---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-025680"
form_type: "8-K"
ticker: "REPL"
cik: "0001737953"
company_name: "Replimune Group, Inc."
filed_at: "2023-02-27T23:59:59+00:00"
generated_at: "2026-06-18T23:50:41.438663+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Replimune provides FDA update on CERPASS trial; no changes to protocol or endpoints

## Summary
- FDA agreed no changes to CERPASS clinical trial protocol or data analysis plan after meeting.
- Minor changes to statistical analysis plan (SAP) unrelated to dual primary endpoints (ORR and CRR).
- Company still expects BLA submission for RP1 in early 2024, assuming positive data and overall clinical benefit.
- This update follows FDA response to draft SAP submitted in September 2022.

## SEC filing metadata
- accession: 0001104659-23-025680
- form_type: 8-K
- ticker: REPL
- cik: 0001737953
- company_name: Replimune Group, Inc.
- filed_at: 2023-02-27T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737953/000110465923025680/0001104659-23-025680-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737953/000110465923025680/tm237904d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-025680
- JSON: https://secwatch.observer/filing/0001104659-23-025680.json
- Plain text: https://secwatch.observer/filing/0001104659-23-025680.txt

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