Solid Biosciences Inc. announced positive feedback from a recent Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its SGT-003 gene therapy for Duchenne Muscular Dystrophy. The FDA agreed with the design of the planned Phase 3 randomized, double-blind, placebo-controlled IMPACT DUCHENNE trial, which will enroll ambulant participants aged 7 to under 12 years and use change from baseline in Time to Rise (TTR) velocity from supine position at 18 months as the primary endpoint. The company anticipates dosing the first participant in the Phase 3 trial in the first quarter of 2026. As of February 9, 2026, SGT-003 has been dosed in 36 participants in an ongoing Phase 1/2 trial, with the therapy reported to be generally well tolerated. Solid Biosciences also plans to hold additional FDA meetings in the first half of 2026 to discuss a potential accelerated approval pathway for SGT-003. Results from the planned Phase 3 trial have not yet been presented.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Solid Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9650905-en) on February 09, 2026, and is solely responsible for the information contained therein.