BioVie Inc.

On November 8, 2023, BioVie disclosed that, for the Phase 3 clinical trial of its Alzheimer’s treatment, NE3107, the Company had “uncovered what appears to be potential scientific misconduct and significant non-compliance with [Good Clinical Practices (“GCPs”)] and regulation at six sites,” which “may call into question the rigor, robustness and validity of the entire data set for [the study] and may require additional clinical studies to confirm the final results[.]”

On this news, BioVie’s stock price fell $1.25, or 29.3%, to close at $3.01 per share on November 9, 2023, thereby injuring investors.

Then, on November 29, 2023, BioVie disclosed that it had found “significant deviation from protocol and [GCP] violations” at 15 of its 39 testing sites, “virtually all of which were from one geographic area.” The Company stated that, due to the suspected improprieties, all patients from those sites would be excluded, leaving only 81 patients out the original 439.

On this news, BioVie’s stock price fell $3.03, or 60.7%, to close at $1.96 per share on November 29, 2023, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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; (6) as a result of the exclusions, there was a heightened material risk that the clinical trial would “not achieve statistical significance;” and (7) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.