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."įollowing 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.īioXcel investors may, no later than September 5, 2023, move the Court to serve as lead plaintiff for the class, through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. BioXcel also disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.įurther, 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. 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. 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 FDA. 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. BioXcel stated that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III. 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. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. at (484) 270-1453 or via email at Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. LEAD PLAINTIFF DEADLINE:SEPTEMBER 5, 2023ĬONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS: CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE
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