BioXcel Therapeutics, Inc. (BTAI) Wednesday said that its SERENITY At-Home Phase 3 study evaluating BXCL501, the company's sublingual film formulation of dexmedetomidine, for the acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary goal.
In the study, BXCL501 was well-tolerated in patients with episodes of agitation in the outpatient setting, and no discontinuations for tolerability were observed.
BXCL501 is already approved by the FDA under the brand name IGALMI for the same indication, under healthcare provider supervision.
Base on this data, the company plans to submit sNDA for label expansion of IGALMI in the at-home setting in the first quarter of 2026.
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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.