May 21, 2021 - An investor in shares of Provention Bio, Inc. (NASDAQ: PRVB) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Provention Bio, Inc. in connection with certain allegedly false and misleading statements made between November 2, 2020 and April 8, 2021.
Red Bank, NJ based Provention Bio, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics and solutions to intercept and prevent immune-mediated diseases.
The Company's product candidates include, among others, PRV-031 teplizumab and monoclonal antibodies, in Phase III clinical trial for the interception of type one diabetes ("T1D").
In November 2020, Provention Bio, Inc. 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, Provention Bio, Inc. 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."
Shares of Provention Bio, Inc. (NASDAQ: PRVB) declined to as low as $6.36 per share on April 09, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of Provention Bio, Inc. (NASDAQ: PRVB) common shares between November 2, 2020 and April 8, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between November 2, 2020 and April 8, 2021, the defendants made false and/or misleading statements and/or failed to disclose that the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval, that accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed, that the Company had thus overstated the teplizumab BLA's approval prospects and hence the commercialization timeline for teplizumab, and that as a result, the Company's public statements were materially false and misleading at all relevant times.