secwatch.observer — SEC 8-K summary
======================================

Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2025-12-05T23:59:59+00:00
Accession:  0001193125-25-308781
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 and Biogen present data supporting zorevunersen's disease-modifying potential for Dravet syndrome
--------------------------------------------------------------------------------

- Propensity score weighted analysis shows statistically significant reductions in major motor seizure frequency at 6 months (70mg loading dose) vs natural history.
- Improvements in cognition and behavior (Vineland-3) at 18 months with 45mg dosing; durable effects through 24 months.
- EEG analysis reveals dose-dependent decrease in abnormal brain activity; reduction in EEG abnormality correlated with seizure reduction.
- Safety: 81 patients, >800 doses; CSF protein elevations in 42% (Phase 1/2a) and 86% (OLE) but no clinical manifestations; 3 unrelated deaths (2 SUDEP, 1 malnutrition).
- Data are consistent with endpoints in ongoing Phase 3 EMPEROR study (week 28 primary, 18-month secondary).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525308781/0001193125-25-308781-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312525308781/d272524d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-308781

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