Core Insights - Solid Biosciences is advancing its gene therapy programs for neuromuscular and cardiac diseases, with significant progress reported in multiple clinical trials as of January 2026 [1][2][3] Neuromuscular Pipeline - SGT-003 for Duchenne muscular dystrophy has been well tolerated in 33 participants dosed in the Phase 1/2 INSPIRE DUCHENNE trial, with no serious adverse events reported as of January 9, 2026 [3][4] - The company plans to engage with the FDA in the first half of 2026 to discuss the design of a Phase 3 confirmatory trial for SGT-003, aiming for potential accelerated approval [3][4] - The first participant has been enrolled in the Phase 3 IMPACT DUCHENNE trial, with dosing expected in Q1 2026 [1][7] - SGT-212 for Friedreich's ataxia has received FDA Orphan Drug designation and the first participant has been dosed in the Phase 1b FALCON trial, which is the first gene therapy for FA utilizing a dual route of administration [1][7] Cardiac Pipeline - SGT-501 is being evaluated in the ARTEMIS Phase 1b trial for catecholaminergic polymorphic ventricular tachycardia, with participant screening currently underway [1][7] - Initial safety data from the ARTEMIS trial is expected in the second half of 2026 [7] Platform Technologies - Solid Biosciences has executed over 50 agreements for the use of its proprietary next-generation capsid AAV-SLB101, which aims to enhance gene therapy delivery [1][5][7] - AAV-SLB101 has shown promising results in terms of safety and efficacy in the ongoing trials [7]
Solid Biosciences Provides 2026 Outlook Underscoring Neuromuscular and Cardiac Pipeline Momentum and Expanded Access to Next-Generation Capsid AAV-SLB101