BioXcel Therapeutics

BTAI

Market cap $36.7M

NEW HAVEN, Conn., May 28, 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 presentation of new positive data from the Phase 3 SERENITY At-Home trial evaluating BXCL501 (sublingual dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 26 – 29 in Miami, FL.

BioXcel Therapeutics, Inc. (BTAI) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to a loss of $1.5 per share a year ago.

FDA accepted sNDA for IGALMI® use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date  Advancing BXCL501 as a potential acute treatment for agitation associated with Alzheimer's dementia Evaluating strategic options with an advisor to maximize shareholder value and advance the commercial and development plans for IGALMI NEW HAVEN, Conn., May 15, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today provided a business update and reported financial results for the first quarter of 2026.

BioXcel Therapeutics (BTAI) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

BioXcel Therapeutics, Inc. (BTAI) Discusses Commercial Launch Strategy and Market Opportunity for IGALMI in At-Home Setting Transcript

Live event to be held on Thursday, April 23, at 2:00 p.m. ET  Company focused on advancing launch strategy ahead of November 14 PDUFA target action date NEW HAVEN, Conn.

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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