The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities between August 5, 2021 through November 29, 2023, inclusive (the “Class Period”). BioVie investors have until March 19, 2024 to file a lead plaintiff motion.

If you are a shareholder who suffered a loss, click here to participate.

On November 8, 2023, BioVie disclosed that, for the Phase 3 clinical trial of its Alzheimer’s treatment, NE3107, the Company had “uncovered what appears to be potential scientific misconduct and significant non-compliance with [Good Clinical Practices (“GCPs”)] and regulation at six sites,” which “may call into question the rigor, robustness and validity of the entire data set for [the study] and may require additional clinical studies to confirm the final results[.]”

On this news, BioVie’s stock price fell $1.25, or 29.3%, to close at $3.01 per share on November 9, 2023, thereby injuring investors.

Then, on November 29, 2023, BioVie disclosed that it had found “significant deviation from protocol and [GCP] violations” at 15 of its 39 testing sites, “virtually all of which were from one geographic area.” The Company stated that, due to the suspected improprieties, all patients from those sites would be excluded, leaving only 81 patients out the original 439.

On this news, BioVie’s stock price fell $3.03, or 60.7%, to close at $1.96 per share on November 29, 2023, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, 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, Defendants failed to disclose to investors that: (1) the ongoing COVID-19 pandemic caused “limited access” to clinical trial sites, significantly affecting the Company’s ability to conduct proper oversight of the clinical trial; (2) 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;” (3) the Company was experiencing issues with the CRO(s) it had retained, creating greater risk of the trial being in non-compliance with GCPs; (4) the Company had identified “higher than expected levels of deviations” in the data; (5) due to a “highly unusual level of suspected improprieties” there was a heightened risk a majority of the clinical trial subjects would be excluded; (6) as a result of the exclusions, there was a heightened material risk that the clinical trial would “not achieve statistical significance;” and (7) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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If you purchased BioVie securities during the Class Period, you may move the Court no later than March 19, 2024 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased BioVie securities, have information or 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 Frank R. Cruz, of The Law Offices of Frank R. Cruz, 2121 Avenue of the Stars, Suite 800, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of BioVie Inc. (BIVI) Investors