Stoke Therapeutics Completes Enrollment Of 162 Patients Into Phase 3 EMPEROR Study Of Zorevunersen; Co Plans To Initiate Rolling NDA Submiss

—Company plans to initiate a rolling U.S.

NDA submission to the FDA in the first quarter of 2027— —Phase 3 data readout anticipated in the third quarter of 2027 to complete the rolling U.S.

NDA submission in the second half of 2027— Stoke Therapeutics, Inc. (NASDAQ: STOK ) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome.

The Company today announced the completion of enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen.

Stoke plans to initiate a rolling New Drug Application (NDA) submission to the U.S.

Food and Drug Administration (FDA) in the first quarter of 2027.

A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the rolling U.S.

NDA submission in the second half of 2027.

The EMPEROR study is progressing, and approximately 50 out of the 162 patients in the U.S., UK and Japan are through 28 weeks of treatment, the time point at which the primary endpoint of change in major motor seizure frequency is measured.

An additional cohort of approximately 30 patients in Europe is currently enrolling, and the last patient is expected to enroll in August.

No patients have discontinued treatment in the study.