---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-042141"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2026-04-13T23:59:59+00:00"
generated_at: "2026-05-15T06:35:52.601860+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back

## Summary
- FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
- Without timely accelerated approval, further development of RP1 not viable; company eliminating jobs and scaling back U.S. manufacturing.
- IGNYTE trial: 34% response rate, median duration 24.8 months for RP1 plus nivolumab in patients progressing on anti-PD-1.
- Company cites inconsistent FDA process: new review team, contradictions from September 2025 Type A meeting, and lack of communication.
- Approximately 8,500 advanced melanoma deaths annually in U.S.; CEO says regulatory failure denies patients needed treatment.

## SEC filing metadata
- accession: 0001104659-26-042141
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2026-04-13T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/0001104659-26-042141-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-042141
- JSON: https://secwatch.observer/filing/0001104659-26-042141.json
- Plain text: https://secwatch.observer/filing/0001104659-26-042141.txt

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