Provention Bio, Inc.
On April 8, 2021, Provention issued a press release stating “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.” This means that the Company’s lead drug under development would not make it to market as outlined in previous statements by Provention.
On this news, shares of Provention fell $1.73 per share, or 17.78%, to close at $8.00 per share on April 9, 2021.
The complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (i) the teplizumab BLA was deficient in its submitted form and would require additional data to secure FDA approval; (ii) accordingly, the teplizumab BLA lacked the evidentiary support the Company had led investors to believe it possessed; (iii) the Company had thus overstated the teplizumab BLA’s approval prospects and hence the commercialization timeline for teplizumab; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
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