Full Press Release Details
NEW YORK, July 18, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP reminds investors that a complaint has been filed on behalf of persons and entities that purchased or acquired securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) securities between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”). Click Here to Join Investigation.
If you acquired BioXcel securities during the Class Period and would like to discuss this case, please click here. You may also contact us by emailing jcampisi@kaplanfox.com or calling (212) 329-8571.
If you are a member of the proposed Class, you may move the court no later than September 5, 2023 to serve as a lead plaintiff for the purported class. If you have losses, we encourage you to contact us to learn more about the lead plaintiff process.
According to the complaint, BioXcel is a biopharmaceutical company that claims it uses artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology, and on December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease. The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III.
As further alleged, on June 29, 2023, before the market opened, BioXcel disclosed that its principal investigator for the Phase 3 TRANQUILITY II clinical trial had failed to “adhere to the informed consent form approved by the Institutional Review Board” for some subjects and failed to maintain adequate case histories for certain patients whose records were reviewed by the Food and Drug Administration (“FDA”). The Company further disclosed that the same principal investigator “may have fabricated” email correspondence purporting to demonstrate that the investigator timely submitted to the Company’s pharmacovigilance safety vendor a report of a serious adverse event (“SAE”) and purporting to show that the vendor had confirmed receipt. BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022. The Company further disclosed that it was in the process of conducting an investigation into protocol adherence and data integrity at the principal investigator’s trial site and was in the process of retaining an independent third party to audit the data collected at the site. The Company also disclosed that the foregoing “may impact the timing of the Company’s development plans for, and prospects for regulatory approval of, BXCL501 for the acute treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.”
On this news, BioXcel’s stock price fell $11.28 per share, or 63.8%, to close at $6.39 per share on June 29, 2023, on unusually heavy trading volume.
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Tags
artificial intelligence
Bioxcel Therapeutics