Full Press Release Details
BOSTON, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Block & Leviton LLP (www.blockleviton.com), a national securities litigation firm, announces that it has filed a class action lawsuit on behalf of shareholders against BioVie, Inc. (NASDAQ: BIVI) and certain of its executives, for securities fraud. The complaint was brought in United States District Court for the District of Nevada and is captioned Olmstead v. BioVie, Inc., et al., No. 3:24-cv-00035 (D. Nev.) and is brought on behalf of investors that incurred damages on their purchases in BioVie, Inc. securities between August 5, 2021 and November 29, 2023, inclusive.
A class has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
Investors who purchased BioVie, Inc. shares between August 5, 2021 and November 29, 2023 and who lost money are strongly encouraged to contact Block & Leviton attorneys at (617) 398-5600, via email at cases@blockleviton.com, or to visit our website for information on the case.
The deadline to seek appointment as lead plaintiff is March 19, 2024.
What is this all about?
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 acquired BioVie, Inc. shares between August 5, 2021 and November 29, 2023 and have questions about your legal rights or possess information relevant to this matter, please contact Block & Leviton attorneys at (617) 398-5600, via email at cases@blockleviton.com, or visit our website. The deadline to seek appointment as lead plaintiff is March 19, 2024.
Block & Leviton is widely regarded as one of the leading securities class action firms in the country. Our attorneys have recovered billions of dollars for defrauded investors and are dedicated to obtaining significant recoveries on behalf of our clients through active litigation in the federal courts across the country. Many of the nation's top institutional investors hire us to represent their interests. You can learn more about us at our website, www.blockleviton.com, or call (617) 398-5600 or email cases@blockleviton.com with any questions.
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SOURCE: Block & Leviton LLP
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Good Clinical Practice