---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-076478"
form_type: "8-K"
ticker: "STOK"
cik: "0001623526"
company_name: "Stoke Therapeutics, Inc."
filed_at: "2024-03-25T23:59:59+00:00"
generated_at: "2026-06-04T08:29:47.585254+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Stoke reports STK-001 data: 85% median seizure reduction at 3 months; FDA allows 70mg dosing

## Summary
- Phase 1/2a: 70mg (2-3 doses) showed median 85% reduction in convulsive seizure frequency at 3 months (n=10) and 74% at 6 months (n=9) after last dose.
- OLE studies: durable seizure reductions and clinically meaningful improvements in cognition/behavior (VINELAND-3) over 12 months with continued 30mg or 45mg dosing.
- FDA clearance for three 70mg doses followed by 45mg; company plans to meet with regulators to discuss registrational study design.
- STK-001 generally well-tolerated; 30% (24/81) had treatment-related TEAEs, most commonly CSF protein elevation and procedural vomiting.
- 92% of eligible patients enrolled in OLEs with 84% remaining; data contrast with natural history showing no improvement in seizures or cognition.

## SEC filing metadata
- accession: 0001193125-24-076478
- form_type: 8-K
- ticker: STOK
- cik: 0001623526
- company_name: Stoke Therapeutics, Inc.
- filed_at: 2024-03-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/0001193125-24-076478-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/d816172d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-076478
- JSON: https://secwatch.observer/filing/0001193125-24-076478.json
- Plain text: https://secwatch.observer/filing/0001193125-24-076478.txt

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