Case Summary

BioVie

NASDAQ: BIVI

Case Details

  • Olmstead v. BioVie Inc. et al.
  • Class Period:August 05, 2021 - November 29, 2023
  • Date Filed:January 19, 2024
  • Jurisdiction:U.S. District Court, District of Nevada
  • Docket Number: 3:24-cv-00035
  • Lead Plaintiff Deadline: March 19, 2024
Days Left to
Seek Plaintiff
27

Overview

A class action lawsuit has been filed against BioVie, Inc., (“BioVie” or the “Company”) (NASDAQ: BIVI) and certain of the Company’s current and former senior executive officers alleging violations of the Securities Exchange Act of 1934. The lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired publicly traded BioVie securities from August 05, 2021, through November 29, 2023, both dates inclusive (the “Class Period”) and investors have until March 19, 2024, to seek appointment as lead plaintiff of the BioVie class action lawsuit.

BioVie is a clinical stage biopharmaceutical company that purports to engage in the discovery, development, and commercialization of innovative drugs therapies, including for treatment of neurological and neurodegenerative disorders and advanced liver disease.

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 lawsuit alleges that Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the lawsuit alleges 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.

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If you purchased or otherwise acquired publicly traded BioVie (NASDAQ: BIVI) securities from August 05, 2021, through November 29, 2023, both dates inclusive, and suffered substantial losses, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the BioVie lawsuit is March 19, 2024.

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