GlobeNewswire·Mar 30, 2026, 4:01 PM ET

Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

FDA accepted Praxis Precision Medicines' New Drug Application for relutrigine to treat SCN2A and SCN8A developmental and epileptic encephalopathies.
The FDA granted priority review status with a PDUFA target action date of September 27, 2026.
The NDA submission is supported by positive results from the EMBOLD study, which was stopped early for efficacy.
If approved, relutrigine would be the first disease-modifying therapy for SCN2A/8A DEEs, a condition with no currently approved targeted treatments.
Relutrigine holds Orphan Drug Designation, Rare Pediatric Disease Designation, and Breakthrough Therapy Designation from the FDA.
Approval could make relutrigine eligible for a Pediatric Review Voucher.
Relutrigine is also being investigated in broad DEEs via the EMERALD trial, expected to conclude by the end of 2026.
Relutrigine acts as a first-in-class small molecule that selectively inhibits persistent sodium current to reduce seizure activity.
Clinical data from the EMBOLD study showed improved motor seizures with a generally well-tolerated safety profile in heavily pre-treated patients.
Praxis Precision Medicines has four late-stage product candidates within its CNS portfolio.