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Regenxbio (RGNX) investor relations material
Regenxbio Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary10 Nov, 2025
Key program updates
Late-stage assets are approaching major milestones, including a BLA review for the Hunter program with a PDUFA date in February and pivotal data for the Duchenne program expected in Q2 next year.
Wet AMD program (RGX-314) completed enrollment in two of the largest gene therapy trials, with top-line data expected by end of 2026.
RGX-314 aims to reduce treatment burden in wet AMD by offering a one-time gene therapy, potentially improving compliance and vision outcomes compared to frequent anti-VEGF injections.
Partnership with AbbVie for RGX-314 includes a 50/50 profit share, with AbbVie leading commercialization.
Manufacturing investments have led to high yields and cost of goods more in line with biologics.
Differentiation and innovation
RGX-314 uses subretinal delivery, an immune-privileged and clinically validated route, reducing inflammation and off-target effects compared to intravitreal approaches.
The Duchenne construct includes the C terminal domain, improving efficacy and half-life, and features high product purity for optimal dosing.
Unique immunosuppression regimen in Duchenne program (eculizumab and serolimus) has resulted in no thrombocytopenia or liver injury in treated patients.
NSAA data in older Duchenne patients show unexpected functional improvements, attributed to construct design and dosing.
Regulatory and commercial outlook
Consistent FDA engagement for all programs, with next Duchenne meeting planned for first half of next year and Hunter BLA review ongoing.
Hunter program’s PDUFA date moved to February after a major amendment; FDA confirmed no further data requests beyond minor queries.
One-year data for Hunter program presented at ICIEM showed strong biomarker correlation and positive neurocognitive outcomes.
Manufacturing and clinical inspections for Hunter program completed with no observations, de-risking regulatory pathway.
Hunter program eligible for a PRV if approved before September 2026, which would be owned and potentially monetized.
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Stifel 2025 Healthcare Conference11 Nov, 2025
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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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