EMERYVILLE, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will host an Investor Update Lunch on its investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), on Monday, December 9, 2019, from 12:00 PM to 2:00 PM ET, at the American Epilepsy Society (AES) 2019 Annual Meeting in Baltimore.
The event will include a discussion of new data presented at the AES conference and a Key Opinion Leader will review the evidence of long-term neurocognitive improvements associated with seizure reduction demonstrated in the FINTEPLA® clinical studies.
Zogenix management team will provide updates on the ongoing expanded access program and open-label extension study with FINTEPLA and U.S. pre-launch preparation activities in anticipation of the potential approval of FINTEPLA in Dravet syndrome. In addition, management will present plans for exploring new potential indications for FINTEPLA.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the presentations will be accessible here.
About Zogenix
Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: investigational drug FINTEPLA® (ZX008, fenfluramine oral solution), for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. Zogenix’s New Drug Application for FINTEPLA for Dravet syndrome has been accepted for review by the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.
Forward-Looking Statement
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include the potential timing of top-line data for Zogenix’s Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACTS:
Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 | corpcomms@zogenix.com
Investors
Andrew McDonald
Founding Partner, LifeSci Advisors LLC
+1 (646) 597-6987 | Andrew@lifesciadvisors.com