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

Core Insights - BioXcel Therapeutics, Inc. will host an investor call on August 27, 2025, to review topline data from the SERENITY At-Home Pivotal Phase 3 trial for BXCL501, aimed at treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][2] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that leverages artificial intelligence to develop transformative medicines in neuroscience [11] - The company’s subsidiary, OnkosXcel Therapeutics, focuses on immuno-oncology [11] SERENITY At-Home Phase 3 Trial - The trial involved 200 patients with agitation episodes despite stable treatment for bipolar disorder or schizophrenia, requiring self-administration of 120 mcg of BXCL501 or placebo during episodes over a 12-week period [3] - Safety data was collected, and patients or caregivers completed a modified global impression of severity (mCGIs) two hours post-dosing as an exploratory endpoint [3] Product Information - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently approved for use under medical supervision as IGALMI for acute treatment of agitation associated with schizophrenia and bipolar disorder [4][5] - BXCL501 is also being investigated for agitation associated with Alzheimer's dementia and has received Breakthrough Therapy and Fast Track designations from the FDA for various indications [4] Upcoming Events - The topline data from the SERENITY trial will be disseminated in a press release and presented during the investor call/webcast [2]