secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2023-03-15T23:59:59+00:00
Accession:  0001193125-23-070652
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA allows Stoke to administer higher 70mg single dose of STK-001 in Dravet syndrome study
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- FDA permits 70mg single dose cohort in Phase 1/2a MONARCH study; dosing expected in coming weeks.
- MONARCH remains on partial clinical hold for multiple doses above 45mg; ADMIRAL study continues multiple 70mg dosing.
- Data from multiple 45mg doses anticipated mid-2023; data from 70mg (single/multiple) expected H2 2023.
- Company on track to complete Phase 1/2a studies in 2023 and initiate Phase 3 program in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312523070652/0001193125-23-070652-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312523070652/d452341d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-070652

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