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NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced Tuesday that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its SERENITY At-Home Phase 3 trial without modifications. The company, currently valued at $11 million, has seen its stock decline by 90% over the past year, though InvestingPro analysis indicates it’s trading below its Fair Value.
The recommendation follows a review of unblinded safety data from 178 patients dosed with BXCL501, an investigational treatment for acute agitation associated with bipolar disorders or schizophrenia in at-home settings.
This marks the second positive DSMB recommendation for the trial, which is now fully enrolled with 200 patients. The study is designed as a double-blind, placebo-controlled trial evaluating the safety of a 120 mcg dose of BXCL501 over a 12-week period.
"Bipolar and schizophrenia-related agitation in the at-home setting is a large, unmet medical need, with no FDA-approved therapies," said Vimal Mehta, CEO of BioXcel Therapeutics, in the press release.
The company completed enrollment in May 2025 and expects to release topline data in the third quarter of 2025. If successful, the trial data is intended to support a potential supplemental New Drug Application to expand the label of IGALMI, the FDA-approved formulation of dexmedetomidine sublingual film.
BXCL501 has previously received Breakthrough Therapy designation from the FDA for acute treatment of agitation associated with dementia and Fast Track designation for acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
The trial is collecting safety data and exploratory endpoints to evaluate the treatment’s use in outpatient settings, according to the company statement. With a current ratio of 1.48 and weak overall financial health score, investors can access comprehensive analysis and additional insights through the detailed Pro Research Report available on InvestingPro, which covers over 1,400 US stocks including BioXcel Therapeutics.
In other recent news, BioXcel Therapeutics has made significant strides with its Phase 3 trial of BXCL501, a treatment for acute agitation in patients with bipolar disorders or schizophrenia. The independent Data Safety Monitoring Board recommended the continuation of the SERENITY At-Home trial without modifications after reviewing safety data from the first 115 patients. This pivotal trial is fully enrolled, with over 205 patients having received treatment. In light of these developments, H.C. Wainwright raised its price target for BioXcel to $8, maintaining a Buy rating, citing positive prospects for BXCL501.
Furthermore, BioXcel has been granted an extension by Nasdaq to regain compliance with the Minimum Value of Listed Securities Rule, with a new deadline set for September 16, 2025. The company is also initiating an at-the-market equity offering program, allowing it to sell up to $8,135,000 of its common stock through Canaccord Genuity LLC. This program is designed to provide BioXcel with flexible financing options to support its operations.
The company continues to pursue a supplemental New Drug Application to expand the label of IGALMI, its FDA-approved medication, to include at-home treatment. BioXcel’s strategic moves and ongoing trials underscore its focus on addressing unmet medical needs in the field of neuroscience.
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