BioVie, Inc. (NASDAQ: BIVI)

Join This Class Action

NEW YORK, NY – January 24, 2024 – Wolf Haldenstein Adler Freeman & Herz LLP  announces that a federal securities class action lawsuit has been filed in the United States District Court for the District of Nevada on behalf of investors who purchased BioVie, Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”) securities. The complaint was brought on behalf of investors that incurred damages on their purchases in BioVie, Inc. securities between August 5, 2021 and November 29, 2023, inclusive.

All   investors who purchased shares. and incurred losses are urged to contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774.

If you have incurred losses in the you may, no later than March 19, 2024, request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in the shares of shares of BioVie Inc.

On August 30, 2021, the Company filed its annual report on Form 10-K, announcing the authorization of its Phase 3 trial for NE3107 on mild to moderate Alzheimer’s disease. On June 29, 2022, BioVie filed an Investor Presentation accompanying a Form 8-K. The Investor Presentation provided a description of the Phase 3 clinical trial, the mechanism of action for the drug candidate, as well as an update. The Investor Presentation specifically noted that “Phase 3 patient enrollment is underway; ramping to 45 centers; data readout anticipated mid-2023.” The slide further noted that the drug had “$10+ billion annual peak sales potential.” 

A slide presentation to the Form 8-K filed on September 7, 2022 provided a description of the Phase 3 clinical trial as well as an update. The Company specifically noted in the presentation that the trial had “enrolled one-half of targeted patients” and that “no drug related adverse events have been seen in daily medical reviews.” The update also stated that “DSMB will review data later this year to recommend whether the company should increase study size beyond targeted 316 patients.” 

On November 1, 2023, in a conference call to discuss the trial, the Company stated that “So we presented the data that we had as of October 18 from roughly 322 subjects, whose data were verified or in the process of being verified and cleaned as of this date…. And as we look at this pattern, we see great — we have some optimism that there is an effect, a drug effect going on.”

On November 8, 2023, the Company filed its quarterly report with the SEC on Form 10- Q for the quarter ended September 30, 2023, announcing that “[D]uring routine monitoring of blinded data from our Phase 3 study (NCT04669028) of NE3107, we uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites. We have alerted the FDA’s Office of Scientific Integrity (“OSI”) about these issues and believe OSI will perform a thorough, competent, objective and fair research of any potential scientific misconduct and non-compliance of GCPs and regulation.”

On November 9, 2023, the price of BioVie stock fell to a low of $2.31 per share, down from its closing price of $4.26 the day before. However, BioVie’s stock price remained artificially inflated as a result of Defendants’ failure to disclose the full extent of the adverse findings regarding the scientific misconduct and significant non-compliance with good clinical practices and regulations.

On November 29, 2023, BioVie filed a Form 8-K in which it found that there were significant deviations from protocol at 15 sites, meaning that of 439 patients in the study, all but 81 remained after exclusions. On that trading day, the stock closed at $1.96, down more than 60% from the previous day’s closing price of $4.99. 

Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country.  The firm has attorneys in various practice areas; and offices in New York, Chicago, and San Diego.  The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.

If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735, via e-mail at classmember@whafh.com, or visit our website at  www.whafh.com.

Contact:

Wolf Haldenstein Adler Freeman & Herz LLP

Patrick Donovan, Esq.

Gregory Stone, Director of Case and Financial Analysis

Email: gstone@whafh.com or classmember@whafh.com

Tel: (800) 575-0735 or (212) 545-4774

 

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

 


Certification and Authorization Pursuant to Federal Securities Laws

  • The individual or entity listed below requests Wolf Haldenstein Adler Freeman & Herz LLP to file an action or motion for appointment as lead plaintiff and lead counsel under the federal securities laws to recover damages and to seek other relief against BioVie, Inc. (NASDAQ: BIVI). Wolf Haldenstein Adler Freeman & Herz LLP will not do so until you complete a retainer agreement authorizing us to prosecute the action on a contingent fee basis.

  • I, individually or on behalf of the entity I represent ("I"), hereby certify as follows:

    1. I have reviewed the complaint and authorize the filing of a lead plaintiff motion or action on my behalf.
    2. I did not acquire the security that is the subject of this action at the direction of the Firm or in order to participate in this private action or any other litigation under the federal securities laws.
    3. I am willing to serve as a representative party on behalf of a class, including providing testimony at deposition and trial, if necessary.
    4. I represent and warrant that I am fully authorized to enter into and execute this certification.
    5. I will not accept any payment for serving as a representative party on behalf of the class beyond my pro rata share of any recovery, except such reasonable costs and expenses (including lost wages) directly relating to the representation of the class as ordered or approved by the court.
    6. I have made no transaction(s) during the Class Period in the debt or equity securities that are the subject of this action except those set forth below:
  • Type of SecurityBuy Date (mm/dd/yy)# of SharesPrice per Share 
  • Type of SecuritySell Date (mm/dd/yy)# of SharesPrice per Share 
  • Signed pursuant to California Civil Code Section 1633.1, et seq. - and the Uniform Electronic Transactions Act as adopted by the various states and territories of the United States.

Date of signing: 02/22/2024