PHILADELPHIA, March 14, 2024 (GLOBE NEWSWIRE) -- Berger Montague advises investors that a securities fraud class action lawsuit has been filed against BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) on behalf of purchasers of BioVie’s securities between August 5, 2021 and November 29, 2023, inclusive (the “Class Period”).

Investor Deadline: Investors who purchased or acquired BioVie securities during the Class Period may, no later than March 19, 2024, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation, please contact Berger Montague: James Maro at jmaro@bm.net or (267) 637-3176, or Andrew Abramowitz at aabramowitz@bm.net or (215) 875-3015 or CLICK HERE.

BioVie is a clinical stage biopharmaceutical company headquartered in Carson City, NV. During the Class Period, BioVie conducted a Phase 3 clinical trial of NE3107, a drug being developed for the treatment of Alzheimer’s Disease.

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.

Learn More About the Lawsuit

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.

Berger Montague, with offices in Philadelphia, Minneapolis, Delaware, Washington, D.C., San Diego, San Francisco and Chicago, has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.

Contacts:

James Maro, Senior Counsel
Berger Montague
(267) 637-3176
jmaro@bm.net

Andrew Abramowitz, Senior Counsel
Berger Montague
(215) 875-3015
aabramowitz@bm.net