Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the District of New Jersey on behalf of investors that purchased Provention Bio, Inc. (NASDAQ: PRVB) securities between November 2, 2020 and April 8, 2021, both dates inclusive (the “Class Period”). Investors have until July 20, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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Provention Bio is a clinical stage biopharmaceutical company. Provention Bio’s product candidates include, among others, PRV-031 teplizumab and monoclonal antibodies, in Phase III clinical trial for the interception of type one diabetes (“T1D”). In November 2020, Provention Bio 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, Provention Bio issued 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 alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Provention Bio’s teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval; (ii) accordingly, Provention Bio’s teplizumab BLA lacked the evidentiary support Provention Bio had led investors to believe it possessed; (iii) Provention Bio had thus overstated the teplizumab BLA’s approval prospects and hence the commercialization timeline for teplizumab; and (iv) as a result, Provention Bio’s public statements were materially false and misleading at all relevant times.

If you purchased Provention securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

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