{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-043489","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2025-10-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.206056+00:00","generated_at":"2026-05-17T05:03:22.879542+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Vanda reaches FDA framework to resolve disputes on HETLIOZ and tradipitant","bullets":["FDA expedited re-review of tradipitant clinical hold by Nov 26, 2025; PDUFA date Dec 30, 2025.","FDA expedited re-review of HETLIOZ sNDA for jet lag by Jan 7, 2026; Part 12 proceedings paused.","Vanda dismisses two lawsuits: one on tradipitant clinical hold (M.D. Fla.) and one on HETLIOZ info (S.D. Tex.).","Both parties seek temporary pause of tradipitant gastroparesis administrative proceedings until Jan 7, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-043489","json":"https://secwatch.observer/filing/0001628280-25-043489.json","markdown":"https://secwatch.observer/filing/0001628280-25-043489.md","text":"https://secwatch.observer/filing/0001628280-25-043489.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025043489/0001628280-25-043489-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025043489/vnda-20251001.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:03:22.879542+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"}