Stoke Therapeutics Reports Q2 Results, Sets Path to NDA for Dravet Drug
STOK has more than doubled off its 52-week low of $12.405.
Summary
Stoke Therapeutics reported Q2 2026 financial results and provided a detailed update on its lead program, zorevunersen for Dravet syndrome. The company plans a pre-NDA meeting with the FDA in H2 2026 and expects to initiate a rolling NDA submission in Q1 2027, with completion in H2 2027. Phase 3 EMPEROR study enrollment is complete at 162 patients, with no treatment discontinuations and key milestones approaching—the first patients reach Week 52 in August 2026. Cash position of approximately $420 million is expected to fund operations through a potential U.S. launch by early 2028. The pipeline also includes STK-002 for ADOA, with Phase 1 data anticipated in H1 2027. This follows the June 2026 enrollment completion and builds on the Q1 2026 financial downturn, showing a clear regulatory path and strong execution. The pre-NDA meeting and rolling submission timeline de-risk the program and could position zorevunersen as the first disease-modifying therapy for Dravet syndrome.
At the time of this announcement, STOK was trading at $29.56 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.8B. The 52-week trading range was $12.41 to $40.22. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.