Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the District of New Jersey on behalf of purchasers of Provention Bio, Inc. (NASDAQ: PRVB) securities between November 2, 2020 and April 8, 2021, inclusive (the “Class Period”). The case is captioned Paxton v. Provention Bio, Inc., No. 21-cv-11613. The Provention Bio class action lawsuit charges Provention Bio and certain of its executives with violations of the Securities Exchange Act of 1934.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Provention Bio securities during the Class Period to seek appointment as lead plaintiff in the Provention Bio class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Provention Bio class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Provention Bio class action lawsuit. An investor’s ability to share in any potential future recovery of the Provention Bio class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Provention Bio class action lawsuit or have questions concerning your rights regarding the Provention Bio class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Provention Bio class action lawsuit must be filed with the court no later than July 20, 2021.

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”).

The Provention Bio class action lawsuit 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.

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 Bio’s stock price fell nearly 18%, damaging investors.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. ISS Securities Class Action Services has ranked Robbins Geller as one of the top law firms in the world in both amount recovered and total number of class action settlements for shareholders every year since 2010. The SCAS 2020 Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other plaintiffs’ firm. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.

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