Case: Zogenix, Inc.
Venue: Northern District of California
Class Period: 2/6/2019 - 4/8/2019
Lead Plaintiff Deadline: 6/11/2019
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NEW YORK, NY – April 15, 2019 – Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating claims on behalf of investors who purchased shares of Zogenix, Inc. (NASDAQ: ZGNX), a pharmaceutical company developing rare disease therapies.  Investors who purchased Zogenix securities between February 6, 2019 and April 8, 2019, inclusive (the “Class Period”), may be affected.  A complaint has been filed in the United States District Court for the Northern District of California against the Company, its Chief Executive Officer, and its Chief Financial Officer.

On February 6, 2019, Zogenix issued a press release announcing that it had completed its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for FINTEPLA® (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome.

On April 8, 2019, after the market closed, Zogenix issued a press release announcing the receipt of a Refusal to File letter from the FDA regarding its NDA for FINTEPLA.  Among other things, the press release stated that “the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review.”  Further, the Company said that  “[i]n the letter, the FDA cited two reasons for the RTF decision: first, 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 April 9, 2019, Zogeniz’s shares fell $11.89 per share, about 23%, to close at $39.96 per share on heavy trading volume.

If you are a member of the proposed Class, you may move the court no later than June 11, 2019 to serve as a lead plaintiff for the purported class.  You need not seek to become a lead plaintiff in order to share in any possible recovery.  If you would like to discuss the complaint or our investigation, please contact us by emailing This e-mail address is being protected from spambots. You need JavaScript enabled to view it or by calling 800-290-1952.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.  If you have any questions about this Notice, the action, your rights, or your interests, please contact: 

Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400 
San Francisco, California  94104
(415) 772-4700
Fax:  (415) 772-4707
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