BioVie Inc. (BIVI) Allegedly Failed to Disclose Scientific Misconduct in Connection with its Clinical Trial

A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired BioVie (NASDAQ: BIVI) securities between August 5, 2021 and November 29, 2023. BioVie is a clinical stage biopharmaceutical company that purports to engage in the discovery, development, and commercialization of innovative drugs therapies, including for treatment of neurological and neurodegenerative disorders and advanced liver disease.

According to the complaint, on August 5, 2021, BioVie announced enrollment of the first patient in its Phase 3 study of NE3107 in Alzheimer's Disease. On November 29, 2023, defendants reported that the Phase 3 clinical trial “did not achieve statistical significance because we had to exclude so many patients from the trials that we believe engaged in improper practices.” Defendants further noted that BioVie had to exclude 358 patients, which represented “over 80% of our enrolled populations due to suspected improper conduct at 15 clinical sites,” and that “all of these clinical sites had been referred to the FDA.” On this news, the stock closed at $1.96, down more than 60% from the previous day’s closing price of $4.99.

Plaintiff alleges that during the class period, defendants failed to disclose 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; and (6) as a result of the exclusions, there was a heightened material risk that the clinical trial would “not achieve statistical significance.”

What Now: Similarly situated shareholders may be eligible to participate in the class action against BioVie Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP. Plaintiffs must file their lead plaintiff papers by March 19, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.