NasdaqGS:PRAXBiotechs
How Investors May Respond To Praxis (PRAX) FDA Priority Review For Rare Pediatric Epilepsy Drug
Praxis Precision Medicines recently announced that the FDA has accepted for priority review its New Drug Application for relutrigine to treat SCN2A and SCN8A developmental and epileptic encephalopathies, with a PDUFA target action date of September 27, 2026.
This filing, backed by positive EMBOLD trial data and multiple FDA and EMA designations, positions relutrigine as a potential first approved therapy for these rare, severe childhood epilepsies and could expand Praxis’s role in precision...