{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-024112","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2024-02-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:23.885322+00:00","generated_at":"2026-06-06T09:00:39.701694+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA identifies deficiencies in Vanda's sNDA for HETLIOZ insomnia; Vanda alleges FDCA violation","bullets":["FDA notified Vanda on Feb 4, 2024 of deficiencies in sNDA for HETLIOZ (tasimelteon) for insomnia; no details disclosed.","Vanda claims FDA violated FDCA by missing statutory deadline of Oct 31, 2023, to approve or provide a hearing.","sNDA submitted May 4, 2023; PDUFA target date was March 4, 2024; deficiencies preclude labeling discussions.","Vanda is also challenging FDA approvals of generic HETLIOZ, which have been marketed since 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-024112","json":"https://secwatch.observer/filing/0001193125-24-024112.json","markdown":"https://secwatch.observer/filing/0001193125-24-024112.md","text":"https://secwatch.observer/filing/0001193125-24-024112.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524024112/0001193125-24-024112-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000119312524024112/d772316d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T09:00:39.701694+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"}