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Oklahoma City, OK (April 16, 2019) – On April 12, 2019, a securities class action lawsuit was filed in the United States District Court for the Northern District of California against Zogenix, Inc. (NASDAQ: ZGNX). The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material or false misrepresentations to the market which had the effect of artificially inflating the market price during the Class Period, which is February 6, 2019 through April 8, 2019. More specifically, the complaint alleges that throughout the Class Period defendants made materially false and misleading statements regarding the company’s business, operational and compliance policies. Specifically, the complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that: (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.
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 received a refusal to file letter from the FDA regarding its NDA for FINTEPLA, for the treatment of 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 April 9, 2019 following this news, shares of Zogenix fell to close at $39.96, nearly a 23% from April 8, 2019.
Plaintiff seeks to recover damages on behalf of all Zogenix, Inc. shareholders who purchased common stock during the Class Period and are therefore a member of the Class as described above. You may move the Court no later than Tuesday, June 11, 2019 to serve as a lead plaintiff for the entire Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995.
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