{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-183710","form_type":"8-K","ticker":"BMEA","cik":"0001840439","company_name":"Biomea Fusion, Inc.","filed_at":"2026-04-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.088892+00:00","generated_at":"2026-05-15T03:10:15.260088+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":"Biomea Fusion reports Phase 2 COVALENT-112 positive topline: 52% C-peptide increase in early T1D","bullets":["In patients diagnosed within 3 years, icovamenib 200mg QD for 12 weeks increased mean C-peptide AUC by 52% (p<0.001, n=5) at Week 12; effect sustained with ~7% decline from baseline at Week 52.","Dose response observed; longer-standing T1D (3-15 years) preserved C-peptide through Week 52 with only modest decline.","Company plans Phase 2 trial with extended dosing (6-12 months) plus immunosuppressant, to start H2 2026 at four U.S. academic centers.","Study enrollment interrupted due to FDA clinical hold (resolved); data reflects about half intended population; no placebo control completed.","Icovamenib generally well tolerated; comprehensive data to be presented at ADA Scientific Sessions in June 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-183710","json":"https://secwatch.observer/filing/0001193125-26-183710.json","markdown":"https://secwatch.observer/filing/0001193125-26-183710.md","text":"https://secwatch.observer/filing/0001193125-26-183710.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1840439/000119312526183710/0001193125-26-183710-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1840439/000119312526183710/d142809d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T03:10:15.260088+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"}