---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-069489"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2025-07-22T23:59:59+00:00"
generated_at: "2026-05-18T04:23:45.690336+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Replimune receives FDA Complete Response Letter for RP1 BLA in advanced melanoma

## Summary
- FDA issues CRL for RP1 + nivolumab; IGNYTE trial deemed not adequate/well-controlled.
- CRL cites heterogeneous patient population and need to address confirmatory trial design.
- No safety issues raised; Company requests Type A meeting within 30 days.
- CEO surprised as issues not raised during mid- or late-cycle reviews.
- Without accelerated approval, RP1 development for advanced melanoma patients not viable.

## SEC filing metadata
- accession: 0001104659-25-069489
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2025-07-22T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465925069489/0001104659-25-069489-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465925069489/tm2521403d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-069489
- JSON: https://secwatch.observer/filing/0001104659-25-069489.json
- Plain text: https://secwatch.observer/filing/0001104659-25-069489.txt

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