{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-068948","form_type":"8-K","ticker":"REPL","cik":"0001737953","company_name":"Replimune Group, Inc.","filed_at":"2024-06-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.825017+00:00","generated_at":"2026-06-01T05:57:21.612846+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Replimune reports positive IGNYTE primary analysis: ORR 33.6% in anti-PD1 failed melanoma; BLA submission planned 2H2024","bullets":["Primary analysis shows ORR 33.6% (modified RECIST 1.1) and 32.9% (RECIST 1.1) by independent central review; all responses >6 months, median DOR >35 months.","BLA submission intended for 2H2024; confirmatory IGNYTE-3 trial first patient expected Q3 2024.","Safety: predominantly Grade 1-2 constitutional events; no Grade 5 events; low incidence of Grade 3-4 incidents.","Data improves on investigator-assessed results presented at ASCO 2024; FDA-requested RECIST 1.1 analysis included."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-068948","json":"https://secwatch.observer/filing/0001104659-24-068948.json","markdown":"https://secwatch.observer/filing/0001104659-24-068948.md","text":"https://secwatch.observer/filing/0001104659-24-068948.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1737953/000110465924068948/0001104659-24-068948-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1737953/000110465924068948/tm2416613d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T05:57:21.612846+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"}