-overall-survival-analysis-from-ignyte-clinical-trial-during-oral-presentation-at-the-2026-american-society-of-clinical-oncology-annual-meeting) — Source: Replimune Group
- 2026-05-29 12:00 EST — [Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA](https://biopharmsignal.com/news/REPL/replimune-announces-planned-rp1-bla-resubmission-following-productive-discussion-with-fda) — Source: Replimune Group
- 2026-04-27 12:00 EST — [Replimune to Present at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting](https://biopharmsignal.com/news/REPL/replimune-to-present-at-the-2026-american-society-of-clinical-oncology-asco-annual-meeting) — Source: Replimune Group
- 2026-04-10 21:02 EST — [Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma](https://biopharmsignal.com/news/REPL/replimune-receives-complete-response-letter-from-the-fda-for-rp1-biologics-license-application-for-the-treatment-of-advanced-melanoma) — Source: Replimune Group
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