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Submit Your Information for the BioVie Inc. Lawsuit

Lead plaintiff deadline is March 19, 2024.

If you purchased or acquired BioVie Inc. securities between August 5, 2021 and November 29, 2023, please contact Berger Montague using the form below.

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About the Case

On November 29, 2023, BioVie 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, the 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.

According to the lawsuit, the defendants misrepresented or failed to disclose that: (1) BioVie was not conducting proper oversight of its Phase 3 clinical trial; (2) the COVID-19 pandemic significantly and negatively impacted the Company’s ability to adequately conduct proper oversight of the Phase 3 clinical trial; (3) due to lack of proper oversight and reliance on contract research organizations, the data from the defendants’ Phase 3 clinical trial faced a heightened risk of being unreliable and a majority of patients would need to be excluded; and (4) as a result of the significant exclusions from the trial results, the Phase 3 clinical trial would fail to meet its primary endpoints.

Investors who purchased or acquired BioVie securities between August 5, 2021 and November 29, 2023, may no later than March 19, 2024, seek to be appointed as a lead plaintiff representative of the class.