secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2024-01-08T23:59:59+00:00
Accession:  0001193125-24-003939
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Stoke Therapeutics details 2024 clinical milestones; STK-001 data in Q1, STK-002 trial in UK
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- In Q1 2024, plans to report safety, PK, and CSF results from 81 patients in STK-001 Phase 1/2a and OLE studies.
- Seizure frequency data from ~20 patients who received 1-3 doses of 70mg STK-001, followed for six months, will be released in Q1.
- Repeat dose effects (30mg, 45mg) on seizure frequency and cognition/behavior from OLE studies also expected in Q1.
- Depending on Q1 results, plans to start Phase 3 preparation including regulatory discussions and toxicology data.
- Phase 1 study of STK-002 for Autosomal Dominant Optic Atrophy expected to begin in UK in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524003939/0001193125-24-003939-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524003939/d39993d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-003939

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