{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-098149","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2024-09-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.262871+00:00","generated_at":"2026-05-31T05:55:37.315606+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"BioXcel submits Phase 3 protocol for BXCL501 in Alzheimer's agitation to FDA","bullets":["Submitted TRANQUILITY In-Care Phase 3 protocol for 60 mcg BXCL501 to FDA on Sept 5, 2024.","Trial targets agitation associated with Alzheimer's dementia.","No additional details on trial design or timeline were disclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-098149","json":"https://secwatch.observer/filing/0001104659-24-098149.json","markdown":"https://secwatch.observer/filing/0001104659-24-098149.md","text":"https://secwatch.observer/filing/0001104659-24-098149.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465924098149/0001104659-24-098149-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465924098149/tm2423619d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T05:55:37.315606+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"}