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BioXcel Therapeutics reports DSMB recommends continuation of SERENITY trial

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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