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Praxis Precision Medicines

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FDA designations

  • Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Relutrigine for the Treatment of Seizures Associated with SCN2A and SCN8A Developmental and Epileptic EncephalopathiesJul 21, 2025

News

  • Praxis Precision Medicines received FDA Breakthrough Therapy Designation for elsunersen in SCN2A-related developmental and epileptic encephalopathyJun 22, 2026
  • Praxis announced FDA acceptance of NDA for ulixacaltamide in essential tremorApr 14, 2026
  • FDA grants Breakthrough Therapy Designation to Praxis' ulixacaltamide for essential tremorDec 29, 2025
  • Praxis Precision Medicines plans NDA filing in early 2026 for Relutrigine in SCN2A/SCN8A developmental epileptic encephalopathiesDec 11, 2025
  • Praxis Precision Medicines aligns with FDA on simplified and accelerated registrational pathway for Elsunersen in early-onset SCN2A developmental and epileptic encephalopathyDec 10, 2025

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