BioXcel Therapeutics, Inc. (BTAI) Clinical Trial Failed to Adhere to Data Integrity Controls

A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired BioXcel Therapeutics, Inc. (NASDAQ: BTAI) securities between December 15, 2021 and June 28, 2023. BioXcel is a biopharmaceutical company that claims it uses artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. BioXcel claims that its most advanced clinical development program is BXCL501, which is purportedly a proprietary, orally dissolving, film formulation of dexmedetomidine for the treatment of agitation associated with psychiatric and neurological disorders.

According to the complaint, during the class period, 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; and (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.

When the truth was revealed, the Company's stock price fell $11.28 per share, or over 63%, to close at $6.39 per share on June 29, 2023.

What Now: Similarly situated shareholders may be eligible to participate in the class action against BioXcel Therapeutics, Inc.  Shareholders who want to act as lead plaintiff for the class must file their motion with the court by September 5, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.