Stoke Therapeutics, Inc. STOK
Stoke Therapeutics, Inc. (Nasdaq: STOK) is a CNS/neurology/psychiatry drug developer. Its lead program, zorevunersen (STK-001), is in Phase 3 for Dravet syndrome. Its next catalyst on record is STK-002: Completion of cohort 3 dosing (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: STK-002 — Completion of cohort 3 dosing (2026). 6 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| zorevunersen (STK-001) | Dravet syndrome | RNA (siRNA/ASO/mRNA) | Phase 3 |
| STK-002 | Autosomal dominant optic atrophy (ADOA) | RNA (siRNA/ASO/mRNA) | Phase 1 |
| SYNGAP1 program | SYNGAP1-related neurodevelopmental disorder | RNA (siRNA/ASO/mRNA) | Pre-clinical |
Recent results and decisions
- Oct 29, 2026n/a Stoke met with FDA to align on U.S. NDA submission for zorevunersen using multicomponent Vineland-3 assessment for cognition and behavior.
For the NDA, Stoke plans to use a multicomponent assessment of four prespecified Vineland-3 subdomains to evaluate changes in cognition and behavior in the Phase 3 EMPEROR study.
Filing - Oct 29, 2026n/a Initial safety and efficacy data from Phase 1 OSPREY study of STK-002 for ADOA anticipated in first half 2027.
Safety and efficacy data are anticipated in the first half of 2027.
Filing - Jun 30, 2026completed enrollment Phase 3 EMPEROR completed enrollment of 162 patients in the U.S., UK and Japan (about 50 through Week 28); no discontinuations; a ~30-patient European cohort still enrolling.
The Company today announced the completion of enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.