{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-157310","form_type":"8-K","ticker":"BMEA","cik":"0001840439","company_name":"Biomea Fusion, Inc.","filed_at":"2024-06-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:20.659734+00:00","generated_at":"2026-06-01T05:41:17.706984+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA places full clinical hold on Biomea Fusion's BMF-219 diabetes trials due to liver enzyme elevations","bullets":["Full clinical hold on Phase I/II COVALENT-111 and COVALENT-112 for BMF-219 in type 2 and type 1 diabetes.","FDA cited potential drug-induced hepatotoxicity; higher doses up to 400 mg may have contributed to liver enzyme elevations.","Most adverse events mild to moderate; no serious adverse reactions reported to date with BMF-219.","Company continues data collection during hold; collaborating with FDA to resolve clinical hold quickly."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-157310","json":"https://secwatch.observer/filing/0001193125-24-157310.json","markdown":"https://secwatch.observer/filing/0001193125-24-157310.md","text":"https://secwatch.observer/filing/0001193125-24-157310.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1840439/000119312524157310/0001193125-24-157310-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1840439/000119312524157310/d94044d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T05:41:17.706984+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"}