Full Press Release Details
SAN FRANCISCO, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Hagens Berman urges BioVie Inc. (NASDAQ: BIVI) investors who suffered substantial losses to submit your losses now.
Class Period: Aug. 5, 2021 – Nov. 29, 2023
Lead Plaintiff Deadline: Mar. 19, 2024
Contact An Attorney Now: BIVI@hbsslaw.com
BioVie Inc. (BIVI) Securities Class Action:
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.
“We’re focused on investors’ losses and are investigating whether BioVie may have intentionally concealed GCP and protocol violations,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in BioVie and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the BioVie case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding BioVie should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new 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, call Reed Kathrein at 844-916-0895 or email BIVI@hbsslaw.com.
Hagens Berman is a global plaintiffs’ rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
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Reed Kathrein, 844-916-0895
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