The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed in the United States District Court for the District of Connecticut against BioXcel Therapeutics, Inc. (“BioXcel”) (NASDAQ: BTAI). The action charges BioXcel with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company’s business, operations, and prospects. As a result of BioXcel’s materially misleading statements and omissions to the public, BioXcel’s investors have suffered significant losses.

CLICK HERE TO SUBMIT YOUR BIOXCEL LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/bioxcel-therapeutics-inc?utm_source=PR&utm_medium=link&utm_campaign=btai&mktm=r

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LEAD PLAINTIFF DEADLINE: SEPTEMBER 5, 2023

CLASS PERIOD: DECEMBER 15, 2021 THROUGH JUNE 28, 2023

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:

Jonathan Naji, Esq. at (484) 270-1453 or via email at info@ktmc.com

Kessler Topaz is one of the world’s foremost advocates in protecting the public against corporate fraud and other wrongdoing. 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. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

BIOXCEL’S ALLEGED MISCONDUCT

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.

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. 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.

Further, 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.”

Following 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.

WHAT CAN I DO?

BioXcel investors may, no later than September 5, 2023, move the Court to serve as lead plaintiff for the class, through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages BioXcel investors who have suffered significant losses to contact the firm directly to acquire more information. The class action complaint against BioXcel, captioned Katelyn Martin v. BioXcel Therapeutics, et al. and docketed under 23-cv-00915, is filed in the United States District Court for the District of Connecticut before the Honorable Sarala Vidya Nagala.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

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