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

Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2024-03-25T23:59:59+00:00
Accession:  0001193125-24-076478
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Stoke reports STK-001 data: 85% median seizure reduction at 3 months; FDA allows 70mg dosing
--------------------------------------------------------------------------------

- Phase 1/2a: 70mg (2-3 doses) showed median 85% reduction in convulsive seizure frequency at 3 months (n=10) and 74% at 6 months (n=9) after last dose.
- OLE studies: durable seizure reductions and clinically meaningful improvements in cognition/behavior (VINELAND-3) over 12 months with continued 30mg or 45mg dosing.
- FDA clearance for three 70mg doses followed by 45mg; company plans to meet with regulators to discuss registrational study design.
- STK-001 generally well-tolerated; 30% (24/81) had treatment-related TEAEs, most commonly CSF protein elevation and procedural vomiting.
- 92% of eligible patients enrolled in OLEs with 84% remaining; data contrast with natural history showing no improvement in seizures or cognition.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/0001193125-24-076478-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/d816172d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-076478

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