{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-100605","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2025-10-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.284302+00:00","generated_at":"2026-05-17T03:15:49.432289+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; PDUFA April 10, 2026","bullets":["FDA accepted resubmission of BLA for RP1 plus nivolumab in advanced melanoma patients who progressed on anti-PD-1 therapy.","PDUFA target action date set for April 10, 2026 under Class II resubmission timeline.","Resubmission addresses the complete response letter received in July 2025; includes additional data and analyses.","Replimune CEO expressed commitment to working closely with FDA to expedite review."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-100605","json":"https://secwatch.observer/filing/0001104659-25-100605.json","markdown":"https://secwatch.observer/filing/0001104659-25-100605.md","text":"https://secwatch.observer/filing/0001104659-25-100605.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465925100605/0001104659-25-100605-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465925100605/tm2529069d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:15:49.432289+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"}