Recent Updates
Recently added Catalysts
BTAI Negative Sentiment Score: 25/100

BioXcel Therapeutics, Inc. Investors: Contact Robbins LLP if You Incurred Significant Losses in BTAI

Key Takeaway: BioXcel Therapeutics, Inc. (BTAI) is facing a class action lawsuit filed by shareholders who allege that the company failed to disclose critical issues related to data integrity and protocol adherence during clinical trials for its drug BXCL501. These lapses included inadequate internal controls and fabricated communications to the FDA, leading to a significant drop in the company's stock price. Shareholders may file as lead plaintiffs by September 5, 2023, as the company grapples with its potential inability to secure regulatory approval for the treatment intended for agitation associated with dementia.

Market Sentiment Analysis

CONCERNS & RISKS

  • The company's failure to maintain adequate internal controls over protocol adherence and data integrity.
  • The principal investigator's alleged fabrication of email correspondence provided to the FDA.
  • Stock price fell over 63% following the revelation of the company's actions, indicating significant investor losses.
  • Potential inability to obtain regulatory approval for BXCL501 due to integrity issues in clinical trials.

Full Press Release Details

NEW YORK, July 26, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that 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.
For more information, submit a form, email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
What is this Case About: BioXcel Therapeutics, Inc. (BTAI) Clinical Trial Failed to Adhere to Data Integrity Controls
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. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Robbins LLP: Some law firms issuing releases about this matter do not actually litigate securities class actions; Robbins LLP does. A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. Since our inception, we have obtained over $1 billion for shareholders.
Attorney Advertising. Past results do not guarantee a similar outcome.

Tags

#BioXcel Therapeutics

Frequently Asked Questions

What led to the class action against BioXcel Therapeutics?

The class action arose from BioXcel's failure to maintain data integrity and protocol adherence.

What is BXCL501 used to treat?

BXCL501 is designed to treat agitation associated with psychiatric and neurological disorders.

When must lead plaintiff motions be filed?

Motions for lead plaintiff must be filed by September 5, 2023.

How did the stock price of BioXcel react to the news?

The stock price fell over 63%, from $17.67 to $6.39 per share on June 29, 2023.

Is representation in the class action contingent on fees?

No, all representation is on a contingency fee basis, incurring no costs for shareholders.

Last updated: Jul 26, 2023