BioVie Inc. Cass Action Lawsuit - BIVI

26 days left to seek lead plaintiff status

Case Summary

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The BioVie class action lawsuit seeks to represent purchasers or acquirers of BioVie Inc. (NASDAQ: BIVI) publicly traded securities between August 5, 2021 and November 29, 2023, inclusive (the “Class Period”).  Captioned Olmstead v. BioVie Inc., No. 24-cv-00035 (D. Nev.), the BioVie class action lawsuit charges BioVie and certain of BioVie’s top executives with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the BioVie class action lawsuit, please provide your information in the form on this page.  You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com.  Lead plaintiff motions for the BioVie class action lawsuit must be filed with the court no later than March 19, 2024.

CASE ALLEGATIONS: BioVie is a clinical stage biopharmaceutical company that purports to engage in the discovery, development, and commercialization of innovative drugs therapies.  The complaint alleges that on August 5, 2021, BioVie announced the enrollment of the first patient in its Phase 3 study of NE3107 in Alzheimer’s Disease.

The BioVie class action lawsuit alleges that defendants throughout the Class Period 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 BioVie class action lawsuit 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.

Then, as the complaint further alleges, 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.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired BioVie publicly traded securities during the Class Period to seek appointment as lead plaintiff in the BioVie class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the BioVie class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the BioVie class action lawsuit.  An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the BioVie class action lawsuit.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: Robbins Geller Rudman & Dowd LLP is one of the world’s leading complex class action firms representing plaintiffs in securities fraud cases.  The Firm is ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report for recovering more than $1.75 billion for investors in 2022 – the third year in a row Robbins Geller tops the list.  And in those three years alone, Robbins Geller recovered nearly $5.3 billion for investors, more than double the amount recovered by any other plaintiffs’ firm.  With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.

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