---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-123459"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2023-12-05T23:59:59+00:00"
generated_at: "2026-06-07T18:06:28.335561+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Replimune CERPASS trial misses primary endpoints; BLA for RP1 in melanoma planned 2H 2024

## Summary
- CERPASS trial of RP1+cemiplimab in CSCC did not meet primary endpoints; CRR 38.1% vs 25% (p=0.040 just below threshold).
- In anti-PD1 failed melanoma (IGNYTE, n=156), ORR 31.4% (12% CR); median DOR >24 months; BLA submission planned for 2H 2024.
- RP1 monotherapy (ARTACUS) in transplant patients: 34.8% ORR, 5 CRs, no allograft rejection.
- Portfolio reprioritization: discontinue RP2/3 in SCCHN/CRC and RP3 development; focus on RP1 melanoma and RP2 uveal melanoma.
- Cash $496.8M as of Sept 30, 2023; cash runway extended into early 2026.

## SEC filing metadata
- accession: 0001104659-23-123459
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2023-12-05T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465923123459/0001104659-23-123459-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465923123459/tm2332152d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-123459
- JSON: https://secwatch.observer/filing/0001104659-23-123459.json
- Plain text: https://secwatch.observer/filing/0001104659-23-123459.txt

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