Stoke Therapeutics Inc. announced updates to the clinical development timeline for its lead investigational medicine, zorevunersen, which is being developed in collaboration with Biogen as a potential disease-modifying treatment for Dravet syndrome. The company now expects to complete enrollment of 150 patients in the Phase 3 EMPEROR study by the second quarter of 2026. A data readout from this study is anticipated in mid-2027 and is expected to support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Stoke Therapeutics plans to initiate a rolling NDA submission in the first half of 2027. Results from the Phase 3 EMPEROR study have not yet been presented. The company also noted ongoing discussions with the FDA regarding the expedited development and potential registration of zorevunersen.

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