India, Aug. 7 -- With four late-stage assets, three FDA Breakthrough Therapy Designations, and two upcoming PDUFA decisions, Praxis Precision Medicines (PRAX), a CNS precision neuroscience biopharmaceutical company, is entering a defining chapter.
The two drug candidates under FDA review are Ulixacaltamide and Relutrigine.
Relutrigine, proposed for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs), is under priority review, with the FDA decision due on December 27, 2026.
SCN2A and SCN8A-DEEs are rare genetic forms of epilepsy that begin in infancy, causing severe, treatment-resistant seizures and developmental impairment.
Relutrigine is also being investigated as a treatment for broad DEEs in a Phase 3...