---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-005291"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2025-01-22T23:59:59+00:00"
generated_at: "2026-05-27T20:01:48.025591+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Replimune BLA for RP1+nivolumab in advanced melanoma accepted with Priority Review; PDUFA July 22, 2025

## Summary
- FDA accepted BLA for RP1 (vusolimogene oderparepvec) plus nivolumab for advanced melanoma; granted Priority Review.
- PDUFA action date set for July 22, 2025; no advisory committee meeting currently planned.
- BLA supported by primary analysis from IGNYTE trial in anti-PD-1 failed melanoma patients.
- Confirmatory Phase 3 IGNYTE-3 trial ongoing with over 100 planned sites globally.
- Replimune previously received Breakthrough Therapy designation for this combination.

## SEC filing metadata
- accession: 0001104659-25-005291
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2025-01-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465925005291/0001104659-25-005291-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465925005291/tm254066d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-005291
- JSON: https://secwatch.observer/filing/0001104659-25-005291.json
- Plain text: https://secwatch.observer/filing/0001104659-25-005291.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.