NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of Nevada on behalf of all persons or entities who purchased or otherwise acquired BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities between August 5, 2021 and November 29, 2023, inclusive (the “Class Period”).
The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (i) the ongoing COVID-19 pandemic caused “limited access” to clinical trial sites, significantly affecting BioVie’s ability to conduct proper oversight of the clinical trial; (ii) due to the “limited access” to the clinical trial sites, the trial was at higher risk of having “significant deviation from protocol and Good Clinical Practice (GCP) violations” and “anomalous data”; (iii) BioVie was experiencing issues with the contract research organizations it had retained, creating greater risk of the trial being in non-compliance with GCPs; (iv) BioVie had identified “higher than expected levels of deviations” in the data; (v) due to a “highly unusual level of suspected improprieties” there was a heightened risk a majority of the clinical trial subjects would be excluded; and (vi) as a result of the exclusions, there was a heightened material risk that the clinical trial would “not achieve statistical significance.”
The Complaint further alleges that on November 8, 2023, BioVie disclosed that it “uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites” and that “these findings of potential scientific misconduct and significant GCP violations may call into question the rigor, robustness and validity of the entire data set for this study (NCT04669028) and may require additional clinical studies to confirm the final results of the study.” On this news, the price of BioVie stock fell more than 29%, according to the complaint.
The Complaint also alleges that on November 29, 2023, BioVie revealed that it “found significant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites.” BioVie’s CEO, defendant Cuong Do, further revealed that the trial “did not achieve statistical significance because we had to exclude so many patients from the trials that we believe engaged in improper practices,” the complaint further alleges. On this news, the price of BioVie stock fell nearly 61%, according to the complaint.
Investors who purchased or otherwise acquired shares of BioVie should contact the Firm prior to the March 19, 2024 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
