secwatch.observer — SEC 8-K summary
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Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2025-03-21T23:59:59+00:00
Accession:  0001104659-25-026388
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel Therapeutics reaches 50% enrollment in SERENITY At-Home Phase 3 trial for BXCL501
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- 100 patients enrolled out of 200 expected (50% of total); 24 sites open as of March 20, 2025.
- Trial evaluates BXCL501 (sublingual dexmedetomidine film) for acute agitation in bipolar disorder or schizophrenia at home.
- Topline data expected in second half of 2025 to support sNDA for expanded IGALMI label.
- Enrollment began September 2024; no safety or efficacy results reported yet.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925026388/0001104659-25-026388-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925026388/tm259958d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-026388

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