{"schema_version":"secwatch.filing_event.v1","accession":"0001935979-25-000056","form_type":"8-K","ticker":"BHVN","cik":"0001935979","company_name":"Biohaven Ltd.","filed_at":"2025-05-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.505424+00:00","generated_at":"2026-05-21T05:55:23.608260+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA extends Biohaven's troriluzole PDUFA date to 4Q 2025, plans advisory committee meeting","bullets":["FDA extends PDUFA date by 3 months to 4Q 2025 for troriluzole NDA for spinocerebellar ataxia (SCA).","FDA plans to hold an advisory committee meeting to discuss the application; no date set.","FDA did not raise new concerns; mid-cycle review found no major safety issues and no REMS needed.","Troriluzole has Fast-Track, Orphan Drug, and Priority Review status; would be first approved SCA treatment.","Clinical data showed 50-70% slowing of disease progression and reduced fall risk in SCA."],"urls":{"canonical":"https://secwatch.observer/filing/0001935979-25-000056","json":"https://secwatch.observer/filing/0001935979-25-000056.json","markdown":"https://secwatch.observer/filing/0001935979-25-000056.md","text":"https://secwatch.observer/filing/0001935979-25-000056.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1935979/000193597925000056/0001935979-25-000056-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1935979/000193597925000056/bhvn-20250514.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T05:55:23.608260+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"}