Zogenix (ZGNX) Misses Q3 EPS by 20c

Zogenix (NASDAQ: ZGNX) reported Q3 EPS of ($1.08), $0.20 worse than the analyst estimate of ($0.88).

“Following the completion of our positive, confirmatory Study 1504 Phase 3 trial of our investigational drug, FINTEPLA, in patients with Dravet syndrome, we began submission of a New Drug Application (NDA) for rolling review by the U.S. Food and Drug Administration (FDA) under a previously agreed NDA rolling submission plan,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We also recently held a successful pre-NDA meeting with the FDA to discuss certain aspects of the FINTEPLA NDA. Based on discussions at the meeting, we will conduct some additional analyses of our clinical data that could positively impact our product label. As a result, we now anticipate that the submission of the final sections of the NDA will occur in early first quarter 2019 versus the previously anticipated end of this year. Our centralized Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) will occur shortly following the NDA submission.”

“In parallel to our work on regulatory submissions, we continue to actively prepare for the potential launch of FINTEPLA in the U.S. and Europe,” continued Dr. Farr. “Moreover, we are pleased with the pace of enrollment in our Phase 3 trial of FINTEPLA in Lennox-Gastaut Syndrome (LGS), Study 1601. There are over 30 sites open for patient enrollment, primarily located in the U.S, and we are now focused on the addition of study sites in Europe and Japan over the next several months. With our recently completed public offering raising $293 million in net proceeds, we believe Zogenix is now in a strong position to create significant long-term shareholder value with our advancing FINTEPLA programs in Dravet syndrome, Lennox Gastaut syndrome and other pipeline program opportunities.”

For earnings history and earnings-related data on Zogenix (ZGNX) click here.

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