Twersky Law Group, a highly regarded and reputable law firm based in New York, wishes to inform investors about a significant development in the form of a class action lawsuit against BioXcel Therapeutics, Inc. (“BioXcel” or “the Company) (NASDAQ: BTAI) and certain officers of the company. This lawsuit has been filed on behalf of all individuals and entities that held, purchased, or otherwise acquired BioXcel securities from December 15, 2021 through July 28, 2023 (the “Class Period”). Investors who acquired BioXcel securities during this defined timeframe are strongly encouraged to participate in this case by contacting atara@twerskylawgroup.com. The deadline to file a motion for appointment of lead plaintiff is September 5, 2023.
The fundamental objective of this class action lawsuit is to recover for the benefit of investors who purchased BioXcel securities during the Class Period, the losses they sustained as a consequence of the misleading statements made by Defendants in violation of the federal securities laws.
ALLEGATIONS AGAINST BIOXCEL THERAPEUTICS, INC.
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 (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 investigators 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. The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company lacked adequate internal controls over protocol adherence and data integrity; (2) that, as a result, the Company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) that the Company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) that the Company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (5) that the foregoing would negatively impact the Company’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and (6) that, as a result of the foregoing, Defendants positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
ABOUT BIOXCEL THERAPEUTICS, INC.
What is BioXcel Therapeutics?
- BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.
Who is the CEO of BioXcel Therapeutics?
- Vimal Mehta is the Co-Founder, Chief Executive Officer, and a member of the Board of Directors of BioXcel Therapeutics, Inc.
JOIN THIS CASE
It is important to note that a class action lawsuit has already been filed in connection with these allegations. Therefore, for those who suffered financial losses in their investments in BioXcel during the Class Period, there is a limited opportunity to seek appointment as a lead plaintiff. This process entails requesting the Court to designate them as the primary representative on behalf of the entire Class. The deadline for submitting such a request is September 5, 2023. It is important to emphasize that while becoming a lead plaintiff can offer certain advantages, participation in the recovery process and the potential for financial compensation does not mandate serving as a lead plaintiff.
Twersky Law Group, a distinguished legal firm renowned for its attorneys expertise in handling securities fraud class actions and shareholder derivative suits, who have a long-standing track record of successfully recovering significant sums of money for investors nationwide. With an unwavering commitment to seeking justice for their clients, the firm’s attorneys are resolute in pursuing fair compensation on behalf of those affected by alleged securities law violations. As with any legal matter, it is essential to understand that this announcement constitutes attorney advertising. Past case outcomes and results achieved do not guarantee similar outcomes in this particular case.
Investors who believe they may qualify as potential Class members in the class action lawsuit against BioXcel are strongly encouraged to reach out directly to the firm for further information and assistance. The knowledgeable legal professionals at Twersky Law Group stand ready to provide guidance and support to investors seeking to protect their rights and pursue the recovery they deserve.
ABOUT US
For more information as well as to join this case please contact Atara Twersky, Esq. at atara@twerskylawgroup.com. Atara is Principal at Twersky Law Group and of counsel at AF&T Law Firm where she is director of Investor Services. Atara focuses her practice on assisting her clients with increasing their investment portfolio recoveries and ensuring that their portfolios remain healthy and robust. For more information on shareholder recoveries, listen to Atara ’s Pension and Investments Podcast with notable guests in the pension fund Industry that discusses various matters relating to investment portfolios. For more information on Atara and her legal work pertaining to shareholder protection click here.
