BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
BioXcel Therapeutics, Inc. (BTAI)
Last bioxcel therapeutics, inc. earnings: 11/14 07:00 am
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Source: GlobeNewswire
NEW HAVEN, Conn., Jan. 07, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced that it plans to submit a supplemental New Drug Application (sNDA) this month seeking the U.S. Food and Drug Administration’s (FDA) approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. “We are pleased with the progress towards submission of the sNDA and launch planning,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “Based on the accelerated submission timeline, we believe IGALMI could be approved for at-home use as early as 2026. We are now focused on launch planning and look forward to potentially introducing this important treatment option for agitation in the at-home setting, where patients and caregivers need it most and where there are no FDA-approved
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News
- Halper Sadeh LLC Encourages BioXcel Therapeutics, Inc. Shareholders to Contact the Firm to Discuss Their RightsBusiness Wire
- BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting [Yahoo! Finance]Yahoo! Finance
- BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home SettingGlobeNewswire
- BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI® [Yahoo! Finance]Yahoo! Finance
- BioXcel Therapeutics, Inc. (BTAI) Discussion of Managing Acute Agitation in Schizophrenia and Bipolar Disorders at Home Transcript [Seeking Alpha]Seeking Alpha
BTAI
Earnings
- 11/12/25 - Miss
BTAI
Sec Filings
- 1/12/26 - Form 4
- 1/12/26 - Form 4
- 1/12/26 - Form 4
- BTAI's page on the SEC website