BioXcel Therapeutics shares pop after audit of Alzheimer's trial data

By Eleanor Laise

Audit findings support application for approval of treatment for Alzheimer's-related agitation, company says

Shares of BioXcel Therapeutics Inc. (BTAI) 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.

The audit team did not find evidence of any additional misconduct or fraud, BioXcel said Wednesday.

BioXcel recently had a meeting with the U.S. Food and Drug Administration to discuss plans for development of BXCL501 and expects to receive the FDA meeting minutes in the first half of November, the company said in a release.

BioXcel shares have dropped 89% in the year to date, while the S&P 500 SPX is up 10.6%.

-Eleanor Laise

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10-25-23 0844ET

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