San Diego, CA -- (SBWIRE) -- 06/08/2021 -- An investor, who purchased NASDAQ: PRVB shares , filed a against Provention Bio, Inc. over alleged violations of Federal Securities Laws.

Investors who purchased shares of Provention Bio, Inc. (NASDAQ: PRVB) have certain options and for certain investors are short and strict deadlines running. Deadline: July 20, 2021. NASDAQ: PRVB investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Red Bank, NJ based Provention Bio, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics and solutions to intercept and prevent immune-mediated diseases. The Company'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, Inc. 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, Inc. 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."

Shares of Provention Bio, Inc. (NASDAQ: PRVB) declined to as low as $6.36 per share on April 09, 2021.

The plaintiff claims that between November 2, 2020 and April 8, 2021, the defendants made false and/or misleading statements and/or failed to disclose that the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval, that accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed, that the Company had thus overstated the teplizumab BLA's approval prospects and hence the commercialization timeline for teplizumab, and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Provention Bio, Inc. (NASDAQ: PRVB) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.