BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting
BioXcel Therapeutics, Inc. (BTAI)
Last bioxcel therapeutics, inc. earnings: 11/14 07:00 am
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Source: GlobeNewswire
sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI® Submission timeline supports potential approval of IGALMI® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI®. The sNDA was submitted on January 14, 2026. In April 2022, IGALMI was approved by the FDA as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the s
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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 Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®GlobeNewswire
BTAI
Earnings
- 11/12/25 - Miss
BTAI
Sec Filings
- 1/20/26 - Form 8-K
- 1/12/26 - Form 4
- 1/12/26 - Form 4
- BTAI's page on the SEC website