Audit findings support application for approval of treatment for Alzheimer’s-related agitation, company says
Shares of BioXcel Therapeutics Inc. BTAI, +0.86% jumped more than 40% premarket on Wednesday after the company said an independent audit of Alzheimer’s trial data found no issues impacting the data’s integrity and reliability.
The audit reviewed data from a single site of BioXcel’s late-stage trial of an experimental treatment for Alzheimer’s-related agitation in people 65 and older. Based on the audit findings, BioXcel said it believes that the phase 3 trial data it released in June may support a regulatory application for approval of the treatment, BXCL501.
Questions about the trial data arose in late June, when BioXcel said in a regulatory filing that it had learned that a principal investigator involved in the trial may have fabricated emails purporting to show that the investigator had submitted certain safety data in a timely fashion. The company said it promptly initiated an investigation and retained an independent third party to audit the data from the investigator’s trial site.BioXcel recently had a meeting with the U.S.
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