A securities class action has been filed against Provention Bio, Inc. (PRVB) 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 through April 8,2021. This case has been filed in the USDC – NJ.
The Complaint alleges that on 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-).
Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, 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 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.
As a result of Defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.