Stoke Therapeutics receives FDA Breakthrough Therapy Designation for zorevunersen in Dravet syndrome

Stoke Therapeutics, Inc.

FDA granted Breakthrough Therapy Designation for zorevunersen to treat Dravet syndrome with a confirmed SCN1A mutation.
Phase 1/2a data showed 85% median reduction in convulsive seizure frequency at 3 months post-last dose of 70mg.
OLE study patients on 45mg maintenance achieved 87% median reduction in seizures at month eight.
Patients showed continuous improvements in cognition and behavior through 2 years of treatment per Vineland-3.
Company plans to provide Phase 3 registrational study update by end of 2024.

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