If you invested in BioVie and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses »

08/05/2021 - 11/29/2023


Complaint 01/19/24



The litigation focuses on the propriety of BioVie’s disclosures concerning its adherence to Good Clinical Practice (“GCP”) and protocols related to its Phase 3 clinical trial of NE3107, a potential Alzheimer’s disease drug.

On Aug. 5, 2021, BioVie announced that it enrolled the first patient in its Phase 3 clinical trial of NE3107 and thereafter assured investors that the “[t]rial continues to have a good safety profile and low discontinuation rate.”  On Sep. 26, 2023, BioVie announced completion of the last treatment visit in the trial and investors eagerly awaited the results for a drug, which the company touted as having a “10+ billion annual peak sales potential.”

The complaint alleges BioVie made misleading statements and concealed 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 oversight of the trial; (3) due to lack of proper oversight and reliance on contract research organizations, the data from the trial faced a greater risk of being unreliable and that the majority of patients would have to be excluded from it; and (4) as a result of the significant exclusions, the trial would fail to meet its primary endpoints.

The truth began to emerge on Nov. 8, 2023, when BioVie revealed that “during routine monitoring of blinded data from our Phase 3 study of […] NE3107, we uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulations at six sites[]” and “[w]e have alerted the FDA’s Office of Scientific Integrity (‘OSI’) about these issues[.]” This news drove the price of BioVie shares down $1.25, or almost 30% lower, on Nov. 9, 2023.

Then, on Nov. 29, 2023, BioVie announced that the Phase 3 trial missed statistical significance “due to site exclusions” and blamed the miss on “significant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites” leading it to exclude all patients from these sites and referrals of them to the OSI. On an event call, BioVie’s management suggested that the company became aware of Phase 3 deviations beginning as early as July 2023. This news drove the price of BioVie shares crashing $3.03, or over 60% lower, on Nov. 29, 2023.


What is the BIVI securities class-action case about?

The litigation focuses on the propriety of BioVie’s disclosures concerning its adherence to Good Clinical Practice (“GCP”) and protocols related to its Phase 3 clinical trial of NE3107, a potential Alzheimer’s disease drug.


I worked at BIVI. What should I do?

If you were an employee of BIVI during the period relevant to the class-action case, you may have valuable information that could be relevant to the lawsuit. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or BIVI@hbsslaw.com.

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions


What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.


Am I affected? What do I need to do to participate?

If you were an investor in BIVI during the relevant period specified in the class-action lawsuit, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any BIVI investor participate?

In most class-action cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This class-action only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.

Media Images

Hagens Berman purchases advertisements on search engines, social media sites and other websites. Transmission of the information contained or available through this website is not intended to create, and receipt does not constitute, an attorney-client relationship. If you seek legal advice or representation by Hagens Berman, you must first enter a formal agreement. All information contained in any transmission is confidential and Hagens Berman agrees to protect information against unauthorized use, publication or disclosure. This site is regulated by the Washington Rules of Professional Conduct.