NEW HAVEN, Conn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with the market value of listed securities (“MVLS”) requirement under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”). As ...

Core Insights - BioXcel Therapeutics announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501, indicating significant benefits in treating agitation associated with bipolar disorders and schizophrenia [1][3][5] Efficacy Results - BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) [6] - Complete resolution of agitation symptoms was significantly higher with BXCL501 compared to placebo, with an overall resolution of 50% in the BXCL501 arm versus 33% on placebo (p <.0001) [7] - The mean reduction in mCGI-S score was maintained across repeated dosing, with a mean reduction of 1.2 after the first 12 doses and 1.4 after 13 or more doses [8] - The reduction in agitation symptoms was consistent throughout the 12-week trial duration, with a mean reduction of 1.3 in mCGI-S scores across all weeks [9] Trial Design and Patient Insights - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients, with data collected on 2,628 agitation episodes over 12 weeks [4][16] - The trial included patients with bipolar disorders (45%) and schizophrenia (55%), allowing for concomitant interventions to manage agitation episodes [4] - Patients reported an average of 11.7 agitation episodes during the trial, with 81% completing the full 12-week study [4] Market Opportunity - The total addressable market for at-home agitation treatment is estimated to be significantly higher than previously anticipated, with 57-77 million agitation episodes annually compared to an earlier estimate of 23 million [12] - The lack of FDA-approved therapies for at-home agitation treatment highlights a substantial unmet need in the market [11][12] Future Plans - Based on the positive trial results and FDA feedback, the company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded usage of IGALMI® in outpatient settings [1][2][10]

Core Insights - BioXcel Therapeutics announced that BXCL501 achieved its primary endpoint in the SERENITY At-Home trial, demonstrating good tolerability for treating agitation in patients with bipolar disorders or schizophrenia at home [1][2][3] - The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded use of BXCL501 in outpatient settings without healthcare provider supervision [1][2][3] - The SERENITY At-Home trial treated over 2400 episodes of agitation, indicating a significant market opportunity for BXCL501 [1][2][3] Company Overview - BioXcel Therapeutics is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [2][26] - BXCL501 is a proprietary sublingual film formulation of dexmedetomidine, currently FDA-approved for use in medically supervised settings [19][20] - The company aims to change the treatment paradigm for agitation associated with bipolar disorders and schizophrenia, addressing a significant unmet medical need in the at-home setting [3][14] Trial Details - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients over 12 weeks, evaluating the safety of a 120 mcg dose of BXCL501 [3][18] - The trial reported that 168 patients (81%) completed the full 12-week duration, with an average of 11.7 agitation episodes recorded per treated patient [6][9] - No discontinuations due to tolerability were reported in the BXCL501 arm, and the adverse event profile was consistent with the approved IGALMI® label [9][10] Market Insights - Previous estimates suggested 23 million annual episodes of agitation, but new data indicates the total addressable market could be significantly higher, with estimates of 57 million to 77 million episodes annually in the at-home setting [15][22] - Market research suggests that episodes may occur 3-4 times a month on average, with most being moderate or severe [15][22] - Physicians believe there is a significant unmet need for effective and fast-acting treatments for agitation in the community setting [22] Future Plans - BioXcel plans to leverage the positive results from the SERENITY At-Home trial to support its regulatory submission for BXCL501, aiming to provide patients with access to treatment in the home setting [3][13] - The company will continue to analyze the full dataset from the trial and present additional results at upcoming medical meetings and conferences [16][12]