{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-088481","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2026-07-30T12:06:08+00:00","discovered_at":"2026-07-30T12:10:01.992257+00:00","generated_at":"2026-07-30T12:10:23.522369+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Replimune presents RP1+nivolumab data at FDA advisory committee for advanced melanoma BLA","bullets":["RP1 (vusolimogene oderparepvec) + nivolumab BLA resubmission discussed at FDA advisory committee on July 30, 2026.","IGNYTE trial ORR 33.6% (95% CI: 25.8-42), CR 16.4%, median DoR 24.8 months in anti-PD-1 failed advanced melanoma.","Safety profile: mainly Grade 1-2, no treatment-related Grade 5 events; 7.9% discontinued RP1 due to TEAE.","FDA clinical review initially recommended accelerated approval; committee to address response assessment and contribution of effect.","Unmet need: only lifileucel (AMTAGVI) approved post anti-PD-1; RP1 offers single-arm data with durable responses."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-088481","json":"https://secwatch.observer/filing/0001104659-26-088481.json","markdown":"https://secwatch.observer/filing/0001104659-26-088481.md","text":"https://secwatch.observer/filing/0001104659-26-088481.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926088481/0001104659-26-088481-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926088481/tm2621663d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-30T12:10:23.522369+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"}