Stoke Therapeutics said it has finished enrolling 162 patients in the phase 3 Emperor study of zorevunersen, setting up a rolling U.S. NDA submission in the first quarter of 2027.
The company said about 50 of the 162 patients in the U.S., U.K. and Japan have already reached the 28-week treatment point used to measure the primary endpoint, change in major motor seizure frequency. Another cohort of about 30 patients is still enrolling in Europe, with the last patient expected in August. No patients have discontinued treatment.
Stoke said the phase 3 data readout is expected in the third quarter of 2027, which would allow it to complete the rolling NDA submission in the second half of 2027. The company is targeting a U.S. launch by early 2028 if approved.
Enrollment took 10 months, according to the company. Stoke said the study’s planned primary analysis population includes 162 patients in the U.S., U.K. and Japan, while the additional European cohort is not planned for inclusion in the U.S. filing. Site activation is also underway in China.
Zorevunersen is being tested in children ages 2 to under 18 with Dravet syndrome. The study’s primary endpoint is percent change from baseline in major motor seizure frequency at week 28, with secondary endpoints assessed at week 52. Following these announcements, the company's shares moved 1.17%, and are now trading at a price of $32.77. Check out the company's full 8-K submission here.
