Investigation of Provention Bio, Inc.

Provention Bio, Inc. (PRVB) Made Misstatements Regarding its Deteriorating Financial Condition

During the class period, the Company touted the FDA’s submission of a Biologics License Application (“BLA”) for teplizumab for the delay or prevention of T1D in at-risk individuals, and granted Provention’s request for Priority Review and assigned a user fee goal date of July 2, 2021, under the Prescription Drug User-Fee Act.  However, these statements were false and/or misleading in that they failed to disclose that: (i) the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval; (ii) the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed; and  (iii) the Company had overstated the teplizumab BLA’s approval prospects and the commercialization timeline for the drug.

On April 8, 2021, Provention issued a press release announcing that it had received “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 almost 18%, to close at $8.00 per share on April 9, 2021.


If you purchased shares of Provention Bio, Inc. (PRVB) between November 2, 2020 and April 8, 2021, you have until July 23, 2021, to ask the court to appoint you lead plaintiff for the class.

All representation is on a contingency fee basis.  Shareholders pay no fees or expenses.

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