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Solid Biosciences
Solid Biosciences (SLDB) investor relations material
Solid Biosciences 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary14 Jan, 2026
Key pipeline and clinical milestones
Dosed 33 patients in phase 1/2 Duchenne trial; no drug-induced liver injury, myocarditis, or aHUS observed.
First patient dosed in Friedreich's ataxia (FA) with dual-route administration; MRI-guided delivery confirmed and patient doing well.
Double-blind placebo-controlled Duchenne trial fully enrolled; global sites opening, aiming for 18-month enrollment and ex-US Phase 3 expansion.
CPVT trial to begin dosing this quarter; first participant expected in Phase 1b ARTEMIS trial in Q1 2026.
Over 50 partnerships and agreements established for next-generation capsid platform.
Clinical data and safety profile
Microdystrophin mean expression at 58% (highest in field) at lowest viral dose; robust biomarker improvements and DAPC restoration observed.
No drug-induced liver injury, TMA, aHUS, or myocarditis in 33 patients; safety profile improving with dosing modifications.
Troponin levels declined by 70%, ejection fraction increased in low/low-normal patients, and muscle integrity biomarkers improved.
Embryonic myosin heavy chain declined by 49%, indicating muscle repair; negative correlation with microdystrophin.
SGT-003 well tolerated in 33 participants aged 1–10 years; most common adverse events were vomiting, nausea, and thrombocytopenia.
Regulatory and commercial strategy
Three FDA meetings planned by midyear: phase 3 trial, external control/stat plan, and accelerated approval pathway.
UK Innovation Passport (ILAP) received; may expedite approval and reimbursement, aiming to be first gene therapy to market in UK.
Integrated US and ex-US pivotal trial strategy underway, with Phase 1/2 and Phase 3 trials active and enrolling.
Double-blind placebo-controlled trial to serve as confirmatory study for US and full approval ex-US.
Vast majority of eligible Duchenne patients remain untreated, with a potential $28B+ market opportunity in US and EU.
How does unsnooped data aid SGT-003 approval?
What is the FA trial strategy given first patient?
How do next-gen capsids impact gene therapy future?
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Next Solid Biosciences earnings date
Q4 20256 Mar, 2026
Solid Biosciences
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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