BioXcel Therapeutics (BTAI) announced the second positive recommendation by an independent Data Safety Monitoring Board to continue, without modification, the SERENITY At-Home Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. The recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28, 2025 cutoff date.
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.
Shares of BioXcel Therapeutics are up 7% in pre-market trade on Tuesday.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.