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Solid Biosciences (SLDB) investor relations material
Solid Biosciences Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary2 Dec, 2025
Pipeline focus and differentiation
Precision gene therapy platform targets Duchenne muscular dystrophy (DMD), Friedreich's ataxia (FA), CPVT, TNNT2, and other cardiac diseases.
Proprietary capsids, promoters, and dual plasmids are used to improve delivery and manufacturing purity.
SGT-003 is the lead program for DMD, rebuilt with a novel capsid (SLB101) and unique R16, R17 repeat domain.
Early data show promising translation from preclinical to human studies, especially in cardiac function.
Focus on next-generation gene therapy by moving beyond first-generation delivery tools.
Clinical development and regulatory strategy
Dosed 23 DMD patients, aiming for 28-30 by year-end, with a holiday pause before resuming in early 2024.
Three cohorts enrolled: ages 0-3, 4-6, and 7-12, with early safe dosing in very young children.
FDA engagement split into three meetings in early 2024: double-blind placebo control, external control/stat plan, and data requirements for filing.
Plan to use external control data (e.g., C-TAP), with age-matching, pending FDA agreement.
Targeting rolling submission for approval late next year, pending regulatory feedback.
Safety and efficacy insights
No drug-induced liver injury observed; one mild grade 3 myositis case led to exclusion of a rare mutation.
Robust expression data in DMD, with updates planned; unique capsid shows rapid clearance from blood, potentially reducing adverse events.
Key learnings from outlier patients led to dosing modifications and method-of-use patent filings.
Dosing modifications implemented in all relevant programs, with steroids as the only adjunct therapy.
Safety and biomarker updates to be shared at upcoming conferences.
SGT-003: Strategy for 0-3 year old label?
SLB101: How does rapid clearance impact safety?
FA program: Unique multi-organ targeting strategy?
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Next Solid Biosciences earnings date
Q4 20256 Mar, 2026
Next Solid Biosciences earnings date
Q4 20256 Mar, 2026
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Frequently asked questions
Solid Biosciences Inc. is a life science company dedicated to developing therapies for neuromuscular and cardiac diseases. The company's primary focus includes advancing a portfolio of gene therapy candidates for various conditions, such as Duchenne muscular dystrophy with its lead product candidate SGT-003, Friedreich's ataxia treated by AVB-202-TT, and BAG3-mediated dilated cardiomyopathy with AVB-401. Solid Biosciences is also working on developing platform technologies that include dual gene expression, allowing for the packaging of multiple transgenes into one vector, and the exploration of novel capsids. The company's mission is driven by a commitment to improve the daily lives of patients living with these debilitating diseases, supported by collaborations and partnerships, including a notable agreement with Ultragenyx Pharmaceutical Inc. for the development and commercialization of new gene therapies for Duchenne muscular dystrophy. The company is headquartered in Charlestown, Massachusetts, and its shares are listed on the Nasdaq.
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