Feb. 9 at 3:00 PM
Solid Biosciences reported positive regulatory progress for its Duchenne muscular dystrophy treatment candidate SGT-003 after reaching agreement with the FDA on the design of its Phase 3 IMPACT DUCHENNE trial. The FDA confirmed that the randomized, double-blind, placebo-controlled study design and patient population parameters are appropriate.
The company plans to dose the first participant in the Phase 3 trial in the first quarter of 2026 and will hold additional FDA meetings in the first half of the year to discuss a potential accelerated approval pathway. Solid also updated its ongoing Phase 1/2 INSPIRE DUCHENNE trial, noting that 36 participants have been dosed to date and that SGT-003 continues to be generally well tolerated.
The Phase 3 trial is currently planned across sites in Australia, Canada, the EU, and the U.K., with potential expansion to the U.S. under evaluation due to strong interest from clinicians and patients.
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