{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-108840","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2025-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.251294+00:00","generated_at":"2026-05-16T22:29:16.298718+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BioXcel reports positive Phase 3 safety and efficacy results for BXCL501 agitation in home setting","bullets":["BXCL501 (sublingual dexmedetomidine) safe and well-tolerated in 12-week home-use study (SERENITY At-Home).","No increase in adverse events with repeat dosing; 81% of treated patients completed the study.","Exploratory efficacy: greater reduction in mCGI-S vs placebo (P<0.05); complete resolution higher with BXCL501 (P<.0001).","No patient on active arm discontinued due to TEAE; results support potential label expansion for unsupervised use."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-108840","json":"https://secwatch.observer/filing/0001104659-25-108840.json","markdown":"https://secwatch.observer/filing/0001104659-25-108840.md","text":"https://secwatch.observer/filing/0001104659-25-108840.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925108840/0001104659-25-108840-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925108840/tm2530721d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T22:29:16.298718+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"}