Case Background:
This is a federal securities fraud class action lawsuit on behalf of those who purchased or otherwise acquired BioXcel Therapeutics, Inc. (“BioXcel”) (NASDAQ: BTAI) common stock between March 9, 2023 and August 11, 2023, inclusive (the “Class Period”).
The complaint 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 that: (1) the company lacked adequate internal controls over protocol adherence and data integrity; (2) as a result, the company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) the company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) the company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (5) 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) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
Current Status of Case:
On October 29, 2025, Defendants filed an Answer to the Amended Complaint. This action is in the discovery phase and is ongoing.
If you wish to discuss this action or have any questions, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.