Provention Bio, Inc.
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In November 2020, Provention completed the rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for teplizumab, for the delay or prevention of clinical T1D in at-risk individuals. On April 8, 2021, Provention published a press release “announc[ing] that the Provention received a notification on April 2, 2021 from the [FDA], stating that, as part of its ongoing review of the Provention for teplizumab for the delay or prevention of clinical, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”
On April 9, 2021, Provention’s stock price fell $1.73 per share, or 17.78%, on this news to close at $8.00 per share.
It is alleged in this complaint that, throughout the Class Period, Provention made materially misleading and/or false statements, as well as failed to disclose material adverse facts about the Provention’s business, operations, and prospects. Specifically, Provention failed to disclose to investors that: (1) the teplizumab BLA was deficient in its submitted form, requiring additional data in order to secure FDA approval; (2) accordingly, the teplizumab BLA lacked the evidentiary support Provention had led its investors to believe it possessed; (3) Provention had thus overstated the teplizumab BLA’s approval prospects, and hence the timeline of the commercialization of teplizumab; and (4) as a result, Provention’s statements about its business, operations, and prospects, were materially misleading and false and/or lacked a reasonable basis at all relevant times.