---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-068002"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2026-05-29T13:56:10+00:00"
generated_at: "2026-05-29T13:57:13.665470+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Replimune to resubmit RP1 BLA for advanced melanoma; FDA agrees to prioritize review

## Summary
- Company will resubmit BLA in coming days after collaborative FDA dialogue aligns on path forward.
- FDA will treat resubmission as urgent matter and prioritize review due to high unmet need.
- Approximately 8,500 Americans with advanced melanoma die each year; half fail checkpoint inhibitor therapy.
- BLA supported by IGNYTE trial data in patients who progressed on anti-PD-1 therapy.
- CEO Sushil Patel expressed gratitude to FDA for commitment to supporting patients and innovation.

## SEC filing metadata
- accession: 0001104659-26-068002
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2026-05-29T13:56:10+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465926068002/0001104659-26-068002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465926068002/tm2615980d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-068002
- JSON: https://secwatch.observer/filing/0001104659-26-068002.json
- Plain text: https://secwatch.observer/filing/0001104659-26-068002.txt

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