BioXcel Therapeutics' Igalmi Shows Significant Efficacy in At-Home Setting for Schizophrenia and Bipolar Disorder Patients

BioXcel Therapeutics reported topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, showing that BXCL501 had continued effects and consistent benefit with repeat dosing for agitation associated with bipolar disorders or schizophrenia. The trial demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours. Patients experienced a complete resolution of agitation symptoms measured by mCGI-S at significantly higher rates with BXCL501 compared to placebo across the severity of agitation episodes.