Archived Investigations

BioXcel Therapeutics, Inc. (NasdaqCM: BTAI)

Company Name:BioXcel Therapeutics, Inc.
Stock Symbol:NasdaqCM: BTAI
Court:District of Connecticut
Class Period Start:12/15/2021
Class Period End (inclusive):06/28/2023
Filing Deadline:The deadline has passed.
July 10, 2023

BioXcel and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws. 

On June 29, 2023, pre-market, the Company disclosed that in December 2022, the U.S. Food and Drug Administration (“FDA”) identified three “inspectional observations“ from the Company’s clinical trial for its BXCL501 drug product relating to “the principal investigator’s failure to adhere to the informed consent form approved by the Institutional Review Board for a limited number of subjects whose records the FDA reviewed, maintain adequate case histories for certain patients whose records the FDA reviewed, and adhere to the investigational plan in certain instances.”  Further, the Company disclosed that in May 2023, it learned that the same investigator “may have fabricated email correspondence” to show that a serious adverse event report had been timely submitted to   the Company’s pharmacovigilance safety vendor and that it was investigating “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, shares of BioXcel fell $11.28 per share, or 63.8%, to close at $6.39 per share on June 29, 2023, on unusually heavy trading volume.

The case is Martin v. BioXcel Therapeutics, Inc., et al., No. 23-cv-00915.

Click here to read the first filed complaint.