BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

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NEW HAVEN, Conn., Jan. 07, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a bio...

Corporate Developments

The article outlines significant corporate developments that may lead to FDA drug approval, crucial for BTAI's financial prospects and an increase in patient population. Positive regulatory news often correlates directly with stock performance, positioning this as an impactful development.

FAQ

Why Bullish?

The planned sNDA for at-home use may increase patient access and sales potential, similar to how competitive edge gained in prior FDA approvals led to stock price increases. Historical precedents, such as when Rhopio's home-use approval led to a significant stock surge, bolster this outlook.

How important is it?

The article outlines significant corporate developments that may lead to FDA drug approval, crucial for BTAI's financial prospects and an increase in patient population. Positive regulatory news often correlates directly with stock performance, positioning this as an impactful development.

Why Short Term?

An upcoming sNDA submission and potential 2026 approval create immediate market interest. Rapid market response to drug approvals typically generates short-term stock fluctuations.

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BioXcel Therapeutics Plans Submission for IGALMI® Approval for At-Home Use

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company specializing in AI-driven neuroscience medicines, has announced plans to submit a supplemental New Drug Application (sNDA) this month. This submission seeks U.S. Food and Drug Administration (FDA) approval for the at-home use of IGALMI®, targeting the acute treatment of agitation associated with bipolar disorders or schizophrenia.

Accelerated Approval Timeline

Chief Executive Officer Vimal Mehta, Ph.D., expressed optimism about the upcoming submission. “We are pleased with the progress towards submission of the sNDA and launch planning,” stated Dr. Mehta. “Based on the accelerated submission timeline, we believe IGALMI could be approved for at-home use as early as 2026.”

This submission marks a significant step as patients and caregivers currently lack FDA-approved treatment options for managing agitation in an at-home setting.

Overview of IGALMI® and BXCL501

IGALMI® is a sublingual film formulation of dexmedetomidine, an investigational drug designed for the acute treatment of agitation associated with psychiatric disorders. Outside its approved indication, BioXcel is investigating BXCL501 for treating agitation related to Alzheimer’s dementia, bipolar I or II disorder, and schizophrenia at home.

Indication: Acute treatment of agitation in bipolar and schizophrenia disorders.
Formulation: Sublingual film.
FDA Designations: Breakthrough Therapy and Fast Track for multiple indications.

The efficacy and safety of BXCL501 for these investigational uses have yet to be established. However, the drug has received significant regulatory designations, reflecting its potential in the field.

Important Safety Information

IGALMI® is associated with certain risks, including:

Decreased blood pressure and slower heart rate.
Potential heart rhythm changes (QT interval prolongation).
Sleepiness or drowsiness, advising against activities requiring mental alertness.

Patients are recommended to remain hydrated and sit or lie down post-administration and must consult healthcare providers regarding any side effects or medical history that could heighten risks when using IGALMI.

About BioXcel Therapeutics

BioXcel Therapeutics, Inc. operates with a mission to innovate within neuroscience using artificial intelligence. Its subsidiary, OnkosXcel Therapeutics, concentrates on developing immune-oncology medicines. BioXcel leverages data and machine learning to repurpose existing drugs for new therapeutic uses.

For further information, visit bioxceltherapeutics.com, and review safety information at Igalmi.com.

Forward-Looking Statements

This announcement contains forward-looking statements regarding BioXcel’s expectations about development timelines, the commercialization of IGALMI®, and other strategic objectives. These statements are subject to various risks and uncertainties, and actual results may differ significantly.