{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-042141","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2026-04-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.830380+00:00","generated_at":"2026-05-15T06:35:52.601860+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back","bullets":["FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.","Without timely accelerated approval, further development of RP1 not viable; company eliminating jobs and scaling back U.S. manufacturing.","IGNYTE trial: 34% response rate, median duration 24.8 months for RP1 plus nivolumab in patients progressing on anti-PD-1.","Company cites inconsistent FDA process: new review team, contradictions from September 2025 Type A meeting, and lack of communication.","Approximately 8,500 advanced melanoma deaths annually in U.S.; CEO says regulatory failure denies patients needed treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-042141","json":"https://secwatch.observer/filing/0001104659-26-042141.json","markdown":"https://secwatch.observer/filing/0001104659-26-042141.md","text":"https://secwatch.observer/filing/0001104659-26-042141.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/0001104659-26-042141-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:35:52.601860+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"}