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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Stoke Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260111172978) on January 11, 2026, and is solely responsible for the information contained therein.
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