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May 28, 2026 07:00 ET | Source: BioXcel Therapeutics

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...
May 15, 2026 07:00 ET | Source: BioXcel Therapeutics

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...
March 27, 2026 07:00 ET | Source: BioXcel Therapeutics

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...
November 12, 2025 07:00 ET | Source: BioXcel Therapeutics

BioXcel Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on Late-Stage Clinical Programs for Agitation in Bipolar, Schizophrenia, and Alzheimer’s Disease

NEW HAVEN, Conn., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in...
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...
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...
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:...