---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-078009"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2026-06-26T12:14:23+00:00"
generated_at: "2026-06-26T12:15:08.485268+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; decision by Aug 2

## Summary
- FDA accepted as complete, class 1 response; PDUFA goal date August 2, 2026.
- Advisory committee meeting expected in late July 2026.
- Resubmission based on Phase 2 IGNYTE trial data for RP1 + nivolumab in anti-PD-1 progressed patients.
- RP1 (vusolimogene oderparepvec) seeks accelerated approval for advanced melanoma.
- CEO notes FDA urgency reflecting significant unmet need and community support.

## SEC filing metadata
- accession: 0001104659-26-078009
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2026-06-26T12:14:23+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/1737953/000110465926078009/0001104659-26-078009-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465926078009/tm2619037d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-078009
- JSON: https://secwatch.observer/filing/0001104659-26-078009.json
- Plain text: https://secwatch.observer/filing/0001104659-26-078009.txt

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