secwatch.observer — SEC 8-K summary
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Issuer:     Edgewise Therapeutics, Inc. (EWTX)
CIK:        0001710072
Form:       8-K
Filed at:   2021-10-28T23:59:59+00:00
Accession:  0001157523-21-001266
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Edgewise reports positive Phase 1 MAD results for EDG-5506; Phase 2 in BMD and DMD planned for 2022
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- EDG-5506 generally well tolerated; no serious adverse events; mild dizziness/somnolence resolved.
- PK data showed muscle concentrations well above efficacious levels from preclinical DMD models.
- PD demonstrated dose-proportional inhibition of involuntary twitch without affecting voluntary strength or cardiac myosin.
- Phase 1b dosing of BMD patients initiated; Phase 2 in BMD expected Q1 2022, DMD H2 2022.
- Follow-on open-label study in BMD planned for Q1 2022 to assess biomarkers over 3 months.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710072/000115752321001266/0001157523-21-001266-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710072/000115752321001266/a52517172.htm
  HTML page:      https://secwatch.observer/filing/0001157523-21-001266

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