{"schema_version":"secwatch.filing_event.v1","accession":"0001935979-24-000073","form_type":"8-K","ticker":"BHVN","cik":"0001935979","company_name":"Biohaven Ltd.","filed_at":"2024-09-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:15.228368+00:00","generated_at":"2026-05-31T02:33:30.178387+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Biohaven troriluzole pivotal SCA study meets primary endpoint; NDA planned Q4 2024","bullets":["Troriluzole 200 mg once-daily met primary endpoint on f-SARA change from baseline at 3 years in all SCA genotypes.","SCA patients showed 50-70% slower disease progression vs untreated controls, translating to 1.5-2.2 years delay.","Odds ratio for 2+ point f-SARA worsening at 3 years was 4.1 (95% CI: 2.1, 8.1; p<0.0001) favoring troriluzole.","Biohaven to submit NDA to FDA in Q4 2024; eligible for priority review given orphan/fast-track designations.","Company plans US commercialization in 2025 if approved; no FDA-approved treatments currently exist for SCA."],"urls":{"canonical":"https://secwatch.observer/filing/0001935979-24-000073","json":"https://secwatch.observer/filing/0001935979-24-000073.json","markdown":"https://secwatch.observer/filing/0001935979-24-000073.md","text":"https://secwatch.observer/filing/0001935979-24-000073.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1935979/000193597924000073/0001935979-24-000073-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1935979/000193597924000073/bhvn-20240923.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T02:33:30.178387+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"}