{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-055287","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2025-03-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.403834+00:00","generated_at":"2026-05-24T15:19:20.806684+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Vanda announces FDA accepted tradipitant NDA for motion sickness; PDUFA Dec 30, 2025; firm criticizes timeline","bullets":["FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.","Vanda says FDA intends to take 12 months for review, 6 months beyond the statutory deadline, calling it a violation of the FD&C Act.","Clinical data from pooled studies (681 subjects): vomiting in 14.6% (170 mg) and 18.9% (85 mg) vs 41.2% placebo, p<0.0001.","Vanda publicly criticized the FDA as 'broken and unaccountable' for allegedly stifling innovation and delaying approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-055287","json":"https://secwatch.observer/filing/0001193125-25-055287.json","markdown":"https://secwatch.observer/filing/0001193125-25-055287.md","text":"https://secwatch.observer/filing/0001193125-25-055287.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/0001193125-25-055287-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/d938957d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T15:19:20.806684+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"}