---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-272559"
form_type: "8-K"
ticker: "STOK"
cik: "0001623526"
company_name: "Stoke Therapeutics, Inc."
filed_at: "2024-12-06T23:59:59+00:00"
generated_at: "2026-05-29T06:35:39.427395+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Stoke Therapeutics receives FDA Breakthrough Therapy Designation for zorevunersen in Dravet syndrome

## Summary
- FDA granted Breakthrough Therapy Designation for zorevunersen to treat Dravet syndrome with a confirmed SCN1A mutation.
- Phase 1/2a data showed 85% median reduction in convulsive seizure frequency at 3 months post-last dose of 70mg.
- OLE study patients on 45mg maintenance achieved 87% median reduction in seizures at month eight.
- Patients showed continuous improvements in cognition and behavior through 2 years of treatment per Vineland-3.
- Company plans to provide Phase 3 registrational study update by end of 2024.

## SEC filing metadata
- accession: 0001193125-24-272559
- form_type: 8-K
- ticker: STOK
- cik: 0001623526
- company_name: Stoke Therapeutics, Inc.
- filed_at: 2024-12-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/0001193125-24-272559-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/d916273d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-272559
- JSON: https://secwatch.observer/filing/0001193125-24-272559.json
- Plain text: https://secwatch.observer/filing/0001193125-24-272559.txt

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