{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-001766","form_type":"8-K","ticker":"BCAX","cik":"0002023658","company_name":"Bicara Therapeutics Inc.","filed_at":"2026-01-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:37.018701+00:00","generated_at":"2026-05-16T10:58:25.406434+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":"Bicara selects 1500 mg ficerafusp alfa dose for Phase 3 pivotal HNSCC study","bullets":["Selected 1500 mg QW ficerafusp alfa plus pembrolizumab as optimal dose for Phase 3 FORTIFI-HN01 in 1L HPV-negative R/M HNSCC.","Expects substantial enrollment by end-2026 to enable interim analysis mid-2027 for potential accelerated filing.","Plans to present Phase 1b expansion data in 1L HNSCC (Q1 2026) and long-term follow-up (Q2 2026).","Will explore ficerafusp alfa in other solid tumors; Phase 1b mCRC data expected H2 2026.","Planning critical commercial hires in 2026, including Chief Commercial Officer, to prepare for launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-001766","json":"https://secwatch.observer/filing/0001628280-26-001766.json","markdown":"https://secwatch.observer/filing/0001628280-26-001766.md","text":"https://secwatch.observer/filing/0001628280-26-001766.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/0001628280-26-001766-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/bcax-20260112.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T10:58:25.406434+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"}