other material
confidence high
sentiment positive
materiality 0.75
Stoke completes enrollment of 162 patients in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome
Stoke Therapeutics, Inc.
- Completed enrollment of 162 patients in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
- Plans to initiate rolling NDA submission to FDA in Q1 2027; data readout anticipated in Q3 2027.
- Approximately 50 of 162 patients have passed 28-week primary endpoint measurement; no discontinuations.
- Additional cohort of ~30 patients enrolling in Europe; last patient expected in August.
- Potential FDA approval and U.S. launch by early 2028.