Stoke Therapeutics Completes FDA Meeting on Planned Zorevunersen NDA

MT newswire2026/10/05 12:12

08:12 AM EDT, 10/05/2026 (MT Newswires) -- Stoke Therapeutics (STOK) said Monday it has completed a successful meeting with the US Food and Drug Administration on key aspects of its planned submission of a new drug application for zorevunersen, its investigational treatment for Dravet syndrome. Following the meeting, Stoke said it plans to use a multicomponent assessment of four Vineland-3 subdomains to evaluate changes in cognition and behavior in a phase 3 study. The subdomains are expressive communication, receptive communication, interpersonal relationships, and personal skills, it said. The company expects a phase 3 readout in Q3 2027 and plans to submit a new US NDA application in H2 2027. The company said it plans to continue providing data to the FDA during the first half of 2027 to support the filing. Shares of the company were 1.5% higher in Monday premarket activity.

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