UPDATE: BioXcel Therapeutics Inc. (BTAI) is experiencing a dramatic surge in stock price, soaring 19.09% to $6.24 in after-hours trading as of Tuesday evening. This surge comes as investors eagerly anticipate crucial results from the company’s pivotal clinical trial.
BioXcel has just announced it will host an investor call today at 8 a.m. ET to discuss the topline results from its SERENITY At-Home Pivotal Phase 3 safety trial. This study focuses on BXCL501, a proprietary sublingual film formulation of dexmedetomidine, aimed at treating agitation associated with bipolar disorders and schizophrenia within at-home settings.
The excitement around BTAI is palpable, especially after the stock closed regular trading at $5.24, reflecting a modest 1.55% daily gain prior to the after-hours spike. This notable increase is part of a larger trend, as the stock has shown significant volatility over the past year, trading between $1.17 and $13.36, with a current market capitalization of $73.62 million.
The SERENITY trial evaluated 200 patients suffering from bipolar disorder or schizophrenia, administering either BXCL501 or a placebo during agitation episodes over a span of 12 weeks. The primary goal of this trial is to assess safety, marking a critical step for the Connecticut-based company.
BioXcel’s existing product, IGALMI® (dexmedetomidine) sublingual film, is already approved for treating agitation under medical supervision. The potential expansion of BXCL501 to at-home use presents a significant market opportunity for the neuroscience-focused company, addressing a pressing need for effective management of agitation in patients outside clinical settings.
Furthermore, BXCL501 has garnered Breakthrough Therapy designation from the FDA for acute agitation treatment in dementia, along with Fast Track designation for applications related to schizophrenia and bipolar disorders. These regulatory designations could expedite the approval process if the trial results are favorable.
The company leverages artificial intelligence to identify new therapeutic indications for existing drugs, positioning itself at the forefront of the precision medicine sector focused on neuroscience applications. With momentum in the 87th percentile, according to Benzinga’s Edge Stock Rankings, BTAI is showing a positive price trend across all time frames.
Investors are advised to track this developing story closely as the results from the SERENITY trial may significantly impact BioXcel’s future trajectory.
Stay tuned for more updates as the investor call unfolds and further details emerge from BioXcel Therapeutics.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors. Benzinga does not provide investment advice. All rights reserved.
