{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-091066","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2025-09-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.843480+00:00","generated_at":"2026-05-17T06:16:06.639768+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"medium","headline":"Replimune completes Type A FDA meeting for RP1 BLA in melanoma; path forward uncertain","bullets":["Completed Type A FDA meeting on Sept 16, 2025 regarding CRL for RP1+nivolumab BLA in advanced melanoma.","Evaluating FDA feedback; accelerated approval path not yet determined.","CEO cites unmet need and compelling IGNYTE trial risk-benefit; committed to working with FDA.","No timeline or resolution provided; stock may remain volatile pending updates."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-091066","json":"https://secwatch.observer/filing/0001104659-25-091066.json","markdown":"https://secwatch.observer/filing/0001104659-25-091066.md","text":"https://secwatch.observer/filing/0001104659-25-091066.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465925091066/0001104659-25-091066-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465925091066/tm2526397d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:16:06.639768+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"}