Stoke Therapeutics Announces Third Quarter 2026 Financial Results and Provides Business Updates

Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics

“The Phase 3 EMPEROR study of zorevunersen continues to progress well. Approximately 110 of 162 enrolled patients have completed their Week 28 visit when the primary endpoint of change in major motor seizure frequency is measured and approximately 20 are through Week 52, the end of the treatment period. All 20 of these patients are continuing into the open-label extension period of the study and to date, no patients have discontinued treatment”

Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics

“Our NDA planning is on track following our recent discussion with the FDA. Importantly, the key secondary endpoint of changes in patients' cognition and behavior will be measured using a multicomponent assessment of four Vineland-3 subdomains. This multicomponent measure reflects the diversity of effects that people with Dravet syndrome experience and how to best evaluate them in a clinical trial. We look forward to the Phase 3 data readout in the third quarter of 2027 and completing our NDA submission in the second half of 2027.”

Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics

“Our second clinical program, STK-002, targets the protein haploinsufficiency that causes ADOA and therefore may have the potential to improve vision in people living with this severe genetic disease that often leads to blindness. Dosing in the first two cohorts is complete and dosing in the third cohort is underway with the fourth cohort expected to follow in early 2027. Safety and efficacy data are anticipated in the first half of 2027. With this progress across the business, we are building Stoke for the future with the team and capabilities to realize the full potential of zorevunersen, our pipeline and our unique scientific approach.”