---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-002550"
form_type: "8-K"
ticker: "STOK"
cik: "0001623526"
company_name: "Stoke Therapeutics, Inc."
filed_at: "2025-01-07T23:59:59+00:00"
generated_at: "2026-05-28T08:31:05.572053+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Stoke announces global regulatory alignment for Phase 3 study of zorevunersen in Dravet syndrome

## Summary
- Aligned with FDA, EMA, and PMDA for Phase 3 EMPEROR; study to start mid-2025, data by end of 2027.
- Primary endpoint: reduction in major motor seizure frequency; key secondary: cognition and behavior via Vineland-3.
- Dosing: two 70mg loading doses then two 45mg maintenance doses over 52 weeks; ages 2 to <18.
- Commercial opportunity: >38,000 patients with Dravet syndrome in seven major markets.
- FDA Breakthrough Therapy designation; prior OLE data: 87% median seizure reduction at month 8.

## SEC filing metadata
- accession: 0001193125-25-002550
- form_type: 8-K
- ticker: STOK
- cik: 0001623526
- company_name: Stoke Therapeutics, Inc.
- filed_at: 2025-01-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/0001193125-25-002550-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/d915192d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-002550
- JSON: https://secwatch.observer/filing/0001193125-25-002550.json
- Plain text: https://secwatch.observer/filing/0001193125-25-002550.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.