NEW YORK, Dec. 1, 2023 /PRNewswire/ — Moore Kuehn, PLLC, a securities and shareholder law firm located on Wall Street, is investigating potential claims against:
* BioXcel Therapeutics, Inc. (“BioXcel”) (NASDAQ: BTAI)
On December 15, 2021, BioXcel announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease. BioXcel stated that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III. The studies were purportedly designed to evaluate the safety and efficacy of BXCL501 in adults 65 years and older across the range of illness including mild, moderate, and severe dementia in assisted living or residential facilities and nursing homes.
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 FDA. Additionally, BioXcel 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 purporting to show that the vendor had confirmed receipt. BioXcel also disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
BioXcel revealed that it was in the process of conducting an investigation into protocol adherence and data integrity at the principal investigator’s trial site and that it was in the process of retaining an independent third party to audit the data collected at the site. Finally, BioXcel 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.”
If you own BioXcel Therapeutics, Inc. (“BioXcel”) (NASDAQ: BTAI), please contact Fletcher Moore, Esq. by email at [email protected]. There is no cost to you. Moore Kuehn is a New York-based law firm with attorneys representing investors and consumers.
Please visit http://www.moorekuehn.com/practice/new-york-shareholder-derivative-litigation/
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