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.
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