In December Praxis received Breakthrough Therapy designation for ulixacaltamide and held a pre-NDA meeting with the FDA. The company has now submitted NDAs for ulixacaltamide in essential tremor and relutrigine for SCN2A/SCN8A developmental and epileptic encephalopathies.

Essential3 Study 1 met its primary endpoint and all key secondary endpoints including improvements in mADL11 and disease progression, while Study 2 achieved its prespecified primary endpoint during randomized withdrawal. Relutrigine EMBOLD data showed statistically significant seizure and developmental improvements, and Phase 2 RADIANT vormatrigine data demonstrated 58% seizure reduction at week 1 and sustained 100% median reduction by week 9.

The company is building launch infrastructure and has initiated key hires while planning a medical education event at AAN in April. Praxis estimates an addressable essential tremor population of 2 million patients out of 7 million U.S. cases with ulixacaltamide potential peak annual sales of over $10 billion, and forecasts roughly 10,000 patients for relutrigine initial indications with Rare Pediatric Disease voucher eligibility.

Top-line results for the POWER1 Phase 3 seizure study are expected in Q2 2026, with POWER2 enrollment completion by year-end and POWER3 initiation in H1 2026. EMBRAVE Part A data are due in H1 2026, full EMBRAVE3 enrollment is projected later in 2026, and a supplemental NDA for broader DEE expansion could follow in 2027.