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

Replimune Group, Inc.

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.