secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2026-06-30T12:02:16+00:00
Accession:  0001193125-26-289409
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Stoke completes enrollment of 162 patients in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome
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- Completed enrollment of 162 patients in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
- Plans to initiate rolling NDA submission to FDA in Q1 2027; data readout anticipated in Q3 2027.
- Approximately 50 of 162 patients have passed 28-week primary endpoint measurement; no discontinuations.
- Additional cohort of ~30 patients enrolling in Europe; last patient expected in August.
- Potential FDA approval and U.S. launch by early 2028.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312526289409/0001193125-26-289409-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312526289409/d924679d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-289409

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