Solid Biosciences Announces Positive Feedback from Type C Meeting with FDA for SGT-003 Gene Therapy 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 ...