Law Offices of Howard G. Smith reminds investors of the upcoming March 19, 2024 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities between August 5, 2021 through November 29, 2023, inclusive (the “Class Period”).

Investors suffering losses on their BioVie investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.

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.

If you purchased or otherwise acquired 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 if you meet certain legal requirements. To be a member of the class action 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 action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

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