REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
View original at finance.yahoo.comREGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026 Robust patien…
What we drew from this source
The claims Via News extracted from this document. We point to the source; we don't replace it.
All RGX-202 pivotal dose patients exceeded expected disease trajectory on NSAA, improving average of 7.4 points vs cTAP at 18 months
80% confidenceREGENXBIO is rapidly advancing late-stage pipeline with multiple near-term catalysts in 2026, driven by fully in-house capabilities, commercial-ready manufacturing, and global partners
80% confidenceREGENXBIO plans to request pre-BLA meeting in mid-2026 to align with FDA on BLA submission for RGX-202
80% confidenceThousands of patients have been treated with REGENXBIO's AAV platform, including those receiving Zolgensma
80% confidenceCash balance of $240.9M as of December 31, 2025 expected to fund operations into early 2027, excluding potential partner milestone payments and non-dilutive funding
80% confidenceREGENXBIO expects majority of confirmatory trial (n=30) enrolled at time of BLA submission
80% confidenceGlobal regulatory submissions for sura-vec wet AMD are expected in 2027
80% confidenceSura-vec is potentially the first-in-class treatment for wet AMD and diabetic retinopathy
80% confidenceAt two years post-treatment with sura-vec Dose Level 3 in ALTITUDE trial, no intraocular inflammation was observed (n=15), 50% achieved ≥2-step DRSS improvement, and ≥70% risk reduction in vision-threatening complications vs historical controls
80% confidenceREGENXBIO is working to address concerns in RGX-121 CRL with goal of resubmitting BLA
80% confidenceRGX-202 is designed to be a potential best-in-class gene therapy for Duchenne with unique C-Terminal domain inclusion for muscle protection
80% confidence
Cited in these Via News reports
- BDC Dividend Cuts Hit 9% as Global Flight to Safety Pushes Gold Past $5,250 →
- BDC Dividend Cuts Spark 8-9% Selloffs as Global Alternative Investment Stress Intensifies →
- BlackRock TCP, MidCap Cut Dividends as $1.5 Trillion Global Private Credit Market Faces Stress Test →
- Digital Currency Group CEO Projects 5-10% Bitcoin Capital Shift to Privacy Coins Amid Global Surveillance →
- Global Credit Stress: U.S. BDC Dividend Cuts Echo Worldwide Private Lending Concerns →
- Global Private Credit Markets Crack as BDCs Cut Dividends 50% on Middle East Tensions →
- Privacy Crypto Bets on 500x Returns as Global Credit Markets Show Stress →
- U.S. Middle-Market Lenders Cut Dividends as Global Private Credit Faces First Major Stress Test →