Zogenix (ZGNX) Tops Q4 EPS by 51c

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Zogenix Provides Corporate Update and Reports Fourth Quarter and Full-Year 2018 Financial Results

February 28, 2019 4:02 PM EST

Completed rolling submission of an NDA to the U.S. FDA and an MAA to the EMA for FINTEPLA® for the treatment of seizures associated with Dravet syndrome in February 2019-- EMA has accepted MAA for review; outcome of the MAA review by the EMA expected in Q1 2020-- Notice regarding FDA acceptance of NDA filing and notification of PDUFA target date expected in next several weeks Continued to advance enrollment of global Phase 3 trial of FINTEPLA for the treatment of Lennox-Gastaut syndrome (Study... More