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October 14, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes

NEW HAVEN, Conn., Oct. 14, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
October 13, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics to Ring Nasdaq Closing Bell on October 14 to Celebrate a Transformative Milestone in Neuroscience Innovation

NEW HAVEN, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company pioneering the use of artificial intelligence to develop transformative...
September 18, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Listed Securities Requirements

NEW HAVEN, Conn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
September 10, 2025 06:30 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia

BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was...
September 04, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference

NEW HAVEN, Conn., Sept. 04, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
August 27, 2025 08:00 ET | Source: BioXcel Therapeutics

UPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for...
August 27, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophreniaNo discontinuations for...
August 26, 2025 16:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics To Announce Topline Results from SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia on August 27, 2025

NEW HAVEN, Conn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
August 19, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Data from more than 2,600 agitation episodes collected Topline data readout is on track for August NEW HAVEN, Conn., Aug. 19, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq:...
August 18, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting sNDA submission on track for Q1 2026 NEW HAVEN, Conn., Aug. 18, 2025 (GLOBE...