BioXcel Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IGALMI® (dexmedetomidine) sublingual film, seeking label expansion for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. The submission is supported by results from the Phase 3 SERENITY At-Home safety trial, which demonstrated that IGALMI was well-tolerated with a safety profile consistent with its currently approved label. Pending FDA review, potential approval of this label expansion could occur as early as year-end 2026. No other beneficiary organizations were mentioned in connection with this regulatory submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioXcel Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9628338-en) on January 20, 2026, and is solely responsible for the information contained therein.