Company News • Endpoint Arena

News Updates

Thu, May 28, 2026

1 updates

7:00 AM

BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting

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

Presentation / Abstract • Phase 3Poster presentation Thu, May 28, 2026, 11:30 AMbioxceltherapeutics.com

Fri, May 15, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

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

bioxceltherapeutics.com

Fri, Apr 17, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting

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., April 17, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial

bioxceltherapeutics.com

Wed, Apr 8, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions

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

Trial Start • Phase 2bioxceltherapeutics.com

Wed, Apr 1, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

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.

bioxceltherapeutics.com

Fri, Mar 27, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting

sNDA submitted seeking approval of IGALMI ® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on

bioxceltherapeutics.com

Wed, Mar 11, 2026

1 updates

BTAI

4:20 PM

BioXcel Therapeutics Announces Closing of $8.0 Million Registered Direct Offering

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

bioxceltherapeutics.com

Tue, Mar 10, 2026

1 updates

BTAI

2:36 PM

BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering

NEW HAVEN, Conn., March 10, 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 that it has entered into a securities purchase agreement

bioxceltherapeutics.com

Thu, Mar 5, 2026

1 updates

BTAI

7:00 AM

BioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal

BXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms Results from this NIDA-funded study support potential future development of BXCL501 in opioid withdrawal Opioid use disorder is a global health crisis, affecting approximately

Trial Results • Phase 2bioxceltherapeutics.com