{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-086031","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2024-04-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.036709+00:00","generated_at":"2026-06-04T02:47:04.743392+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vanda's Fanapt receives FDA approval for bipolar I disorder indication","bullets":["FDA approved Fanapt (iloperidone) on April 2, 2024 for acute treatment of manic or mixed episodes in bipolar I disorder in adults.","Approval based on pivotal study of ~400 patients; primary endpoint YMRS at Week 4 highly statistically significant (p=0.000008).","Fanapt was previously approved for schizophrenia in 2009; safety profile consistent across indications.","Vanda CEO cites significant increase in commercial opportunity; bipolar I disorder affects ~10M Americans."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-086031","json":"https://secwatch.observer/filing/0001193125-24-086031.json","markdown":"https://secwatch.observer/filing/0001193125-24-086031.md","text":"https://secwatch.observer/filing/0001193125-24-086031.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524086031/0001193125-24-086031-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524086031/d819383d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T02:47:04.743392+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"}