{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-062241","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2024-03-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:23.885968+00:00","generated_at":"2026-06-05T01:18:05.474905+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA issues Complete Response Letter for Vanda's HETLIOZ insomnia sNDA","bullets":["Received CRL on March 4, 2024 for HETLIOZ (tasimelteon) to treat insomnia with sleep initiation difficulties.","FDA stated deficiencies precluding approval; sNDA cannot be approved in present form.","Vanda reviewing CRL and evaluating next steps; no specific financial impact disclosed.","PDUFA date was March 4, 2024; FDA had flagged deficiencies on February 4, 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-062241","json":"https://secwatch.observer/filing/0001193125-24-062241.json","markdown":"https://secwatch.observer/filing/0001193125-24-062241.md","text":"https://secwatch.observer/filing/0001193125-24-062241.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524062241/0001193125-24-062241-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524062241/d764198d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T01:18:05.474905+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"}