{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-221784","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2024-09-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.744470+00:00","generated_at":"2026-05-31T03:32:30.890685+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues Complete Response Letter declining Vanda's tradipitant NDA for gastroparesis","bullets":["FDA declined to approve tradipitant for gastroparesis on Sept 18, 2024; issued CRL citing need for additional studies.","FDA action was delayed by over 185 days, Vanda says fails requirements of FDCA.","Vanda believes application met substantial evidence standard and plans to continue pursuing approval.","Separate NDA for tradipitant in prevention of vomiting from motion sickness planned later this year.","Expanded access program continues for several dozen gastroparesis patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-221784","json":"https://secwatch.observer/filing/0001193125-24-221784.json","markdown":"https://secwatch.observer/filing/0001193125-24-221784.md","text":"https://secwatch.observer/filing/0001193125-24-221784.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524221784/0001193125-24-221784-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524221784/d809647d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T03:32:30.890685+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"}