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Stoke Therapeutics Announces Alignment with Global Regulatory Agencies

Stoke Therapeutics has achieved alignment with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the EMPEROR study, focusing on zorevunersen's effects on major motor seizure frequency, behavior, and cognition in children and adolescents.

Stoke Therapeutics has successfully aligned with global regulatory agencies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), for the EMPEROR study. This pivotal study will focus on zorevunersen, aiming to evaluate its effectiveness in reducing major motor seizure frequency and improving behavior and cognition in children and adolescents aged 2 to 18. The one-year study represents a significant step forward in understanding and potentially treating conditions associated with major motor seizures in young populations.
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Reference News

[1]
Stoke Therapeutics Announces Alignment with Global ...
nasdaq.com · Apr 5, 2024

Alignment with FDA, EMA, and PMDA for EMPEROR study. Zorevunersen's one-year study to assess seizure frequency reduction...

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