BioXcel Therapeutics Surges 19% After Hours on Clinical Trial Results

BioXcel Therapeutics Inc. (BTAI) stock surged 19% in after-hours trading, driven by the announcement of topline results from its SERENITY At-Home Pivotal Phase 3 safety trial. The trial evaluates BXCL501, a sublingual film formulation of dexmedetomidine, for treating agitation associated with bipolar disorders or schizophrenia. The stock has faced significant volatility over the past year, trading within a range of $1.17 to $13.36, with a current market capitalization of $73.62 million.

BioXcel Therapeutics Inc. (BTAI) stock experienced significant after-hours momentum, surging 19.09% to $6.24, following the announcement of topline results from its SERENITY At-Home Pivotal Phase 3 safety trial. The trial evaluates BXCL501, a proprietary sublingual film formulation of dexmedetomidine, for treating agitation associated with bipolar disorders or schizophrenia in at-home settings [1].

The biopharmaceutical company, based in Connecticut, will host an investor call today at 8 a.m. ET to review the trial results. The study followed 200 patients with bipolar disorder or schizophrenia who used BXCL501 or a placebo during agitation episodes over 12 weeks, focusing mainly on safety. The Connecticut-based company’s existing approved product, IGALMI® (dexmedetomidine) sublingual film, already treats agitation under medical supervision. Expanding to at-home use represents a significant market opportunity for the neuroscience-focused company [1].

BXCL501 has received Breakthrough Therapy designation from the FDA for acute agitation treatment in dementia and Fast Track designation for schizophrenia, bipolar disorders, and dementia applications. These regulatory pathways could accelerate approval timelines if trial results prove positive. The company leverages artificial intelligence to identify new therapeutic indications for existing approved drugs, positioning it within the growing precision medicine sector focused on neuroscience applications [1].

The stock has faced significant volatility over the past year, trading within a range of $1.17 to $13.36, with a current market capitalization of $73.62 million and an average volume of 17.17 million shares [1]. The strong momentum in the 87th percentile indicates a positive price trend across all time frames [1].

References:
[1] https://www.benzinga.com/markets/equities/25/08/47350864/bioxcel-stock-surges-19-in-after-hours-trading-what-you-need-to-know
[2] https://www.stocktitan.net/news/BTAI/bio-xcel-therapeutics-to-announce-topline-results-from-serenity-at-1rgy1omou6ip.html