According to the lawsuit, 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 or prospects. Specifically, defendants failed to disclose to investors:
- BioXcel Therapeutics lacked adequate internal controls over protocol adherence and data integrity;
- as a result, BioXcel Therapeutics’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board (“IRB”);
- BioXcel Therapeutics’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”);
- BioXcel Therapeutics’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA;
- the foregoing would negatively impact BioXcel Therapeutics’s ability to obtain regulatory approval of BXCL501 (which is purportedly a proprietary, orally dissolving, film formulation of dexmedetomidine, or “Dex”) for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and
- as a result of the foregoing, defendants’ positive statements about BioXcel Therapeutics’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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