secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2025-08-11T23:59:59+00:00
Accession:  0001193125-25-177433
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

First patient dosed in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome by Stoke and Biogen
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- First patient dosed in global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
- Randomized 1:1 vs sham over 52 weeks; primary endpoint: change in major motor seizure frequency at Week 28.
- Zorevunersen is an investigational antisense oligonucleotide; potential first disease-modifying treatment for Dravet syndrome.
- Key secondary endpoints include cognition/behavior via Vineland-3 subdomains at Week 52.
- Enrollment: ages 2-18 with SCN1A mutation; open-label extension offered to eligible participants.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525177433/0001193125-25-177433-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525177433/d64221d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-177433

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer