BioXcel Therapeutics (BTAI) announced the second positive recommendation by an independent Data Safety Monitoring Board to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. The DSMB recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28, 2025 cutoff date. The trial is fully enrolled and collection of data over the 12-week period is continuing. The SERENITY At-Home Phase 3 trial is designed as a double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.Trial enrollment was completed in May. Topline data expected in Q3 2025.
Don’t Miss TipRanks’ Half-Year Sale
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on BTAI:
- BioXcel Therapeutics initiated with a Buy at Lucid Capital
- BioXcel Therapeutics target adjusted to $8 from $3 at H.C. Wainwright
- BioXcel receives positive recommendation from DSMB for SERENITY Phase 3 trial
- BioXcel Granted Nasdaq Compliance Extension Until September
- BioXcel granted extension to regain compliance with Nasdaq listing requirement