INVESTOR ALERT: Edelson Lechtzin LLP Urges BioXcel Therapeutics, Inc. (NASDAQ: BTAI) Shareholders with Substantial Losses to Seek Leadership in the Securities Fraud Class Action
NEWTOWN, PA, July 11, 2023 — The law firm of Edelson Lechtzin LLP is investigating securities fraud claims on behalf of all purchasers of BioXcel Therapeutics, Inc. (“BioXcel”) (NASDAQ: BTAI) common stock between December 15, 2021, and June 28, 2023 (the “Class Period”).
Investors who purchased BioXcel common stock may move the Court to appoint them as lead plaintiff, no later than September 5, 2023. Current holders of BioXcel stock may pursue corporate governance reforms. Please contact Edelson Lechtzin LLP at 844-696-7492 to discuss your investment losses, or by e-mail at [email protected]. A copy of the class action complaint can be viewed HERE.
Background on BioXcel Therapeutics, Inc.
BioXcel is a biopharmaceutical company headquartered in New Haven, Connecticut that employs advanced artificial intelligence techniques to develop cutting-edge medicines in the fields of neuroscience and immuno-oncology.
The Securities Fraud Claims
On December 15, 2021, BioXcel announced the launch of a program aimed at evaluating the efficacy of BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
The complaint alleges, that throughout the Class Period, Defendants made materially false and/or misleading statements regarding the BioXcel’s business, operations, and prospects and/or failed to disclose to investors that: (i) BioXcel lacked adequate internal controls over protocol adherence and data integrity; (ii) as a result, BioXcel’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (iii) BioXcel’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”); (iv) BioXcel’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (v) the foregoing would negatively impact BioXcel’s ability to obtain FDA approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.
BioXcel issued a statement prior to the opening of the market on June 29, 2023, disclosing that the principal investigator overseeing the Phase 3 TRANQUILITY II clinical trial had not adhered to the informed consent form approved by the Institutional Review Board and failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA. The Company also disclosed that the same principal investigator “may have fabricated” email correspondence provided to the FDA during an on-site inspection in December 2022 and that they are in the process of investigating the 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. On this news, BioXcel’s stock price fell $11.28 per share, or 63.8%, to close at $6.39 per share on June 29, 2023, on unusually heavy trading volume.
For more information, please contact:
Marc H. Edelson, Esq.
Eric Lechtzin, Esq.
EDELSON LECHTZIN LLP
411 S. State Street, Suite N-300
Newtown, PA 18940
Phone: 844-696-7492 or 215-867-2399 ext. 1
Email: [email protected]
Email: [email protected]
Edelson Lechtzin LLP is a national class action law firm with offices in Pennsylvania and California. In addition to cases involving securities and investment fraud, our lawyers focus on class and collective litigation in cases alleging violations of the federal antitrust laws, employee benefit plans under ERISA, wage theft and unpaid overtime, consumer fraud, and data breaches.
This press release may be considered Attorney Advertising in some jurisdictions. No class has been certified in this case, so 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. Your ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.