NEW YORK, Feb. 09, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against BioXcel Therapeutics, Inc. (NASDAQ:BTAI) on behalf of long-term stockholders following a class action complaint that was filed against BioXcel on July 7, 2023 with a Class Period from December 15, 2021 to June 28, 2023. Our investigation concerns whether the board of directors of BioXcel have breached their fiduciary duties to the company.
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. 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.
However, 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 ...