BioXcel Therapeutics, Inc. is a biopharmaceutical company that claims it uses artificial intelligence (“AI”) approaches to develop medicines in neuroscience and immuno-oncology. The Company states that it leverages existing approved drugs and clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. BioXcel claims that its most advanced clinical development program is BXCL501, which is purportedly a proprietary, orally dissolving, film formulation of dexmedetomidine (or “Dex”) for the treatment of agitation associated with psychiatric and neurological disorders.

A recently filed securities fraud class action complaint alleges that BioXcel Therapeutics Inc. (NASDAQ: BTAI), via certain officers and directors, 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, the complaint alleges 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.

Current BioXcel shareholders who have held BioXcel stock since prior to December 15, 2021, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award at no cost to them whatsoever.

If you would like to learn more about this matter, you are encouraged to contact us at jgrabar@grabarlaw.com, or call 267-507-6085.