Solid Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
View original at globenewswire.comSolid Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates - Duchenne (SGT-003): Positive interim Phase 1/2 INSPIRE DUCHENNE data reported at the 2026 MDA Annual Meeting continued to suggest differentiated clinical, safety and tolerability profiles; SGT-003 has been gene…
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INSPIRE DUCHENNE interim data provided continuing evidence suggesting a disease-relevant treatment effect with robust microdystrophin expression, DAPC restoration, muscle integrity biomarker improvements, and cardiac function stabilization
60% confidenceAdditional meetings with FDA planned in H1 2026 for guidance on potential accelerated approval pathway for SGT-003
60% confidenceInitial data from FALCON trial expected in second half of 2026, subject to participant enrollment
60% confidenceSGT-003 could be a potential best-in-class investigational gene therapy for treatment of Duchenne based on design features including R16/17 domains and POLARIS-101 capsid
60% confidenceWe continue to build momentum across our portfolio, highlighted by updated interim INSPIRE DUCHENNE data presented at MDA, positive feedback from FDA Type C meeting on Phase 3 IMPACT DUCHENNE trial design, dosing of first participant in FALCON trial and completion of oversubscribed $240 million private placement
60% confidenceNet proceeds from private placement will be used to fund ongoing pipeline development programs, business development activities, working capital and general corporate purposes
60% confidenceFirst participant in ARTEMIS trial expected to be dosed in Q2 2026, with initial safety data anticipated in second half of 2026
60% confidenceSGT-212 was well tolerated with no treatment-related adverse events as of March 18, 2026
60% confidenceCompany's cash runway anticipated to extend into H1 2028 including net proceeds from $240 million private placement
60% confidenceCompany anticipates dosing first participant in Phase 3 IMPACT DUCHENNE trial in April 2026
60% confidenceSGT-003 continued to be generally well tolerated in 41 participants dosed as of March 18, 2026
60% confidence2026 will be a transformational year for Solid with multiple anticipated regulatory and clinical milestones
60% confidence