Praxis Precision Medicines

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First targeted therapy for severe childhood epilepsy nears FDA approval

As of May 2026: Transitioning from clinical-stage to commercial-stage with two NDA submissions under FDA review

Children with SCN2A and SCN8A developmental and epileptic encephalopathies have never had a drug designed for their condition, cycling through four or more unapproved medications as seizures persist and development regresses. The FDA accepted Praxis Precision Medicines' application for relutrigine and granted priority review, with a decision expected by September 27, 2026.

Updated May 30