February 13, 2020 - The case was voluntarily dismissed.

January 27, 2020 - The court dismissed the amended complaint with leave to amend.

October 4, 2019 - A motion to dismiss the amended complaint was filed.

September 10, 2019 - An amended complaint was filed.

April 12, 2019 - An investor in shares of Zogenix, Inc. (NASDAQ: ZGNX) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by Zogenix, Inc. in connection with certain allegedly false and misleading statements made between February 6, 2019 and April 8, 2019.

Emeryville, CA based Zogenix, Inc., a pharmaceutical company, develops and commercializes therapies for the treatment of transformative central nervous system disorders in the United States. Its lead product candidate is ZX008, which is also known commercially by its trademarked name “FINTEPLA.” FINTEPLA is 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, Inc. announced 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. Zogenix, Inc. told investors that “the FDA determined that the NDA... was not sufficiently complete 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.”

According to the complaint the plaintiff alleges on behalf of purchasers of Zogenix, Inc. (NASDAQ: ZGNX) common shares between February 6, 2019 and April 8, 2019, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between February 6, 2019 and April 8, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that Zogenix’s NDA for FINTEPLA contained inadequate non-clinical data and an incorrect version of a clinical dataset, that consequently, Zogenix’s NDA for FINTEPLA was unlikely to gain FDA approval, and that as a result, the Company’s public statements were materially false and misleading at all relevant times.