NEW YORK, May 14, 2019 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Zogenix, Inc. ("Zogenix" or the "Company") (NASDAQ: ZGNX) and certain of its officers and directors. The class action, filed in United States District Court, United District Court, Northern District of California, and indexed under 19-cv-01975, is on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased or otherwise acquired Zogenix's securities between February 6, 2019 through April 8, 2019, both dates inclusive (the "Class Period"), seeking to recover damages caused by defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Zogenix securities, you have until June 11, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Zogenix is a pharmaceutical company that 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.
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, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Zogenix's NDA for FINTEPLA contained inadequate non-clinical data and an incorrect version of a clinical dataset; (ii) consequently, Zogenix's NDA for FINTEPLA was unlikely to gain FDA approval; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
On April 8, 2019, Zogenix announced that the Company had received a Refusal To File ("RTF") letter from the FDA stating that the Company's NDA for FINTEPLA was not sufficiently complete to permit a substantive review. 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 $11.89 per share, or nearly 23%, to close at $39.96 per share on April 9, 2019.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 9980
SOURCE Pomerantz LLP