BioXcel Therapeutics (NASDAQ: BTAI) has announced new positive Phase 3 SERENITY At-Home data for BXCL501 in agitation associated with bipolar disorders or schizophrenia, to be presented this week at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.
According to BioXcel, the current presentation describes new analyses of exploratory efficacy outcomes from this trial.
In a statement, Dusan Kostic, PhD, SVP, clinical and medical affairs at BioXcel, commented, “These new analyses from the SERENITY At-Home Phase 3 trial further strengthen the growing body of evidence supporting BXCL501 as a potential treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting. If approved, BXCL501 could become the first FDA-approved treatment for acute agitation in the at-home setting, significantly impacting the lives of patients.”
