other material
confidence high
sentiment positive
materiality 0.85
Solid Biosciences reports positive interim SGT-003 data; microdystrophin expression 60% at Day 90, 91% at Day 360
Solid Biosciences Inc.
- 40 participants dosed; SGT-003 well tolerated with steroid-only immunomodulation regimen.
- Day 90 biopsy (n=20): mean microdystrophin expression 60% (western blot), 63% positive fibers; 60% beta-sarcoglycan restoration.
- Day 360 biopsy (n=3): microdystrophin expression 91% (western blot), 69% positive fibers; 69% beta-sarcoglycan restoration.
- Biomarker improvements: CK -38%, ALT -43%, AST -30%, LDH -46%, eMHC -44% at Day 90.
- FDA aligned on Phase 3 design; screening underway; first participant dosing expected Q1 2026; accelerated approval discussions planned.