Why Are Zogenix's Shares Gaining Today?

The FDA has granted Priority Review to Zogenix Inc's 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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLong IdeasNewsSmall CapFDAMoversTrading IdeasGeneralBriefsLennox-Gastaut syndromewhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!