Developmental and Epileptic Encephalopathy (SCN2A-DEE)
PRAXPraxis Precision MedicinesCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Elsunersen (PRAX-222) in Developmental and Epileptic Encephalopathy (SCN2A-DEE). The expected timing is based on the latest available company guidance and may change.
EMBRAVE, EMBRAVE3 trials. 2/28/25- Enrollment ongoing for 2nd cohort. EMBRAVE Part A topline data in H1 2026. 8/4/25- EMBRAVE3 registrational study: Initiated; Cohort 1 (ages 2–18) enrolling now. Presentation at IEC '25. 11/05/25:- Reiterated Ph1/2 EMBRAVE topline in H1 2026. 12/09/25:- EMBRAVE3 converted to single-arm; enrollment accelerating. EMBRAVE Part A topline in H1 2026; EMBRAVE3 topline 2026. 01/12/26:- EMBRAVE topline still expected H1 2026. EMBRAVE3 topline expected H2 2026; NDA filing planned 2027. 02/19/26:- EMBRAVE Part A topline on track H1 2026. EMBRAVE3 topline now expected in 2027. 04/06/26:- EMBRAVE Part A topline positive; 77% placebo-adjusted seizure reduction. More data to be presented at meetings. 04/13/26:- Emergency use program clinical updates to be presented at AAN 2026 on April 21, 2026. 05/07/26:- Detailed EMBRAVE Part A AAN data confirm robust seizure reductions; EMBRAVE3 enrollment progressing; topline results still expected 2027. 06/22/26:- FDA granted Breakthrough Therapy Designation. EMBRAVE3 single-arm registrational study enrolling ~30 patients. 08/06/26:- EMBRAVE3 enrollment progressing; topline expected in 2027.
Verification
Confirm timing and program details against the company announcement or filing.