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

Law Offices of Howard G. Smith announces that a class action lawsuit has been 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”). Provention investors have until July 20, 2021 to file a lead plaintiff motion.

Investors suffering losses on their Provention investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.

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.

If you purchased Provention securities, have information or 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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

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/20210527005156/en/

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Provention Bio, Inc. (PRVB) Investors