secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2025-01-07T23:59:59+00:00
Accession:  0001193125-25-002550
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/0001193125-25-002550-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/d915192d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-002550

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