The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of Nevada on behalf of those who acquired BioVie, Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities during the period of August 5, 2021 through November 29, 2023, inclusive (“the Class Period”). Investors have until March 19, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

On November 8, 2023, the Company filed its quarterly report with the SEC on Form 10-Q for the quarter ended September 30, 2023. The Company disclosed that routine monitoring of data from its Phase 3 clinical trial of NE3108, a molecule developed to treat mild to moderate Alzheimer's Disease, “uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites,” and that the “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.” Upon this news, the Company's share price declined by $1.25, or approximately 29.34%, from $4.26 per share to close at $3.01 on November 9, 2023. The lawsuit alleges that BioVie’s stock price remained artificially inflated as a result of Defendants’ failure to disclose the full extent of the adverse findings regarding the scientific misconduct and significant non-compliance with good clinical practices and regulations.

On November 29, 2023, BioVie, Inc. issued a press release and investor presentation revealing top line data from its NE3107 clinical trial. The trial, conducted during the COVID-19 pandemic, enrolled 439 patients across 39 sites. Post-trial, the Company identified protocol deviations and GCP violations at 15 sites, prompting the exclusion of 358 patients, or 80% of the enrolled population from the trial and referral of the excluded sites to the FDA's Office of Scientific Investigations. During a same-day conference call, Defendants disclosed that the Phase 3 trial lacked statistical significance due to excluded patients engaging in improper practices. Upon this news, the Company's share price declined by $3.03, or approximately 60%, from $4.99 per share to close at $1.96 on November 29, 2023.

The lawsuit alleges that Defendants, throughout the Class Period, misled investors by failing to disclose that (i) BioVie was not conducting proper oversight of its Phase 3 clinical trial; (ii) that the COVID-19 pandemic significantly and negatively impacted the Company's ability to adequately conduct proper oversight of the Phase 3 clinical trial; (iii) 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; (iv) 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 (v) 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 otherwise acquired BioVie securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: https://www.kmllp.com.

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