{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-264447","form_type":"8-K","ticker":"BMEA","cik":"0001840439","company_name":"Biomea Fusion, Inc.","filed_at":"2022-10-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:52.631223+00:00","generated_at":"2026-06-23T03:04:57.007206+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Biomea Fusion announces FDA IND clearance for BMF-219 in KRAS solid tumors; Phase I/Ib trial to begin","bullets":["FDA cleared IND for BMF-219 to initiate Phase I/Ib trial (COVALENT-102) in KRAS-mutant NSCLC, CRC, and PDAC.","BMF-219 is the first menin inhibitor to enter clinical trials for solid tumors.","Preclinical data showed pan-KRAS activity across G12C, G12D, G12V, and G13D mutations.","Company already has COVALENT-101 Phase I trial in blood cancers underway.","KRAS mutations present in 25-35% of NSCLC, 35-45% of CRC, and ~90% of PDAC patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-264447","json":"https://secwatch.observer/filing/0001193125-22-264447.json","markdown":"https://secwatch.observer/filing/0001193125-22-264447.md","text":"https://secwatch.observer/filing/0001193125-22-264447.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1840439/000119312522264447/0001193125-22-264447-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1840439/000119312522264447/d403732d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T03:04:57.007206+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"}