The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Provention Bio, Inc. securities between November 2, 2020 and April 8, 2021, inclusive (the “Class Period”). Provention investors have until July 20, 2021 to file a lead plaintiff motion.
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, the Company published 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.
The complaint filed alleges that throughout the Class Period, 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 failed to disclose to investors that: (1) the teplizumab BLA was deficient in its submitted form and would require additional data to secure 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, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
If you purchased Provention securities during the Class Period, you may move the Court no later than July 20, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Provention securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to firstname.lastname@example.org, or visit our website at www.frankcruzlaw.com.