{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-420684","form_type":"8-K","ticker":"BMEA","cik":"0001840439","company_name":"Biomea Fusion, Inc.","filed_at":"2026-10-13T21:35:08+00:00","discovered_at":"2026-10-14T10:05:01.238974+00:00","generated_at":"2026-10-14T10:06:15.709956+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Biomea BMF-650 Phase 1: 1.5-3.2% weight loss in Cohorts 1-4 vs 0.1% placebo; Cohort 5 6.1% confounded","bullets":["Mean Day 29 weight reduction 1.5% to 3.2% across MAD Cohorts 1-4 (200 mg+ QD) vs 0.1% pooled placebo; weekly loss ~0.97 kg at 200 mg or higher.","Cohort 5 (200 mg x1 wk then 400 mg x3 wks) showed 6.1% (6.2 kg) mean weight loss at Day 29 but confinement cut placebo food intake to ~33%; results interpreted separately.","Safety: across 5 active MAD cohorts (n=40) all TEAEs mild/moderate; no severe/serious TEAEs, no dose modifications or discontinuations; no ALT/AST increases.","Cohort 5 GI events: nausea and vomiting each 12.5%, constipation 25%, diarrhea 0%; all Grade 1. Across all active cohorts: nausea 17.5%, vomiting 7.5%, constipation 10%, diarrhea 5%.","BMF-650 needs longer-term toxicology studies; Biomea seeks strategic partnership/licensing; primary focus remains icovamenib in type 1 and type 2 diabetes."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-420684","json":"https://secwatch.observer/filing/0001193125-26-420684.json","markdown":"https://secwatch.observer/filing/0001193125-26-420684.md","text":"https://secwatch.observer/filing/0001193125-26-420684.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1840439/000119312526420684/0001193125-26-420684-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1840439/000119312526420684/d158362d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-14T10:06:15.709956+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"}