---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-088481"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2026-07-30T12:06:08+00:00"
generated_at: "2026-07-30T12:10:23.522369+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Replimune presents RP1+nivolumab data at FDA advisory committee for advanced melanoma BLA

## Summary
- RP1 (vusolimogene oderparepvec) + nivolumab BLA resubmission discussed at FDA advisory committee on July 30, 2026.
- IGNYTE trial ORR 33.6% (95% CI: 25.8-42), CR 16.4%, median DoR 24.8 months in anti-PD-1 failed advanced melanoma.
- Safety profile: mainly Grade 1-2, no treatment-related Grade 5 events; 7.9% discontinued RP1 due to TEAE.
- FDA clinical review initially recommended accelerated approval; committee to address response assessment and contribution of effect.
- Unmet need: only lifileucel (AMTAGVI) approved post anti-PD-1; RP1 offers single-arm data with durable responses.

## SEC filing metadata
- accession: 0001104659-26-088481
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2026-07-30T12:06:08+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465926088481/0001104659-26-088481-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465926088481/tm2621663d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-088481
- JSON: https://secwatch.observer/filing/0001104659-26-088481.json
- Plain text: https://secwatch.observer/filing/0001104659-26-088481.txt

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