Quarterly ResultApr 6, 2026, 04:26 PM
Praxis Precision Medicines Announces Positive Topline Results for Elsunersen in SCN2A DEE Trial and FDA Priority Review for Relutrigine
AI Summary
Praxis Precision Medicines announced positive topline results from the EMBRAVE Part A trial of elsunersen, showing a 77% placebo-adjusted seizure reduction in pediatric patients with SCN2A DEE. Additionally, the FDA has accepted for priority review the New Drug Application for relutrigine for the treatment of SCN2A and SCN8A DEEs, with a target action date of September 27, 2026. These developments represent significant progress in Praxis's pipeline and potential treatments for rare neurological disorders.
Key Highlights
- Elsunersen treatment led to a 77% placebo-adjusted seizure reduction (p=0.015) in EMBRAVE Part A trial.
- 57% of elsunersen patients had at least a 28-day period of seizure freedom.
- FDA accepted for priority review the NDA for relutrigine with a target action date of September 27, 2026.