BioXcel Therapeutics, Inc. (BTAI) Securities Lawsuit Investigation
On June 29, 2023, BioXcel Therapeutics, Inc. disclosed potential fraud related to how its safety data was being recorded at a late-stage drug trial testing site, as reported by Investor’s Business Daily.
Following this news, BioXcel’s stock price dropped 65% on June 29, 2023, causing significant harm to investors.
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Why is BTAI stock dropping?
On Thursday, June 29, 2023, shares of biotech company BioXcel dropped 65% after the company disclosed that the principal investigator at its clinical trial site fabricated emails meant to demonstrate that a report detailing an adverse safety event in a patient had been timely reported. After BioXcel became aware of the fabricated emails in May 2023, it launched an investigation and then recently announced a plan to hire an independent auditing group to investigate the issue. According to BioXcel, this may delay “the timing of the Company’s development plans for, and prospects for regulatory approval” of its Alzheimer’s drug, BXCL501, by two to three months.
Previously, in December 2022, the FDA conducted an on-site inspection and discovered that the same principal investigator may have failed to follow certain protocols, including adhering to the study’s approved consent form and keeping adequate case histories for certain patients.
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