{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-078009","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2026-06-26T12:14:23+00:00","discovered_at":"2026-06-26T12:15:00.337120+00:00","generated_at":"2026-06-26T12:15:08.485268+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; decision by Aug 2","bullets":["FDA accepted as complete, class 1 response; PDUFA goal date August 2, 2026.","Advisory committee meeting expected in late July 2026.","Resubmission based on Phase 2 IGNYTE trial data for RP1 + nivolumab in anti-PD-1 progressed patients.","RP1 (vusolimogene oderparepvec) seeks accelerated approval for advanced melanoma.","CEO notes FDA urgency reflecting significant unmet need and community support."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-078009","json":"https://secwatch.observer/filing/0001104659-26-078009.json","markdown":"https://secwatch.observer/filing/0001104659-26-078009.md","text":"https://secwatch.observer/filing/0001104659-26-078009.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926078009/0001104659-26-078009-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926078009/tm2619037d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T12:15:08.485268+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"}