{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-004787","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2026-01-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.000339+00:00","generated_at":"2026-05-16T09:34:11.788992+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BioXcel submits sNDA for at-home use of IGALMI for agitation in bipolar/schizophrenia","bullets":["Submitted sNDA to FDA on January 14, 2026 for IGALMI in the at-home setting.","IGALMI currently approved only under healthcare provider supervision since April 2022.","No FDA-approved at-home options exist for acute agitation in bipolar disorders or schizophrenia.","Seeking to expand IGALMI's label to cover broader at-home patient population."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-004787","json":"https://secwatch.observer/filing/0001104659-26-004787.json","markdown":"https://secwatch.observer/filing/0001104659-26-004787.md","text":"https://secwatch.observer/filing/0001104659-26-004787.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/0001104659-26-004787-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/tm263511d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T09:34:11.788992+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"}