NEW YORK, Jan. 21, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) in the United States District Court for the District of Nevada on behalf of all persons and entities who purchased or otherwise acquired BioVie securities between August 5, 2021 and November 29, 2023, both dates inclusive (the “Class Period”). Investors have until March 19, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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On November 29, 2023, BioVie, Inc. issued a press release accompanying an investor presentation disclosing top line data from its clinical trial of NE3107 for the treatment of mild to moderate Alzheimer’s Disease. The press release stated that the trial started during the COVID-19 pandemic when access to clinical sites was limited and enrolled a total of 439 patients through 39 sites. Upon trial completion, the Company found significant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites. This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer them to the U.S. Food and Drug Administration (FDA) Office of Scientific Investigations (OSI) for further action.
On a conference call that same day, Defendants announced that the Phase 3 clinical trial did not achieve statistical significance due to the number of patients being excluded from the trial that the Company believed engaged in improper practices.
On November 29, 2023, the Company’s share price fell $3.03 per share, or more than 60%, to close at $1.96 per share, on unusually high trading volume.
The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements and failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, it is alleged that Defendants misled investors by failing to disclose that (1) BioVie was not conducting proper oversight of its Phase 3 clinical trial; (2) that the COVID-19 pandemic significantly and negatively impacted the Company’s ability to adequately conduct proper oversight of the Phase 3 clinical trial; (3) that due to lack of proper oversight and reliance on contract research organizations, the data from Defendants’ Phase 3 clinical trial faced a greater risk of being unreliable and that the majority of patients would have to be excluded from the clinical trial; (4) that, as a result of the significant exclusions from the trial results, the Phase 3 clinical trial would fail to meet its primary endpoints; and (5) statements about BioVie’s business, operations, prospects, and compliance with current good clinical practices (“cGCP”) were materially false and/or misleading and/or lacked a reasonable basis at all relevant times.
If you purchased or otherwise acquired BioVie shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
