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Running on Clouds: The Story of On
The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
Regenxbio
Regenxbio (RGNX) investor relations material
Regenxbio 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
Strategic pipeline and clinical milestones
BLA under review for Hunter program with PDUFA date set for February 8; top-line pivotal data for Duchenne (RGX-202) expected in Q2 2026 and BLA submission mid-2026.
Late-stage wet AMD program with AbbVie to report top-line data late this year; phase II-B/III diabetic retinopathy study to start in first half of the year, with a $100M milestone upon first patient dosing.
RGX-202 pivotal trial fully enrolled ahead of schedule; confirmatory study underway with broad age inclusion and global expansion plans.
Hunter program targets CNS delivery for ultra-rare disease, showing 80% biomarker reduction and neurocognitive stabilization or improvement.
Partnership with Nippon Shinyaku for commercialization of Hunter program, with double-digit royalties and potential for geographic expansion.
Differentiation and technology innovation
Proprietary AAV8 and AAV9-based NAV technology with over 5,000 patients dosed; new capsids in preclinical development for tissue specificity and improved safety.
High-yield, high-purity manufacturing processes enable production of 2,500 RGX-202 doses and 350,000 Surovec doses annually; FDA-inspected facility with no observations.
80% full capsid levels achieved, exceeding FDA guidance and contributing to safety and efficacy.
New capsids for suprachoroidal delivery enable higher transgene expression at lower doses, expanding therapeutic window.
Clinical data and safety profile
RGX-202 phase I/II data show all participants with microdystrophin above 10%, no SAEs or AESIs, and significant functional improvements (NSAA delta 7.4 at 18 months).
Proactive triple immunosuppression regimen (steroids, sirolimus, eculizumab) reduces liver injury and complement activation, allowing higher dosing and improved safety.
Hunter program demonstrates 80% reduction in D2S6 biomarker, with improved or stabilized neurocognitive outcomes in treated patients.
Wet AMD and diabetic retinopathy programs show long-term durability and safety, with subretinal and suprachoroidal administration strategies.
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Next Regenxbio earnings date
Q4 20256 Mar, 2026
Regenxbio
Next Regenxbio earnings date
Q4 20256 Mar, 2026
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Frequently asked questions
REGENXBIO is a clinical-stage biotechnology company that provides gene therapy product candidates to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins or antibodies that are intended to impact disease. Its lead product candidate is RGX-314, which is in Phase III clinical trial for the treatment of wet age-related macular degeneration.
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