secwatch.observer — SEC 8-K summary
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Issuer:     Stoke Therapeutics, Inc. (STOK)
CIK:        0001623526
Form:       8-K
Filed at:   2024-12-06T23:59:59+00:00
Accession:  0001193125-24-272559
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Stoke Therapeutics receives FDA Breakthrough Therapy Designation for zorevunersen in Dravet syndrome
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- FDA granted Breakthrough Therapy Designation for zorevunersen to treat Dravet syndrome with a confirmed SCN1A mutation.
- Phase 1/2a data showed 85% median reduction in convulsive seizure frequency at 3 months post-last dose of 70mg.
- OLE study patients on 45mg maintenance achieved 87% median reduction in seizures at month eight.
- Patients showed continuous improvements in cognition and behavior through 2 years of treatment per Vineland-3.
- Company plans to provide Phase 3 registrational study update by end of 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/0001193125-24-272559-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/d916273d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-272559

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