---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-121616"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2024-11-21T23:59:59+00:00"
generated_at: "2026-05-29T21:00:31.079296+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Replimune submits BLA for RP1+nivolumab in advanced melanoma under Accelerated Approval; FDA grants Breakthrough Therapy

## Summary
- BLA submitted to FDA for RP1 (vusolimogene oderparepvec) + nivolumab in advanced melanoma patients previously treated with anti-PD1.
- Submission under Accelerated Approval pathway; based on safety and activity in IGNYTE trial.
- FDA granted Breakthrough Therapy designation for RP1 + nivolumab in same setting.
- Confirmatory Phase 3 IGNYTE-3 trial enrolling patients with prior anti-PD1 and anti-CTLA-4 therapy.

## SEC filing metadata
- accession: 0001104659-24-121616
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2024-11-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465924121616/0001104659-24-121616-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465924121616/tm2429181d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-121616
- JSON: https://secwatch.observer/filing/0001104659-24-121616.json
- Plain text: https://secwatch.observer/filing/0001104659-24-121616.txt

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