secwatch.observer — SEC 8-K summary
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Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2025-09-10T23:59:59+00:00
Accession:  0001104659-25-088800
Event type: other_material
Sentiment:  positive
Materiality: 0.88
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel reports positive Phase 3 SERENITY At-Home data for BXCL501; agitation resolution significantly higher vs placebo
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/0001104659-25-088800-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/tm2525736d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-088800

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer