Solid Bio Positive Feedback from Type C with FDA for SGT-003 Gene Therapy for Duchenne

 - 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 -

https://www.globenewswire.com/news-release/2026/02/09/3234485/0/en/Solid-Biosciences-Announces-Positive-Feedback-from-Type-C-Meeting-with-FDA-for-SGT-003-Gene-Therapy-for-Duchenne-Muscular-Dystrophy.html