(RTTNews) - Solid Biosciences Inc. (SLDB) announced that it has received positive regulatory feedback from a recent Type C meeting with the U.S FDA, marking a key step forward for its gene therapy candidate SGT-003 in Duchenne muscular dystrophy.
The FDA agreed with the company's proposed design for IMPACT DUCHENNE, a randomized, double-blind, placebo-controlled Phase 3 trial. The agency confirmed that the planned patient population- ambulant boys aged 7 to under 12 years- and the primary endpoint of change from baseline in Time to Rise (TTR) velocity at 18 months are appropriate for the pivotal study. Key secondary endpoints were also deemed reasonable, giving Solid a clear regulatory path to initiate the trial.
Solid expects to dose the first participant in the first quarter of 2026, with trial sites planned across Australia, Canada, the EU, and the UK. Due to strong interest from clinicians and families, the company is also evaluating the potential to open U.S. sites.
The company noted that SGT-003 continues to show encouraging safety and tolerability in the ongoing Phase 1/2 INSPIRE DUCHENNE trial, where 36 participants have been dosed as of February 9, 2026. The therapy has been generally well tolerated, reinforcing confidence as the program advances into late-stage development.
Solid also plans additional FDA meetings in the first half of 2026 to discuss the confirmatory evidence required to support a potential accelerated approval pathway for SGT-003.
President and CEO Bo Cumbo emphasized the importance of the regulatory progress, stating that alignment on the Phase 3 design represents a "critical first step" in the company's strategy to pursue accelerated approval. He added that the momentum from both regulatory clarity and patient demand strengthens Solid's commitment to bringing new therapeutic options to the Duchenne community.
SLDB has traded between $2.41 and $7.37 over the past year. The stock is currently trading at $6.15, down 5.12%.
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