{"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","discovered_at":"2026-05-14T18:03:46.358129+00:00","generated_at":"2026-06-18T23:50:41.438663+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Replimune provides FDA update on CERPASS trial; no changes to protocol or endpoints","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-025680","json":"https://secwatch.observer/filing/0001104659-23-025680.json","markdown":"https://secwatch.observer/filing/0001104659-23-025680.md","text":"https://secwatch.observer/filing/0001104659-23-025680.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-18T23:50:41.438663+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}