Stoke Therapeutics targets early 2028 U.S. launch for Dravet drug zorevunersen after FDA alignment meeting
STOK•Stoke Therapeutics said it aligned with the FDA on its planned U.S. NDA for zorevunersen to treat Dravet syndrome, targeting NDA completion in the second half of 2027 and a potential U.S. launch in early 2028. Phase 3 EMPEROR results are expected in the third quarter of 2027.
1. FDA alignment and timeline
Stoke Therapeutics aligned with the FDA on its planned U.S. NDA for zorevunersen in Dravet syndrome. The company plans data submissions through the first half of 2027 and is targeting NDA completion in the second half of 2027, with a potential U.S. launch in early 2028.
2. Evidence and assessment
The planned NDA package will include five years of safety and efficacy evidence from earlier studies, along with a revised assessment of cognition and behavior in the Phase 3 EMPEROR trial, intended to better capture meaningful patient change. EMPEROR results are expected in the third quarter of 2027.
