{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-055393","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2025-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.206634+00:00","generated_at":"2026-05-16T14:34:11.200357+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":"FDA lifts partial clinical hold on Vanda's tradipitant for motion sickness","bullets":["FDA lifted partial clinical hold on protocol VP-VLY-686-3403, removing the 90-dose cap on tradipitant studies.","Lift followed Vanda's formal dispute resolution and expedited re-review under October 2025 collaborative framework.","FDA agreed motion sickness is acute, event-driven; no additional dog toxicity study required.","NDA for tradipitant to prevent vomiting due to motion remains under review; PDUFA date December 30, 2025.","CEO Mihael Polymeropoulos thanked FDA for swift scientific review and constructive dialogue."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-055393","json":"https://secwatch.observer/filing/0001628280-25-055393.json","markdown":"https://secwatch.observer/filing/0001628280-25-055393.md","text":"https://secwatch.observer/filing/0001628280-25-055393.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/0001628280-25-055393-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/vnda-20251204.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:34:11.200357+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"}