---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-091066"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2025-09-18T23:59:59+00:00"
generated_at: "2026-05-17T06:16:06.639768+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "medium"
source: SEC EDGAR
---

# Replimune completes Type A FDA meeting for RP1 BLA in melanoma; path forward uncertain

## Summary
- Completed Type A FDA meeting on Sept 16, 2025 regarding CRL for RP1+nivolumab BLA in advanced melanoma.
- Evaluating FDA feedback; accelerated approval path not yet determined.
- CEO cites unmet need and compelling IGNYTE trial risk-benefit; committed to working with FDA.
- No timeline or resolution provided; stock may remain volatile pending updates.

## SEC filing metadata
- accession: 0001104659-25-091066
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2025-09-18T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: medium
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465925091066/0001104659-25-091066-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465925091066/tm2526397d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-091066
- JSON: https://secwatch.observer/filing/0001104659-25-091066.json
- Plain text: https://secwatch.observer/filing/0001104659-25-091066.txt

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