Stoke Therapeutics Announces Completion of Successful Meeting with the FDA to Align on Planned U.S. NDA for Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome (Businesswire) - Oct 5, 2026 - "The meeting provided an opportunity to discuss the 5 years of clinical safety and efficacy data from the Phase 1/2a and ongoing open-label extension (OLE) studies of zorevunersen and to obtain feedback on the planned NDA submission, including timing, data to be included and the analysis of Vineland-3 data....Following the discussion with the FDA, Stoke now plans to use a multicomponent assessment of four prespecified Vineland-3 subdomains to evaluate changes in cognition and behavior in the Phase 3 EMPEROR study....The Company plans to continue actively engaging with the FDA and to submit data throughout the first half of 2027 to support rapid completion of the NDA submission following the Phase 3 readout anticipated in the third quarter of 2027. With these data, the Company plans to complete the U.S. NDA submission in the second half of 2027 to support a potential U.S. approval and launch of zorevunersen in early 2028."
FDA approval • FDA event • FDA filing • Launch US • P3 data • CNS Disorders • Developmental Disorders • Genetic Disorders
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