San Diego, CA -- (SBWIRE) -- 08/11/2023 -- An investor, who purchased shares of BioXcel Therapeutics, Inc. (NASDAQ: BTAI), filed a lawsuit over alleged violations of Federal Securities Laws by BioXcel Therapeutics, Inc.

Investors who purchased shares of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) have certain options and for certain investors are short and strict deadlines running. Deadline: September 5, 2023. NASDAQ: BTAI investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

New Haven, CT based BioXcel Therapeutics, Inc., a commercial-stage biopharmaceutical company, engages in utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.

On December 15, 2021, BioXcel Therapeutics, Inc. 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.

On June 29, 2023, before the market opened, BioXcel Therapeutics, Inc. 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 investigator's 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."

Shares of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) declined from $34.13 per share on February 09, 2023, to as low as $5.88 per share on June 29, 2023.

The plaintiff claims that between December 15, 2021 and June 28, 2023, the Defendants failed to disclose to investors that the Company lacked adequate internal controls over protocol adherence and data integrity, that, as a result, the Company's principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board, that the Company's principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA, that the Company's principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA, 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 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.

Those who purchased shares of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About The Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.