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Why Are Zogenix's Shares Gaining Today?

The FDA has granted Priority Review to Zogenix Inc’s (NASDAQ:ZGNX) supplemental marketing application seeking approval for Fintepla (fenfluramine) in Lennox-Gastaut syndrome (LGS) childhood-onset epilepsy.

  • The agency’s Prescription Drug User Fee Act (PDUFA) target action date is March 25, 2022. 
  • The submission is based on data from the Phase 3 trial that demonstrated Fintepla at a dose of 0.7/mg/kg/day was superior to placebo in reducing the frequency of drop seizures (p=0.0012), as well as long-term safety and effectiveness data from Zogenix’s ongoing open-label extension trials.
  • Related Link: Zogenix’s Fintepla Shows Long-Term Seizure Frequency Reductions In Childhood Epilepsy.
  • In June 2020, FINTEPLA was approved by the FDA to treat seizures associated with Dravet syndrome in patients two years of age and older.
  • See here Benzinga’s Full FDA Calendar.
  • Price Action: ZGNX shares are up 11.30% at $12.52 during the market session on the last check Wednesday.

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