Investors with losses exceeding $100,000 are encouraged to contact the firm

The Law Offices of Frank R. Cruz reminds investors of the upcoming July 20, 2021 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased Provention Bio, Inc. ("Provention" or the "Company") (NASDAQ: PRVB) securities between November 2, 2020 and April 8, 2021, inclusive (the “Class Period”).

If you are a shareholder who suffered a loss, click here to participate.

In November 2020, Provention completed the rolling submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for teplizumab for the delay or prevention of clinical T1D in at-risk individuals (the “teplizumab BLA”).

On April 8, 2021, the Company published a press release “announc[ing] that the Company received a notification on April 2, 2021 from the [FDA], stating that, as part of its ongoing review of the Company’s [BLA] for teplizumab for the delay or prevention of clinical [T1D], the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”

On this news, Provention’s stock price fell $1.73 per share, or 17.78%, to close at $8.00 per share on April 9, 2021.

The complaint filed 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 teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval; (2) accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed; (3) the Company had thus overstated the teplizumab BLA’s approval prospects and hence the commercialization timeline for teplizumab; and (4) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.

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If you purchased or otherwise acquired Provention securities during the Class Period, you may move the Court no later than July 20, 2021 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20210716005004/en/

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Provention Bio, Inc. (PRVB)