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BIOXCEL THERAPEUTICS, INC. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against BioXcel Therapeutics, Inc. (NASDAQ: BTAI)

Key Takeaway: Bernstein Liebhard LLP has announced a securities class action lawsuit against BioXcel Therapeutics, Inc. for allegedly making materially false and misleading statements throughout a specified class period. The lawsuit claims deficiencies in the company's internal controls and mismanagement regarding clinical trial protocols, which have adversely affected its product BXCL501. The stock price dropped significantly by 63.8% following disclosures of these issues, raising concerns about future regulatory approvals. Investors are encouraged to discuss their legal rights and options regarding their investments in the company.
Price reaction · baseline $162.24 (2023-07-10 close) · hit after-hours · 3 other BTAI headline(s) in the window, move may be shared
day 0 close · peak
+4.1%

Market Sentiment Analysis

CONCERNS & RISKS

  • BioXcel is facing a securities class action lawsuit with allegations of materially false statements.
  • The company's principal investigator failed to follow approved protocols, impacting data integrity.
  • The stock plummeted by 63.8% following the news of compliance issues, indicating severe market reaction.
  • Concerns raised over the company's ability to gain regulatory approval for its lead product due to these violations.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+91%
120-day peak, hindsight
Typical move
4.7%
average across 7 past catalysts
Cash runway
~6 mo
High dilution risk
Lead asset
BXCL701
Phase 2 · Metastatic Pancreatic Ductal Adenocarcinoma

Full Press Release Details

NEW YORK, July 11, 2023 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP:
Do you, or did you, own shares of BioXcel Therapeutics, Inc. (NASDAQ: BTAI)?
Did you purchase your shares between December 15, 2021 and June 28, 2023, inclusive?
Did you lose money in your investment in BioXcel Therapeutics, Inc.?
Do you want to discuss your rights?
Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the District of Connecticut and alleges violations of the Securities Exchange Act of 1934 against the Company and certain of its officers (the “Complaint”).
If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com.
According to the Complaint, BioXcel 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.
Plaintiff alleges that Defendants made materially false and misleading statements throughout the Class Period. Among other things, Defendants failed to disclose to investors 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; and (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.
On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
However, on June 29, 2023, before the market opened, BioXcel disclosed, among other things, that its principal investigator for a Phase 3 clinical trial had failed to “adhere to the informed consent form approved by the Institutional Review Board” for some subjects and failed to maintain adequate case histories for certain patients whose records were reviewed by the Food and Drug Administration.
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.
If you wish to serve as lead plaintiff, you must move the Court no later than September 5, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
ATTORNEY ADVERTISING. © 2023 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Bernstein Liebhard LLP

Frequently Asked Questions

What is the class action lawsuit about BioXcel Therapeutics?

The lawsuit involves allegations of misleading statements made by BioXcel regarding its internal controls and clinical trial data.

When was the BioXcel class action period?

The class action period for BioXcel spans from December 15, 2021, to June 28, 2023.

How much did BioXcel's stock drop on June 29, 2023?

BioXcel's stock fell by $11.28, or 63.8%, closing at $6.39 per share.

What must potential lead plaintiffs do?

Interested lead plaintiffs must file a motion with the Court by September 5, 2023.

Who should be contacted for more information about the lawsuit?

Contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com for details.

Last updated: Jul 11, 2023