SAN FRANCISCO, July 10, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges BioXcel Therapeutics, Inc. (NASDAQ: BTAI) investors who suffered substantial losses to submit your losses now.

Class Period: Dec. 15, 2021 – June 28, 2023
Lead Plaintiff Deadline: September 5, 2023
Visit: www.hbsslaw.com/investor-fraud/BTAI
Contact An Attorney Now: BTAI@hbsslaw.com
                                                     844-916-0895

BioXcel Therapeutics, Inc. (BTAI) Securities Fraud Class Action:

The litigation focuses on BioXcel’s statements and omissions regarding its TRANQUILITY II study evaluating its Alzheimer candidate drug BXCL501.

The complaint alleges Defendants failed to disclose to investors that: (1) BioXcel lacked adequate internal controls over protocol adherence and data integrity; (2) its principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) the principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) the principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was provided to the FDA; and (5) the foregoing would negatively impact the company’s ability to obtain regulatory approval of BXCL501.

Investors learned the truth on June 29, 2023, when BioXcel revealed that in Dec. 2022 the FDA inspected a clinical trial site in the TRANQUILITY II study and found that the principal investigator contravened the informed consent form by not timely informing the safety vendor of a serious adverse event (“SAE”) for one of the patients.

The company further revealed that the principal investigator also fabricated email correspondence in May 2023 to make it appear that she was following the clinical trial protocol, that it is investigating data integrity at the trial site, and that these developments could adversely impact the prospects for regulatory approval of BXCL501.

This news sent the price of BioXcel shares crashing lower that day.

“We’re focused on investors’ losses and proving BioXcel misled investors about its adherence to the trial protocol and the true commercial prospects for BXCL501,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

If you invested in BioXcel and have substantial losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman.

Whistleblowers: Persons with non-public information regarding BioXcel Therapeutics should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email BTAI@hbsslaw.com.

About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. 

Contact:
Reed Kathrein, 844-916-0895

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.