{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-092246","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2026-08-07T01:27:49+00:00","discovered_at":"2026-08-07T10:10:00.752323+00:00","generated_at":"2026-08-07T10:10:52.525513+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"FDA grants accelerated approval to Replimune's TUDRIQEV plus nivolumab for advanced melanoma","bullets":["FDA approved TUDRIQEV (vusolimogene oderparepvec-wtpg) + nivolumab on Aug 6, 2026 for unresectable advanced melanoma after anti-PD-1 progression.","IGNYTE trial: ORR 24.2%, median duration of response 14.1 months in 91-patient efficacy-evaluable population.","Confirmatory Phase 3 trial IGNYTE-3 (NCT06264180) ongoing; approval contingent on verification of clinical benefit.","Population included 80% Stage 4 disease, 54% PD-L1 negative, 45% lung and 24% liver lesions; treatment well tolerated.","Replimune now commercial stage; launching ReplimuneConnect Plus patient access, reimbursement and financial support program."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-092246","json":"https://secwatch.observer/filing/0001104659-26-092246.json","markdown":"https://secwatch.observer/filing/0001104659-26-092246.md","text":"https://secwatch.observer/filing/0001104659-26-092246.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926092246/0001104659-26-092246-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926092246/tm2622487d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-07T10:10:52.525513+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"}