BioXcel Therapeutics Plans sNDA Submission Seeking FDA Approval for At-Home Use of IGALMI

Reuters01-07

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

BioXcel Therapeutics Inc. has announced plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for at-home use of IGALMI® (dexmedetomidine) sublingual film for the acute treatment of agitation associated with bipolar disorders or schizophrenia. If approved, IGALMI could become the first FDA-approved at-home treatment option for these conditions as early as 2026. The company is now focused on launch planning to address this unmet need for patients and caregivers.

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: 9621217) on January 07, 2026, and is solely responsible for the information contained therein.

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