According to the Complaint, Provention Bio, Inc. 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 mAb, in Phase III clinical trial for the interception of T1D.
In November 2020, Provention completed the rolling submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration for teplizumab for the delay or prevention of clinical T1D in at-risk individuals.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose 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 had led investors to believe it possessed; (iii) the Company had thus overstated the teplizumab BLA's approval prospects and hence the commercialization timeline for teplizumab; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
On November 17, 2021, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed a consolidated amended Complaint on December 23.
Defendants filed a Motion to Dismiss the consolidated amended Complaint on February 8, 2022. On August 3, the Court issued an Order granting Defendants' Motion to Dismiss. The case was dismissed with prejudice.