We are investigating Zogenix, Inc. (ZGNX) (“Zogenix” or the “Company”) for potential violations of the federal securities laws.
On April 8, 2019, Zogenix announced that the Company had received a Refusal To File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for FINTEPLA, the Company’s proposed treatment for seizures associated with Dravet syndrome. Zogenix advised investors 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 sharply during intraday trading on April 9, 2019.