BioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement

Core Viewpoint - BioXcel Therapeutics, Inc. has received approval from the Nasdaq Hearings Panel to continue its listing on The Nasdaq Stock Market, with a deadline to regain compliance by September 16, 2025 [1][2]. Company Overview - BioXcel Therapeutics is a biopharmaceutical company that leverages artificial intelligence to develop innovative medicines in the field of neuroscience [12]. - The company is also focused on immuno-oncology through its subsidiary, OnkosXcel Therapeutics [12]. Compliance and Listing - The Nasdaq Panel reviewed BioXcel's compliance plan during a hearing on May 1, 2025, and granted an extension for compliance with the MVLS Rule [2]. - The company is committed to executing its compliance plan to meet the necessary requirements within the specified timeframe [2][3]. Product Development - BioXcel is advancing multiple strategic initiatives, including the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501, aimed at supporting a supplemental New Drug Application (sNDA) to expand the IGALMI label [3]. - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently under investigation for treating agitation associated with Alzheimer's dementia and bipolar disorders [4]. SERENITY At-Home Phase 3 Trial - The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in patients with bipolar disorders or schizophrenia [5]. - The trial involves 200 patients self-administering BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout [5]. IGALMI Overview - IGALMI (dexmedetomidine) is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults [6]. - The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose [6]. Safety Information - IGALMI can cause serious side effects, including decreased blood pressure and slower heart rate, particularly in patients with certain pre-existing conditions [7][8]. - Common side effects reported in clinical studies include sleepiness, dizziness, and dry mouth [9].