{"schema_version":"secwatch.filing_event.v1","accession":"0001599298-26-000081","form_type":"8-K","ticker":"SMMT","cik":"0001599298","company_name":"Summit Therapeutics Inc.","filed_at":"2026-09-15T12:44:39+00:00","discovered_at":"2026-09-15T12:50:00.376922+00:00","generated_at":"2026-09-15T12:50:23.783507+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Summit reports consistent OS benefit for ivonescimab in HARMONi; HARMONi-2 OS data positive","bullets":["Updated HARMONi OS analysis: global ITT HR 0.76 (95% CI 0.61-0.95; p=0.0151), median OS 16.8 vs 14.0 months.","Western subgroup OS HR 0.76 (95% CI 0.52-1.10), consistent with global; median follow-up 23.2 months.","HARMONi-2 (Akeso-sponsored) OS: HR 0.73 (95% CI 0.57-0.95; p=0.009) vs pembrolizumab; median OS 30.8 vs 22.6 months.","No new safety signals; BLA PDUFA date for ivonescimab is November 14, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001599298-26-000081","json":"https://secwatch.observer/filing/0001599298-26-000081.json","markdown":"https://secwatch.observer/filing/0001599298-26-000081.md","text":"https://secwatch.observer/filing/0001599298-26-000081.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1599298/000159929826000081/0001599298-26-000081-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1599298/000159929826000081/smmt-20260915.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-15T12:50:23.783507+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"}