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BioXcel Therapeutics, Inc. (NASDAQ:BTAI) has reached a new milestone in its SERENITY At-Home pivotal Phase 3 trial by enrolling 100 patients, which is half of the expected total for the study. The trial, which began in September 2024, is evaluating the safety of BXCL501, the company’s investigational, orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation in patients with bipolar disorders or schizophrenia in a home setting. The company’s stock has shown resilience with a 10.8% return over the past week, despite facing significant market challenges.
As of March 20, 2025, 24 clinical trial sites have been established to facilitate the study. The topline data from this trial is anticipated in the second half of 2025. The findings are aimed at supporting a supplemental new drug application (sNDA) to potentially expand the label of IGALMI® (dexmedetomidine) sublingual film. According to InvestingPro analysis, the company faces financial challenges with significant cash burn and negative earnings of -$31.78 per share in the last twelve months.
BioXcel Therapeutics, headquartered in New Haven, CT, is focused on the development of pharmaceutical preparations, as indicated by its SIC code 2834. The company is incorporated in Delaware and operates under the IRS number 821386754.
The information reported here is based on a press release statement filed with the Securities and Exchange Commission.
In other recent news, BioXcel Therapeutics has reported significant financial and regulatory developments. The company successfully raised $14 million through an equity financing round, increasing its cash reserves to approximately $35 million. This capital is allocated to the ongoing Phase 3 SERENITY At-Home trial, which is investigating the safety of BXCL501 for at-home treatment of agitation in bipolar disorder or schizophrenia patients. The trial has reached 33% enrollment, with 23 clinical trial sites actively participating, and topline results are anticipated in the second half of 2025. Additionally, the U.S. Food and Drug Administration (FDA) has concluded an inspection of a site involved in the TRANQUILITY II Phase 3 trial, issuing a "Voluntary Action (WA:ACT) Indicated" status. Despite these advancements, BofA Securities has maintained its Underperform rating for BioXcel Therapeutics, highlighting concerns about the company’s financial expenditure rate. Furthermore, BioXcel has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. The company also announced the resignation of Vincent J. O’Neill, M.D., its Executive Vice President and Chief of Product Development and Medical (TASE:BLWV) Officer.
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