{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-097127","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2024-09-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.262585+00:00","generated_at":"2026-05-31T06:15:55.711243+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"BioXcel initiates patient enrollment in pivotal Phase 3 SERENITY At-Home trial for BXCL501","bullets":["Phase 3 trial evaluates safety of 120 mcg BXCL501 (dexmedetomidine ODF) for acute agitation in bipolar or schizophrenia in the at-home setting.","Double-blind, placebo-controlled study will enroll ~200 patients; patients self-administer drug/placebo over 12-week period.","Primary objective is safety; exploratory endpoint modified CGI-C two hours after dosing; trial duration expected 9–12 months.","No changes to guidance or financial outlook; company previously disclosed substantial doubt about going concern."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-097127","json":"https://secwatch.observer/filing/0001104659-24-097127.json","markdown":"https://secwatch.observer/filing/0001104659-24-097127.md","text":"https://secwatch.observer/filing/0001104659-24-097127.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465924097127/0001104659-24-097127-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465924097127/tm2423413d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T06:15:55.711243+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"}