{"schema_version":"secwatch.filing_event.v1","accession":"0001935979-25-000080","form_type":"8-K","ticker":"BHVN","cik":"0001935979","company_name":"Biohaven Ltd.","filed_at":"2025-08-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.641119+00:00","generated_at":"2026-05-17T10:40:12.244728+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA cancels advisory committee meeting for Biohaven's troriluzole NDA; decision still Q4 2025","bullets":["FDA informed Biohaven on Aug 21, 2025 that an advisory committee meeting is no longer needed for troriluzole NDA review.","Previously, FDA had extended PDUFA by 3 months (to Q4 2025) and planned an AdComm.","Troriluzole is for treatment of adult Spinocerebellar Ataxia (SCA).","FDA's expected decision remains during Q4 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001935979-25-000080","json":"https://secwatch.observer/filing/0001935979-25-000080.json","markdown":"https://secwatch.observer/filing/0001935979-25-000080.md","text":"https://secwatch.observer/filing/0001935979-25-000080.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1935979/000193597925000080/0001935979-25-000080-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1935979/000193597925000080/bhvn-20250821.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T10:40:12.244728+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"}