Company: Zogenix, Inc.
Class Period: February 6, 2019 — April 8, 2019
Court: U.S.D.C. – Northern District of California
Deadline: June 11, 2019
A shareholder class action complaint has been filed against Zogenix, Inc. (“Zogenix”) on behalf of investors who purchased shares of the Company’s stock between February 6, 2019 and April 8, 2019 (the “Class Period”).
According to the complaint, Zogenix’s lead product candidate is ZX008 (“FINTEPLA”), a low-dose fenfluramine that is in Phase III clinical trials for the treatment of seizures associated with Dravet syndrome. On February 6, 2019, Zogenix announced the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for FINTEPLA.
On April 8, 2019, Zogenix announced that it had received a Refusal To File (“RTF”) letter from the FDA stating that the Company’s NDA for FINTEPLA was not sufficiently complete to permit a substantive review. Zogenix further disclosed that “the FDA determined that the NDA … was not sufficiently completed to permit a substantive review…. [F]irst, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA.” On this news, Zogenix’s stock price fell $11.89 per share, or nearly 23%, to close at $39.96 per share on April 9, 2019.
The complaint alleges that the defendants made false and misleading statements and/or failed to disclose material adverse information to investors during the Class Period concerning the Company’s business, operations and compliance policies. Specifically, the defendants failed to disclose or indicate that: (i) Zogenix’s NDA for FINTEPLA contained inadequate non-clinical data and an incorrect version of a clinical dataset; and (ii) consequently, Zogenix’s NDA for FINTEPLA was unlikely to gain FDA approval.
IMPORTANT DEADLINE: Zogenix investors may, no later than June 11, 2019, seek to be appointed as a lead plaintiff representative of the class.
For additional information about this action, or to discuss your legal rights and options with respect to this action, please contact Kaskela Law LLC at (888) 715 – 1740 or complete the information form on this page.