---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-070652"
form_type: "8-K"
ticker: "STOK"
cik: "0001623526"
company_name: "Stoke Therapeutics, Inc."
filed_at: "2023-03-15T23:59:59+00:00"
generated_at: "2026-06-18T02:03:44.500828+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA allows Stoke to administer higher 70mg single dose of STK-001 in Dravet syndrome study

## Summary
- FDA permits 70mg single dose cohort in Phase 1/2a MONARCH study; dosing expected in coming weeks.
- MONARCH remains on partial clinical hold for multiple doses above 45mg; ADMIRAL study continues multiple 70mg dosing.
- Data from multiple 45mg doses anticipated mid-2023; data from 70mg (single/multiple) expected H2 2023.
- Company on track to complete Phase 1/2a studies in 2023 and initiate Phase 3 program in 2024.

## SEC filing metadata
- accession: 0001193125-23-070652
- form_type: 8-K
- ticker: STOK
- cik: 0001623526
- company_name: Stoke Therapeutics, Inc.
- filed_at: 2023-03-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1623526/000119312523070652/0001193125-23-070652-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1623526/000119312523070652/d452341d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-070652
- JSON: https://secwatch.observer/filing/0001193125-23-070652.json
- Plain text: https://secwatch.observer/filing/0001193125-23-070652.txt

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