Short answer
Stoke Therapeutics, Inc. (STOK) filed an 8-K current report with the SEC on June 30, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Phase 3 EMPEROR enrollment completed with 162 Dravet syndrome patients.
Stoke Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Phase 3 EMPEROR enrollment completed with 162 Dravet syndrome patients
- Zorevunersen advances toward efficacy and safety readout as a potential disease-modifying treatment
- Enrollment completion reduces trial execution risk but leaves clinical outcomes and regulatory approval uncertain
- Press release furnished under Regulation FD and not filed under Exchange Act Section 18 liability provisions
Item 8.01 · Other Events
- EMPEROR enrollment completed with 162 patients across the U.S., U.K., and Japan
- Primary endpoint measures change in major motor seizure frequency after 28 weeks
- Approximately 50 patients have reached the 28-week assessment milestone
- Phase 3 data readout anticipated in Q3 2027
- Rolling FDA NDA submission planned for Q1 2027, with completion expected in H2 2027
Item EX-99.1 · Exhibit EX-99.1
- Phase 3 EMPEROR enrollment completed with 162 patients, reducing execution risk for zorevunersen’s pivotal Dravet syndrome program
- Approximately 50 patients reached the Week 28 primary endpoint assessment; no treatment discontinuations reported
- Rolling U.S. NDA submission planned for first quarter 2027, with Phase 3 readout expected in third quarter 2027
- Potential U.S. launch targeted for early 2028, contingent on positive data and FDA approval
- European cohort of approximately 30 patients and China sites support broader development but are excluded from the planned U.S. NDA submission
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