Solid Biosciences announced a positive regulatory update from its recent Type C meeting with the U.S. Food and Drug Administration (FDA) that supports the continued advancement of SGT-003 as a potential treatment for Duchenne muscular dystrophy.
- IMPACT DUCHENNE: Company aligned with FDA on Phase 3 randomized, double-blind, placebo-controlled trial design –
- IMPACT DUCHENNE: Company anticipates first participant dosing in Q1 2026 –
- Company plans for additional meetings with the FDA in 1H 2026 to align on a potential accelerated approval pathway for SGT-003 –
- INSPIRE DUCHENNE: SGT-003 continues to be generally well tolerated with 36 participants dosed as of February 9, 2026, in Phase 1/2 trial –
The FDA agreed that the trial design was reasonable including: the patient population of ambulant participants 7 to <12 years of age, the primary endpoint of change from baseline in Time to Rise (TTR) velocity from supine position evaluated at 18 months and other key secondary endpoints.
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