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Praxis Says FDA Grants Breakthrough Therapy Designation to Relutrigine to Treat Seizures
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Praxis Says FDA Grants Breakthrough Therapy Designation to Relutrigine to Treat Seizures
Jul 17, 2025 6:10 AM

08:56 AM EDT, 07/17/2025 (MT Newswires) -- Praxis Precision Medicines ( PRAX ) said Thursday the US Food and Drug Administration has granted breakthrough therapy designation to relutrigine to treat seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies.

The designation was based on phase 2 trial data and results from an open-label extension study, which showed an average 90% reduction in seizures and a mean seizure-free period of 67 days, the company said.

Praxis said more than 30% of patients achieved seizure freedom during the trial's double-blind phase.

Shares of Praxis were up more than 4% in Thursday premarket activity.

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