Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) securities between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”) have until September 5, 2023 to seek appointment as lead plaintiff of the BioXcel class action lawsuit. Captioned Martin v. BioXcel Therapeutics, Inc., No. 23-cv-00915 (D. Conn.), the BioXcel class action lawsuit charges BioXcel and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the BioXcel class action lawsuit, please provide your information here:

https://www.rgrdlaw.com/cases-bioxcel-therapeutics-inc-class-action-lawsuit-btai.html

You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com.

CASE ALLEGATIONS: BioXcel is a biopharmaceutical company that claims to use artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. On December 15, 2021, BioXcel announced that it had initiated a program to evaluate its developmental drug, BXCL501, for the treatment of acute agitation associated with Alzheimer’s disease.

The BioXcel class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) BioXcel lacked adequate internal controls over protocol adherence and data integrity; (ii) as a result, BioXcel’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (iii) BioXcel’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the U.S. Food and Drug Administration (“FDA”); (iv) BioXcel’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; and (v) the above would negatively impact BioXcel’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.

On June 29, 2023, BioXcel disclosed that its principal investigator for the Phase 3 BXCL501 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. BioXcel further disclosed that the same principal investigator “may have fabricated” email correspondence purporting to demonstrate that the investigator timely submitted to BioXcel’s pharmacovigilance safety vendor a report of serious adverse events 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 and that BioXcel was in the process of conducting an investigation into the protocol adherence and data integrity at the principal investigator’s trial site and was in the process of retaining an independent third party to audit the data collected at the site. Finally, BioXcel also disclosed that the above “may impact the timing of [BioXcel’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, the price of BioXcel stock fell nearly 64%, damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired BioXcel securities during the Class Period to seek appointment as lead plaintiff of the BioXcel class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the BioXcel class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the BioXcel class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the BioXcel class action lawsuit.

ABOUT ROBBINS GELLER: Robbins Geller is one of the world’s leading complex class action firms representing plaintiffs in securities fraud cases. The Firm is ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report for recovering more than $1.75 billion for investors in 2022 – the third year in a row Robbins Geller tops the list. And in those three years alone, Robbins Geller recovered nearly $5.3 billion for investors, more than double the amount recovered by any other plaintiffs’ firm. With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:

https://www.rgrdlaw.com/services-litigation-securities-fraud.html

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