---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-100605"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2025-10-20T23:59:59+00:00"
generated_at: "2026-05-17T03:15:49.432289+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; PDUFA April 10, 2026

## Summary
- FDA accepted resubmission of BLA for RP1 plus nivolumab in advanced melanoma patients who progressed on anti-PD-1 therapy.
- PDUFA target action date set for April 10, 2026 under Class II resubmission timeline.
- Resubmission addresses the complete response letter received in July 2025; includes additional data and analyses.
- Replimune CEO expressed commitment to working closely with FDA to expedite review.

## SEC filing metadata
- accession: 0001104659-25-100605
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2025-10-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465925100605/0001104659-25-100605-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465925100605/tm2529069d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-100605
- JSON: https://secwatch.observer/filing/0001104659-25-100605.json
- Plain text: https://secwatch.observer/filing/0001104659-25-100605.txt

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