{"schema_version":"secwatch.filing_event.v1","accession":"0001935979-23-000046","form_type":"8-K","ticker":"BHVN","cik":"0001935979","company_name":"Biohaven Ltd.","filed_at":"2023-07-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.091671+00:00","generated_at":"2026-06-12T23:20:42.185679+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA refuses troriluzole NDA for SCA; BHV-7000 EEG data positive","bullets":["FDA refused to file troriluzole NDA for SCA because primary endpoint not met; company may request Type A meeting within 30 days.","BHV-7000: preliminary EEG data shows target engagement with no somnolence/fatigue; pivotal studies in epilepsy/bipolar disorder planned for 2H2023.","BHV-8000 Phase 1: three dose cohorts dosed, well tolerated, achieved projected therapeutic concentrations; Phase 2 in Parkinson's planned for 2024.","BHV-1300 bispecific IgG degrader advancing to IND in 2H2023; competitive safety and manufacturing profile.","Once-daily extended-release formulation for BHV-7000 confirmed for Phase 2/3 programs."],"urls":{"canonical":"https://secwatch.observer/filing/0001935979-23-000046","json":"https://secwatch.observer/filing/0001935979-23-000046.json","markdown":"https://secwatch.observer/filing/0001935979-23-000046.md","text":"https://secwatch.observer/filing/0001935979-23-000046.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1935979/000193597923000046/0001935979-23-000046-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1935979/000193597923000046/bhvn-20230727.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T23:20:42.185679+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"}