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BioWorld - Thursday, January 22, 2026
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Home » Bioxcel shares plunge on FDA warning letter despite promising data for Alzheimer’s acute agitation candidate
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Bioxcel shares plunge on FDA warning letter despite promising data for Alzheimer’s acute agitation candidate

June 29, 2023
By Marian (YoonJee) Chu and Karen Carey
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
BioWorld Clinical Regulatory Neurology/psychiatric

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