Material Event (Form 8-K)

On January 20, 2026, BioXcel Therapeutics, Inc. (the "Company") announced the submission on January 14, 2026 of a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") for IGALMI® in the at-home use setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. In April 2022, IGALMI was approved by the FDA as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a healthcare provider. This sNDA submission seeks to expand IGALMI's label to include the broader at home patient population where there are no FDA-approved options currently available.