Shares of BioXcel Therapeutics Inc. (BTAI) skyrocketed over 40% in premarket trading on Wednesday following the announcement that an independent audit of their Alzheimer's trial data revealed no issues affecting the integrity and reliability of the data.
The audit specifically focused on data obtained from a single site involved in BioXcel's late-stage trial for an experimental treatment targeting Alzheimer's-related agitation in individuals aged 65 and older. Based on the findings of the audit, BioXcel expressed confidence that the phase 3 trial data released in June could support a regulatory application for the approval of their treatment, BXCL501.
Concerns regarding the trial data initially emerged in late June when a regulatory filing by BioXcel stated that they had discovered a principal investigator associated with the trial who may have falsified emails purportedly demonstrating the timely submission of certain safety data. In response, the company promptly launched an investigation and engaged an independent third party to assess the data from the investigator's trial site.
Furthermore, on Wednesday, BioXcel disclosed that no additional instances of misconduct or fraud were found by the audit team.
In recent developments, BioXcel held a meeting with the U.S. Food and Drug Administration (FDA) to discuss their plans for the development of BXCL501. The company anticipates receiving the FDA meeting minutes in the first half of November.
Despite experiencing an 89% dip in share value year-to-date, BioXcel remains optimistic about the future, especially with the positive outcome of the independent audit. In comparison, the S&P 500 index has seen a 10.6% increase.
This news reaffirms BioXcel's commitment to advancing medical research for Alzheimer's and their dedication to ensuring the reliability of trial data. The discovery of no critical issues in the audit bolsters the company's chances of success when seeking regulatory approval for their promising treatment.