Solid Biosciences Announces Positive Regulatory Update From Type C Meeting With FDA Supporting Continued Advancement Of SGT-003 As 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 -

CHARLESTOWN, Mass., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) (the "Company" or "Solid"), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today 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.

Solid reached alignment with the FDA on the overall study design for the Company's randomized, double-blind, placebo-controlled Phase 3 clinical trial, IMPACT DUCHENNE. 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.