BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company built on artificial intelligence ("AI") to develop transformative medicines in neuroscience, today announced the presentation of new positive data from the Phase 3 SERENITY At-Home trial evaluating BXCL501 (sublingual dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 26 – 29 in Miami, FL.

Positive primary results from the randomized, double-blind, placebo-controlled Phase 3 SERENITY At-Home safety trial have been presented previously. The current presentation describes new analyses of exploratory efficacy outcomes from this trial, which evaluated BXCL501 in patients with agitation associated with bipolar disorders or schizophrenia in the at-home setting. Patients self-administered the study drug during agitation episodes over a 12-week period and assessed symptom severity using the modified Clinical Global Impression-Severity (mCGI-S) scale before dosing and two hours post-dose. The analyses demonstrated that BXCL501 reduced agitation compared to placebo across all levels of baseline symptom severity, including severe, moderate and mild agitation, with the most pronounced treatment effect observed in patients experiencing severe agitation episodes. Importantly, benefit was maintained with repeated dosing throughout the study period regardless of baseline agitation severity.

The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026, for the Company's supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia, which was accepted earlier this year.