HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages BioXcel Therapeutics (BTAI) Investors with Substantial Losses to Contact Firm, Firm Investigating Possible Securities Law Violations
SAN FRANCISCO, June 29, 2023 (GLOBE NEWSWIRE) — Hagens Berman urges BioXcel Therapeutics, Inc. (NASDAQ: BTAI) investors who suffered substantial losses to submit your losses now.
Visit: www.hbsslaw.com/investor-fraud/BTAI
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BioXcel Therapeutics, Inc. (BTAI) Investigation:
The investigation focuses on BioXcel’s statements and omissions regarding its TRANQUILITY II study evaluating its Alzheimer candidate drug BXCL501.
Specifically, June 29, 2023, BioXcel revealed that in Dec. 2022 the FDA conducted an inspection of one of the clinical trial sites in the Phase 3 TRANQUILITY II clinical trial and issued a Form 483 finding that the principal investigator did not timely inform the safety vendor of a serious adverse event (“SAE”) for one of the patients.
Then, in May 2023, “this same principal investigator may have fabricated email correspondence purporting to demonstrate that the investigator timely submitted to the Company’s pharmacovigilance safety vendor a report of an SAE from a different subject than the one cited in the FDA Form 483, and purporting to show that the vendor had confirmed receipt.” The company further revealed that it confirmed that the principal investigator fabricated the correspondence to make it appear that she was following the clinical trial protocol and that it is investigating data integrity at the trial site.
Finally, on June 29, 2023, BioXcel said these developments could adversely impact the prospects for regulatory approval of BXCL501 for the acute treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.
This news sent the price of BioXcel shares crashing lower that day.
“We’re focused on investors’ losses and whether BioXcel may have misled investors about its adherence to the trial protocol and the true commercial prospects for its Alzheimer’s drug,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
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 [email protected].
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
