other material
confidence high
sentiment neutral
materiality 0.55
BioXcel Therapeutics reaches 50% enrollment in SERENITY At-Home Phase 3 trial for BXCL501
BioXcel Therapeutics, Inc.
- 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.