{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-010376","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2026-02-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.897531+00:00","generated_at":"2026-05-16T01:05:44.320965+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Vanda Pharmaceuticals receives FDA approval for Bysanti (milsaperidone) for bipolar I disorder and schizophrenia","bullets":["Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.","Bysanti is a new chemical entity that interconverts to iloperidone, leveraging 100,000+ patient-years of real-world experience.","Vanda expects commercial availability in Q3 2026; marketing exclusivity protected by patents expiring in 2044.","This is Vanda's second new drug approval in less than 2 months, following NEREUS in December 2025.","Bysanti is being tested as a once-daily adjunctive for treatment-resistant major depressive disorder, study completion expected by end of 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-010376","json":"https://secwatch.observer/filing/0001628280-26-010376.json","markdown":"https://secwatch.observer/filing/0001628280-26-010376.md","text":"https://secwatch.observer/filing/0001628280-26-010376.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000162828026010376/0001628280-26-010376-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000162828026010376/vnda-20260220.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T01:05:44.320965+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"}