Stoke Therapeutics Announces Completion of Phase 3 Enrollment (162 Patients)

What Happened
Stoke Therapeutics, Inc. (STOK) filed an 8-K on June 30, 2026 and issued a press release announcing completion of enrollment of 162 patients in its Phase 3 EMPEROR study of zorevunersen, a potential disease‑modifying treatment for Dravet syndrome. Enrollment was completed in the planned primary analysis population across the U.S., U.K., and Japan. Approximately 50 patients have reached 28 weeks of treatment, the timing for the trial’s primary endpoint (change in major motor seizure frequency). The company expects a Phase 3 data readout in the third quarter of 2027.

Key Details

• Total enrolled in EMPEROR primary analysis population: 162 patients.
• Patients at primary endpoint timepoint: ~50 have reached 28 weeks of treatment.
• Anticipated Phase 3 data readout: Q3 2027.
• Regulatory timeline: initiate rolling NDA submission to the FDA in Q1 2027; expect to complete the NDA submission in H2 2027.

Why It Matters
Completion of enrollment is a major clinical milestone that enables Stoke to proceed to primary efficacy analysis and to begin the planned NDA process. For investors, the Q3 2027 readout and the 2027 NDA submission timeline are the next concrete milestones to monitor for potential regulatory progress and value inflection. This 8-K is a disclosure of milestone progress; it does not provide efficacy or regulatory outcomes.