Stoke Therapeutics, a biotechnology company, updates timelines for the completion of enrollment of 150 patients in Q2 2026 and a Phase 3 data readout in mid-2027 for the EMPEROR study on Zorevunersen for Dravet Syndrome.
Discussions ongoing with FDA for potential expedited development and delivery of Zorevunersen to patients.
Company to present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026.
Timeline Updates
Enrollment completion of 150 patients expected in Q2 2026, with a Phase 3 data readout in mid-2027.
FDA Discussions
Ongoing discussions with FDA for potential expedited regulatory pathways for Zorevunersen.
Financial Strength
Stoke Therapeutics has approximately $391.7 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
- The accelerated enrollment progress positions the Phase 3 EMPEROR study on track for a data readout in mid-2027, supporting the submission of a New Drug Application to the FDA.
- Ongoing discussions with the FDA aim to expedite the development, registration, and delivery of Zorevunersen to patients, potentially benefiting patients with Dravet syndrome sooner than expected.
Stoke Therapeutics' updates on enrollment timelines and progress in the EMPEROR study indicate promising advancements in the development of Zorevunersen for Dravet syndrome. The company's commitment to exploring expedited regulatory pathways reflects a dedication to addressing patient needs.