BioXcel Therapeutics, Inc.·Healthcare

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DoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially impact Veteran Affairs/Department of War Clinical Practice Guidelines for management of acute stress reactions (ASR) NEW HAVEN, Conn., April 08, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the enrollment of the first patients in a U.S. Department of War (DoW)-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions (ASR), also known as acute stress disorder (ASD).

PDUFA target action date of November 14, 2026 Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting NEW HAVEN, Conn., April 01, 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 the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.

sNDA submitted seeking approval of IGALMI® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia

HARTFORD, Conn., March 23, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP announces that the United States District Court for the District of Connecticut has approved the following announcement of a proposed class action settlement that would benefit purchasers of BioXcel Therapeutics, Inc. securities (NASDAQ: BTAI):

NEW HAVEN, Conn., March 11, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience, today announced the closing of its previously announced registered direct offering of 4,500,785 shares (the “Shares”) of common stock, par value $0.001 per share (“Common Stock”) (or common stock equivalents in lieu thereof), and accompanying warrants (the “Accompanying Warrants”) to purchase up to 4,500,785 shares of Common Stock at a combined offering price of $1.739 per Share (or per common stock equivalent in lieu thereof) and Accompanying Warrant. The Accompanying Warrants have an exercise price of $1.614 per share of Common Stock, are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expire five years from the date of issuance.
BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The company's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. Its commercial product, IGALMI (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The company also continues to conduct clinical trials evaluating BXCL501 for the treatment of agitation in Alzheimer's disease patients, and for adjunctive treatment of patients with major depressive disorder, as well as in the community for agitation associated with bipolar disorders and schizophrenia. In addition, it is developing BXCL502 as a potential therapy for chronic agitation in dementia; and BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. The company was incorporated in 2017 and is headquartered in New Haven, Connecticut.
Healthcare
Biotechnology
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2018-03-08
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