The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Zogenix, Inc. (Zogenix or the Company) (NASDAQ: ZGNX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Zogenix announced on April 8, 2019, that it had a refusal letter from the FDA regarding the Companys New Drug Application for FINTEPLA, its treatment for seizures caused by Dravet syndrome. The company admitted to investors, 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. Based on this news, shares of Zogenix fell almost 23% on April 9, 2019.
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The class in this case has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
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