Stoke announces global regulatory alignment for Phase 3 study of zorevunersen in Dravet syndrome

Stoke Therapeutics, Inc.

Aligned with FDA, EMA, and PMDA for Phase 3 EMPEROR; study to start mid-2025, data by end of 2027.
Primary endpoint: reduction in major motor seizure frequency; key secondary: cognition and behavior via Vineland-3.
Dosing: two 70mg loading doses then two 45mg maintenance doses over 52 weeks; ages 2 to <18.
Commercial opportunity: >38,000 patients with Dravet syndrome in seven major markets.
FDA Breakthrough Therapy designation; prior OLE data: 87% median seizure reduction at month 8.

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