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Provention Bio, Inc.

Company NameProvention Bio, Inc.
Stock SymbolPRVB
Class PeriodNovember 02, 2020 to April 08, 2021
Lead Plaintiff Motion DeadlineJuly 20, 2021

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.

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