BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®

Core Points - BioXcel Therapeutics is focused on obtaining FDA approval for outpatient use of IGALMI® for treating agitation associated with bipolar disorders or schizophrenia [1][2] - A pre-sNDA meeting with the FDA is scheduled for August 20, 2025, to align on the submission process [2] - The SERENITY At-Home Phase 3 trial is nearing completion, with top-line results expected to be reported this quarter [3] Company Overview - BioXcel Therapeutics, Inc. utilizes artificial intelligence to develop transformative medicines in neuroscience [1][13] - The company has received Breakthrough Therapy designation for BXCL501 for treating agitation associated with dementia and Fast Track designation for schizophrenia and bipolar disorders [5] Clinical Development - The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for acute agitation in the home setting [6] - The trial involves 200 patients with a history of agitation episodes, self-administering the treatment during episodes over a 12-week period [6] Market Opportunity - An estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occur in the at-home setting in the U.S., with no FDA-approved therapies currently available for this treatment [3][17]