{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-088800","form_type":"8-K","ticker":"BTAI","cik":"0001720893","company_name":"BioXcel Therapeutics, Inc.","filed_at":"2025-09-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.773936+00:00","generated_at":"2026-05-17T07:02:16.434116+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.88,"calibrated_materiality_score":0.88,"confidence":"high","headline":"BioXcel reports positive Phase 3 SERENITY At-Home data for BXCL501; agitation resolution significantly higher vs placebo","bullets":["SERENITY At-Home trial: 246 patients randomized; BXCL501 showed significant mean reduction in mCGI-S score vs placebo at 2 hours (p<.05).","Complete resolution of agitation in 50% of BXCL501 arm vs 33% placebo overall (p<.0001); severe episodes resolved 61% vs 18% (p<.0001).","Efficacy maintained across repeated dosing and over 12-week duration; mean reduction of 1.2-1.4 in mCGI-S score.","Company revises addressable market estimate to 57-77M agitation episodes annually (from prior 23M) based on trial and survey data.","BXCL501 (IGALMI) is already FDA-approved for medically supervised settings; data supports potential label expansion for at-home use."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-088800","json":"https://secwatch.observer/filing/0001104659-25-088800.json","markdown":"https://secwatch.observer/filing/0001104659-25-088800.md","text":"https://secwatch.observer/filing/0001104659-25-088800.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/0001104659-25-088800-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/tm2525736d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T07:02:16.434116+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"}