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BIVI Negative Sentiment Score: 15/100

BIOVIE SHAREHOLDER NOTICE: Faruqi & Faruqi Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $25,000 In BioVie To Contact Him Directly To Discuss Their Options

Key Takeaway: Faruqi & Faruqi, LLP is investigating potential claims against BioVie Inc. due to allegations of federal securities law violations. These include claims that BioVie failed to properly oversee its Phase 3 clinical trial for NE3107, which was impacted by the COVID-19 pandemic. As a result of significant deviations from clinical protocol, the trial did not achieve statistical significance and led to a major drop in the company's share price. A class action lawsuit has been filed, and investors affected by losses exceeding $25,000 are encouraged to take action before the March 19, 2024 deadline.

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CONCERNS & RISKS

  • BioVie faces potential securities class action due to alleged mismanagement.
  • The Phase 3 clinical trial outcome was disappointing, failing to meet primary endpoints.
  • The company's stock price plummeted over 60% following negative trial results.
  • Claims include lack of oversight during clinical trials and significant protocol violations.

Full Press Release Details

If you suffered losses exceeding $25,000 investing in BioVie stock or options between August 5, 2021 and November 29, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/BIVI.
There is no cost or obligation to you.
NEW YORK, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) and reminds investors of the March 19, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose: (1) that 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.
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 court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding BioVie’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.
James (Josh) Wilson Faruqi & Faruqi, LLP
James (Josh) Wilson Faruqi & Faruqi, LLP

Frequently Asked Questions

What is the deadline to seek lead plaintiff status for BioVie?

The deadline to seek lead plaintiff status in the BioVie case is March 19, 2024.

How much must I have lost to discuss legal rights regarding BioVie?

You must have suffered losses exceeding $25,000 in BioVie stock or options.

Who should I contact about potential claims against BioVie?

You can call Faruqi & Faruqi partner Josh Wilson at 877-247-4292 for assistance.

Is there a cost to discuss my case with Faruqi & Faruqi?

There is no cost or obligation to discuss your legal rights with the firm.

What were the main issues with BioVie’s clinical trial?

The trial faced oversight issues, improper practices, and significant protocol deviations.

Last updated: Feb 23, 2024