On April 1, 2026, BioXcel Therapeutics, Inc. (the "Company") announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI^. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026.