BioXcel Therapeutics Inc. (NASDAQ:BTAI) experienced significant after-hours momentum, jumping 19.09% to $6.24 in the after-hours trading session on Tuesday, as investors got ready for the release of important clinical trial results.
Check out the current price of BTAI stock here.
Conference Call Triggers Investor Interest
The biopharmaceutical company announced it will host an investor call today at 8 a.m. ET to review topline results from its SERENITY At-Home Pivotal Phase 3 safety trial. The study evaluates BXCL501, a proprietary sublingual film formulation of dexmedetomidine, for treating agitation associated with bipolar disorders or schizophrenia in at-home settings.
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According to Benzinga Pro data, BTAI closed regular trading at $5.24 on Tuesday, representing a 1.55% daily gain before the after-hours surge. 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.
Trial Design and Market Implications
The SERENITY trial 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.
FDA Designations Support Development Path
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.
With a strong Momentum in the 87th percentile, Benzinga’s Edge Stock Rankings indicate that BTAI has a positive price trend across all time frames. Track the performance of other players in this segment.
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