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NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), currently valued at $82 million in market capitalization, announced Tuesday it has completed the database lock for its SERENITY At-Home pivotal Phase 3 safety trial evaluating BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. According to InvestingPro data, the company’s stock has shown significant volatility, with a remarkable 138% surge over the past six months despite recent market pressures.
The company expects to release topline results from the study later this month, with its next earnings report scheduled for November 12. The trial collected data from more than 2,600 agitation episodes across over 200 patients at 22 clinical sites nationwide. InvestingPro analysis indicates the company faces financial challenges, with current liquid assets falling short of short-term obligations and a negative EBITDA of -$49.85 million in the last twelve months.
"The database lock is a significant step forward," said Vimal Mehta, CEO of BioXcel Therapeutics, in a press release statement.
The double-blind, placebo-controlled study was designed to evaluate the safety of a 120 mcg dose of BXCL501 in the at-home setting. Patients self-administered either BXCL501 or placebo during agitation episodes over a 12-week period.
The trial enrolled a balanced distribution of patients with bipolar disorders and schizophrenia, with no single site enrolling more than 11% of the total patient population. The company reported that the vast majority of enrolled patients completed the full study duration. For investors seeking deeper insights, InvestingPro offers 10+ additional exclusive tips and comprehensive analysis through its Pro Research Report, available for over 1,400 US stocks including BTAI.
BXCL501 has received Fast Track Designation from the FDA for the acute treatment of agitation associated with bipolar disorders or schizophrenia. Currently, there are no FDA-approved therapies for acute treatment of agitation in the at-home setting.
BioXcel partnered with Worldwide Clinical Trials to conduct the study and implemented oversight controls including patient eligibility reviews and Data Safety Monitoring Board reviews during peak recruitment periods.
In other recent news, BioXcel Therapeutics has filed a prospectus supplement with the Securities and Exchange Commission for an $80 million at-the-market equity offering program. The company has entered into an Equity Distribution Agreement with Canaccord Genuity LLC, designating them as the sales agent for this program. Additionally, H.C. Wainwright has raised its price target for BioXcel Therapeutics from $8 to $10, maintaining a Buy rating in anticipation of upcoming clinical trial data. BioXcel recently completed its pivotal Phase 3 SERENITY At-Home clinical trial, with top-line data expected soon.
Moreover, BioXcel Therapeutics received positive feedback from the U.S. Food and Drug Administration regarding the potential expansion of its drug BXCL501 for at-home use in treating agitation associated with bipolar disorders or schizophrenia. The company believes this feedback supports its planned supplemental New Drug Application, which is on track for submission in the first quarter of 2026. The FDA’s written responses have also served as the official record for BioXcel’s pre-sNDA meeting for IGALMI’s at-home use. BioXcel is currently reviewing preliminary comments from the FDA ahead of a planned pre-sNDA meeting, aiming to align on the necessary format and content for its submission.
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