---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-092246"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2026-08-07T01:27:49+00:00"
generated_at: "2026-08-07T10:10:52.525513+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# FDA grants accelerated approval to Replimune's TUDRIQEV plus nivolumab for advanced melanoma

## Summary
- FDA approved TUDRIQEV (vusolimogene oderparepvec-wtpg) + nivolumab on Aug 6, 2026 for unresectable advanced melanoma after anti-PD-1 progression.
- IGNYTE trial: ORR 24.2%, median duration of response 14.1 months in 91-patient efficacy-evaluable population.
- Confirmatory Phase 3 trial IGNYTE-3 (NCT06264180) ongoing; approval contingent on verification of clinical benefit.
- Population included 80% Stage 4 disease, 54% PD-L1 negative, 45% lung and 24% liver lesions; treatment well tolerated.
- Replimune now commercial stage; launching ReplimuneConnect Plus patient access, reimbursement and financial support program.

## SEC filing metadata
- accession: 0001104659-26-092246
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2026-08-07T01:27:49+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465926092246/0001104659-26-092246-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465926092246/tm2622487d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-092246
- JSON: https://secwatch.observer/filing/0001104659-26-092246.json
- Plain text: https://secwatch.observer/filing/0001104659-26-092246.txt

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