{"schema_version":"secwatch.filing_event.v1","accession":"0001935979-26-000077","form_type":"8-K","ticker":"BHVN","cik":"0001935979","company_name":"Biohaven Ltd.","filed_at":"2026-09-10T01:55:18+00:00","discovered_at":"2026-09-10T10:05:00.506829+00:00","generated_at":"2026-09-10T10:05:23.956742+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA partial clinical hold on BHV-7000 pauses new enrollment; dosing continues","bullets":["FDA issued partial clinical hold letter Sept 4, 2026, pausing new patient enrollment pending nonclinical metabolite data.","Dosing continues for >600 already randomized patients; BHV7000-303 fully enrolled, topline on track for H2 2026.","BHV7000-302 new enrollment paused; open-label extension continues dosing; global sites voluntarily paused outside U.S.","Over 1,200 participants dosed to date; metabolite findings may be rodent-specific and of uncertain human relevance.","Aug 26, 2026 license agreement with SK Biopharmaceuticals for Kv7 platform incl. BHV-7000; HSR submission pending."],"urls":{"canonical":"https://secwatch.observer/filing/0001935979-26-000077","json":"https://secwatch.observer/filing/0001935979-26-000077.json","markdown":"https://secwatch.observer/filing/0001935979-26-000077.md","text":"https://secwatch.observer/filing/0001935979-26-000077.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/0001935979-26-000077-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-10T10:05:23.956742+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"}