{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-121616","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2024-11-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.411997+00:00","generated_at":"2026-05-29T21:00:31.079296+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Replimune submits BLA for RP1+nivolumab in advanced melanoma under Accelerated Approval; FDA grants Breakthrough Therapy","bullets":["BLA submitted to FDA for RP1 (vusolimogene oderparepvec) + nivolumab in advanced melanoma patients previously treated with anti-PD1.","Submission under Accelerated Approval pathway; based on safety and activity in IGNYTE trial.","FDA granted Breakthrough Therapy designation for RP1 + nivolumab in same setting.","Confirmatory Phase 3 IGNYTE-3 trial enrolling patients with prior anti-PD1 and anti-CTLA-4 therapy."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-121616","json":"https://secwatch.observer/filing/0001104659-24-121616.json","markdown":"https://secwatch.observer/filing/0001104659-24-121616.md","text":"https://secwatch.observer/filing/0001104659-24-121616.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465924121616/0001104659-24-121616-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465924121616/tm2429181d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T21:00:31.079296+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"}