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Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies

  • The FDA extended the review period for Praxis Precision Medicines' New Drug Application for relutrigine by three months.
  • The updated PDUFA target action date is now December 27, 2026, moved from September 27, 2026.
  • The extension was triggered by Praxis submitting additional sensitivity analyses, which the FDA classified as a "major amendment."
  • No new clinical studies were requested, and the FDA cited no safety or manufacturing concerns regarding the application.
  • Relutrigine is being developed for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).
  • Praxis remains confident in the data package and continues to prepare for the potential commercial launch of relutrigine.