An investor, who purchased shares of BioVie Inc. (NASDAQ: BIVI), filed a lawsuit over alleged violations of Federal Securities Laws by BioVie Inc.
Investors who purchased shares of BioVie Inc. (NASDAQ: BIVI) have certain options and for certain investors are short and strict deadlines running. Deadline: March 19, 2024. NASDAQ: BIVI investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
Carson City, NV based BioVie Inc., a clinical stage biopharmaceutical company, engages in the discovery, development, and commercialization of drugs for the treatment of chronic debilitating conditions in the United States.
On November 8, 2023, BioVie Inc. filed its quarterly report with the SEC on Form 10-Q for the quarter ended September 30, 2023. BioVie Inc. disclosed that routine monitoring of data from its Phase 3 clinical trial of NE3108, a molecule developed to treat mild to moderate Alzheimer's Disease, "uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites," and that the "findings of potential scientific misconduct and significant GCP violations may call into question the rigor, robustness and validity of the entire data set for this study (NCT04669028) and may require additional clinical studies to confirm the final results of the study."
On November 29, 2023, BioVie, Inc. issued a press release and investor presentation revealing top line data from its NE3107 clinical trial. The trial, conducted during the COVID-19 pandemic, enrolled 439 patients across 39 sites. Post-trial, the Company identified protocol deviations and GCP violations at 15 sites, prompting the exclusion of 358 patients, or 80% of the enrolled population from the trial and referral of the excluded sites to the FDA's Office of Scientific Investigations. During a same-day conference call, Defendants disclosed that the Phase 3 trial lacked statistical significance due to excluded patients engaging in improper practices.
Shares of BioVie Inc. (NASDAQ: BIVI) declined from as high as $11.39 per share on March 16, 2023, to as low as $0.89 per share on January 26, 2024.
The plaintiff claims that between August 5, 2021 and November 29, 2023, the Defendants misled investors by failing to disclose that BioVie was not conducting proper oversight of its Phase 3 clinical trial, that the COVID-19 pandemic significantly and negatively impacted the Company's ability to adequately conduct proper oversight of the Phase 3 clinical trial, that due to lack of proper oversight and reliance on contract research organizations, the data from Defendants' Phase 3 clinical trial faced a greater risk of being unreliable and that the majority of patients would have to be excluded from the clinical trial, that, as a result of the significant exclusions from the trial results, the Phase 3 clinical trial would fail to meet its primary endpoints, and that statements about BioVie's business, operations, prospects, and compliance with current good clinical practices ("cGCP") were materially false and/or misleading and/or lacked a reasonable basis at all relevant times.
Those who purchased shares of BioVie Inc. (NASDAQ: BIVI) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
NASDAQ: BIVI Investor Alert: Lawsuit Alleges Misleading Statements by BioVie Inc.
A lawsuit was filed on behalf of investors in BioVie Inc. (NASDAQ: BIVI) shares over alleged securities laws violations.