Following a significant regulatory update, BioXcel Therapeutics, Inc. (NASDAQ: BTAI) stock saw a sharp increase in value. As of the recent market check, BTAI stock price rose by 96.14%, reaching $4.20. This significant rise is a reaction to recent events involving the FDA’s (U.S. Food and Drug Administration) assessment of its clinical trial location.
Reaching a Regulatory Milestone
The FDA has finished inspecting one site in the TRANQUILITY II Phase 3 study, according to BioXcel. The inspection status was closed and an Establishment Inspection Report was issued by the agency in accordance with 21 C.F.R. 20.64(d)(3). Although minor concerns may have been found, the site was classified as “Voluntary Action Indicated,” which means that regulatory action is not necessary.
The completion of this inspection, together with the positive results of an independent audit carried out in October 2023, further confirms the accuracy of the trial data, BTAI stressed.
These results will be included in a prospective supplementary new drug application (sNDA) filing for regulatory evaluation, according to BioXcel. Furthermore, BTAI is proceeding with its primary neuroscience candidate, BXCL501, after receiving FDA comments on the plan for its TRANQUILITY In-Care Phase 3 study.
Promoting Clinical Development
BXCL501 is a patented sublingual film formulation of the selective alpha-2 adrenergic receptor agonist dexmedetomidine that has received FDA approval. It is sold under the brand name IGALMI. The experimental formulation is now being studied for the treatment of acute agitation associated with schizophrenia, bipolar disorder, and Alzheimer’s dementia in home-based settings, despite having previously been licensed for certain uses.
The TRANQUILITY In-Care Trial
The 12-week, double-blind, placebo-controlled TRANQUILITY In-Care study aims to assess the safety and efficacy of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s disease in a care facility setting. BioXcel Therapeutics expects more regulatory contacts as its clinical projects advance, which might affect how its drug development activities develop in the future.