Provention Bio, Inc.

  • Active

Investigation
04/08/2021

Initial Lawsuit
05/21/2021

Lawsuit Progression
11/17/2021

Investigation

  • Continous Holding
    November 2, 2020 to April 8, 2021
  • Proposed Claim
    Securities Violation

Investigation regarding Provention’s license application for teplizumab to the FDA and subsequently identified deficiencies.

Main Event

Teplizumab BLA: Deficiencies

04/08/2021

Company Statement

Provention issues a press release providing regulatory updates on the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for Teplizumab, the company’s candidate for the delay or prevention of clinical type one diabetes in at-risk individuals:

“the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. . . . The FDA indicated that based on the data it has reviewed to date, the Agency’s position is that the [pharmacokinetic] (PK) profiles of the two drug products evaluated in the [pharmacokinetic/pharmacodynamic] (PK/PD) bridging study were not comparable and that additional data would be required before the FDA’s considerations could be satisfied.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$8 $9.73 $-1.73 -17.83%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 05/21/2021

This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Provention securities between November 2, 2020 and April 8, 2021, bothdates inclusive.

  • Filing Date
    05/21/2021
  • Class Period
    11/02/2020 to 04/08/2021
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
  • Case Title
    Paxton v. Provention Bio, Inc.
  • Docket Number
    3:21-cv-11613
  • Court
    New Jersey District Court
  • Free File
    Complaint

Allegations

According to the complaint, 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 allegedly failed to disclose to investors that:

(i) the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval;
(ii) accordingly, the teplizumab BLA lacked the evidentiary support the Company hadled investors to believe it possessed;
(iii) the Company had thus overstated the teplizumab BLA’s approval prospects and hence the commercialization timeline for teplizumab;
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

Defendants

  • Company
    Provention
  • Chief Executive Officer
    Ashleigh Palmer
  • Chief Financial Officer
    Andrew Drechsler

Lawsuit progression

  • Docket Number
    3:21-cv-11613
  • Court
    New Jersey District Court

Lead Counsel

11/17/2021

The court issued an order appointing the lead plaintiff and lead counsel.

Amended Complaint

12/23/2021

This is a federal securities class action on behalf of a class consisting of all persons and entities other than defendants (as defined in the complaint) that purchased or otherwise acquired Provention securities between November 2, 2020 and July 6, 2021, both dates inclusive.

  • Updated Class Period
    11/02/2020 to 07/06/2021
  • Free File
    Amended Complaint

    • Operative complaint

Motion to Dismiss

02/08/2022

A motion to dismiss was filed with the court.

[stockdio-historical-chart symbol=”PRVB” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

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