BioXcel Therapeutics Plans sNDA Submission for IGALMI At-Home Use

Reuters01-12

BioXcel <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Plans sNDA Submission for IGALMI At-Home Use

BioXcel Therapeutics Inc. announced that it is on track to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The company expects to submit the sNDA this month, with the potential for FDA approval and an at-home launch of IGALMI® as early as year-end 2026.

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: 9623592) on January 12, 2026, and is solely responsible for the information contained therein.

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