secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2026-01-12T23:59:59+00:00
Accession:  0001193125-26-009781
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Stoke Therapeutics accelerates EMPEROR enrollment, expects Phase 3 data in mid-2027, cash $391.7M
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- Enrollment of 150 patients in Phase 3 EMPEROR study expected to complete in Q2 2026, accelerated from prior timeline.
- Phase 3 data readout planned for mid-2027; rolling NDA submission to initiate in first half 2027.
- FDA multidisciplinary meeting held; no immediate program changes, but discussions ongoing for expedited pathways.
- Cash, equivalents and marketable securities $391.7M as of Dec 31, 2025; plus Biogen proceeds funds operations into 2028.
- Nearly 330 potential study candidates identified globally; ~60 in screening, ~60 randomized/dosed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312526009781/0001193125-26-009781-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312526009781/d36198d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-009781

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