{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-311217","form_type":"8-K","ticker":"COGT","cik":"0001622229","company_name":"Cogent Biosciences, Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.951943+00:00","generated_at":"2026-05-16T13:58:33.644520+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Cogent reports positive SUMMIT and APEX trial results for bezuclastinib in mastocytosis","bullets":["SUMMIT Part 2: mean TSS change -24.3 (-43%) vs placebo -15.4 (-29%), p<0.001; 34.3% vs 18.1% had >=50% TSS reduction (p=0.01).","SUMMIT: 87.4% had >=50% serum tryptase reduction; 75.6% had >=50% bone marrow mast cell reduction (p<0.001 vs placebo).","APEX Part 2 top-line: 57% ORR (CR+CRh+PR+CI) per mIWG criteria; 80% ORR per pure pathological response.","APEX: 89% had >=50% serum tryptase reduction; 91% had >=50% KIT D816V VAF reduction; no discontinuations due to TRAEs.","Cogent expects to submit NDA for bezuclastinib in AdvSM to FDA in H1 2026; detailed APEX data at scientific meeting H1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-311217","json":"https://secwatch.observer/filing/0001193125-25-311217.json","markdown":"https://secwatch.observer/filing/0001193125-25-311217.md","text":"https://secwatch.observer/filing/0001193125-25-311217.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1622229/000119312525311217/0001193125-25-311217-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1622229/000119312525311217/d81277d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:58:33.644520+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"}