BioXcel Therapeutics Aligns With FDA Recommendation For Phase 3 Trial For TRANQUILITY Program To Support Potential sNDA For Acute Treatment Of Agitation Associated With Dementia Due To Probable Alzheimer's Disease
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BioXcel Therapeutics has agreed to follow FDA recommendations for a Phase 3 trial of its TRANQUILITY program, which aims to support a potential supplemental New Drug Application (sNDA) for the acute treatment of agitation in patients with dementia related to Alzheimer's disease.
November 14, 2023 | 12:06 pm
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BioXcel Therapeutics is proceeding with a Phase 3 trial for its TRANQUILITY program as recommended by the FDA, which could lead to a potential sNDA for treating agitation in Alzheimer's-related dementia.
The alignment with FDA recommendations for the Phase 3 trial is a positive development for BioXcel Therapeutics, indicating progress in the regulatory process. This step is crucial for the potential approval of the treatment, which could significantly impact the company's product pipeline and future revenues. The news is likely to be viewed positively by investors, potentially leading to a short-term increase in the stock price.
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