Stoke Therapeutics completes enrollment of 162 patients in Phase 3 EMPEROR; Q3 2027 readout, rolling NDA in 2027

Stoke Therapeutics completed enrollment of 162 patients in its Phase 3 EMPEROR study of zorevunersen and plans a rolling U.S. NDA starting Q1 2027.Key Highlights:Original SEC Filing: Stoke Therapeutics, Inc. [ STOK ] - 8-K - Jun. 30, 2026This is an AI-powered summary. It may contain inaccuracies. C…

Stoke Therapeutics completed enrollment of 162 patients in its Phase 3 EMPEROR study of zorevunersen and plans a rolling U.S. NDA starting Q1 2027.

Key Highlights:

Enrollment of 162 patients in planned primary analysis population across U.S., U.K. and Japan is complete.
Approximately 50 patients have reached 28 weeks, the primary endpoint timepoint for major motor seizure frequency.
Phase 3 data readout from these patients is anticipated in Q3 2027 to support the rolling NDA.
Company plans to initiate rolling U.S. NDA submission in Q1 2027 and complete the submission in H2 2027.
An additional ~30-patient cohort in Europe is enrolling (last patient expected in August); European and China patients not included in U.S. NDA.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.