Zogenix, Inc.

On April 8, 2019, Zogenix announced that it received a refusal to file letter from the U.S. Food and Drug Administration (“FDA”) regarding Zogenix’s new drug application (“NDA”) for FINTEPLA, Zogenix’s proposed treatment for seizures associated with Dravet syndrome. The FDA determined that the NDA was not sufficiently complete to permit a substantive review because certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine, and the application contained an incorrect version of a clinical dataset. On this news, shares of Zogenix fell $11.89 or nearly 23% to close at $39.96 per share on April 9, 2019, thereby injuring investors.

The complaint filed in this class action 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: (1) Zogenix’s NDA for FINTEPLA contained inadequate non-clinical data and an incorrect version of a clinical dataset; (2) consequently, Zogenix's NDA for FINTEPLA was unlikely to gain FDA approval; and (3) as a result, the Company's public statements were materially false and misleading at all relevant times.