Stoke Therapeutics Completes Enrollment for Phase 3 Dravet Syndrome Study, Sets NDA & Data Readout Timelines
STOK has more than doubled off its 52-week low of $11.19.
Summary
Stoke Therapeutics has completed enrollment for its Phase 3 EMPEROR study of zorevunersen for Dravet syndrome, with a Phase 3 data readout expected in Q3 2027 and a rolling NDA submission to begin in Q1 2027.
Key Events · Product Development and Regulatory · STOK
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Completion of Phase 3 Enrollment
Stoke Therapeutics announced the completion of enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
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Anticipated Data Readout
Phase 3 data readout from the primary analysis population is expected in the third quarter of 2027.
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Rolling NDA Submission Plan
The company plans to initiate a rolling New Drug Application (NDA) submission to the U.S. FDA in the first quarter of 2027, with completion anticipated in the second half of 2027.
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No Patient Discontinuations
No patients have discontinued treatment in the study, suggesting good tolerability and safety so far.
Analysis · STOK · Life Sciences
This 8-K announces a significant de-risking event for Stoke Therapeutics, marking the completion of enrollment for its pivotal Phase 3 EMPEROR study of zorevunersen for Dravet syndrome. This milestone brings the company closer to potential market entry for its lead investigational medicine, which has Breakthrough Therapy Designation. The outlined timelines for a rolling NDA submission starting Q1 2027 and a Phase 3 data readout in Q3 2027 provide a clear path to potential commercialization by early 2028.
At the time of this filing, STOK was trading at $32.39 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2B. The 52-week trading range was $11.19 to $40.22. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.