Provention Bio, Inc.

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Case Summary
Company Name: Provention Bio, Inc.
Stock Symbol : NASDAQ: PRVB
Class Period Start: 11/02/2020
Class Period End: 04/08/2021
Lead Plaintiff motion: 07/20/2021
Date Filed: 05/25/2021
Type of Case: Securities Class Action
Court: U.S. District Court for the District of New Jersey
Summary:

Thieler Law Corp advises investors with losses exceeding $100,000 of the July 20, 2021 lead plaintiff deadline in a class action lawsuit filed against Provention Bio, Inc. (NASDAQ: PRVB) (Provention Bio, Inc. or “the Company”). The suit is pending in the U.S. District Court for the District of New Jersey and investors, who purchased Provention Bio, Inc. securities between November 2, 2020 and April 8, 2021 , have until July 20, 2021 to move for lead plaintiff. You do not need to move for lead plaintiff to be a member of the Class.

If you purchased Provention Bio, Inc. securities during the Class Period, and have losses over $100,000, you may contact Thieler Law Corp by calling at (619) 377 - 4324 or emailing mail@thielerlaw.com . No class has been certified in this case, and if your losses are less than $100,000 you are still a member of the class.

 

Provention is a clinical stage biopharmaceutical company that 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 (“mAb”), in Phase III clinical trial for the interception of type one diabetes (“T1D”).

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, Provention 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.

 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) the teplizumab Biologics License Application (“BLA”) was deficient in its submitted form and would require additional data to secure U.S. Food and Drug Administration (“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, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

 

If you were negatively impacted by your investment in Provention Bio, Inc. (NASDAQ: PRVB securities between November 2, 2020 and April 8, 2021 and would like to learn more about this lawsuit and your ability to participate as a lead plaintiff, please contact us for your no-cost evaluation.

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