{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-079459","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2025-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.773360+00:00","generated_at":"2026-05-17T11:58:01.298898+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"BioXcel receives positive FDA pre-sNDA comments for BXCL501 at-home use; sNDA on track for Q1 2026","bullets":["FDA provided positive written feedback on August 14, 2025 for BXCL501 sNDA in agitation associated with bipolar disorders or schizophrenia for outpatient setting.","Pre-sNDA meeting originally scheduled for August 20, 2025 is cancelled as objectives accomplished based on FDA written responses.","Company believes sNDA regulatory package will be sufficient; submission remains on track for first quarter of 2026.","This expands potential use of BXCL501 (IGALMI) from inpatient to at-home treatment for acute agitation."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-079459","json":"https://secwatch.observer/filing/0001104659-25-079459.json","markdown":"https://secwatch.observer/filing/0001104659-25-079459.md","text":"https://secwatch.observer/filing/0001104659-25-079459.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925079459/0001104659-25-079459-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925079459/tm2523368d4_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:58:01.298898+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"}