RGX-202 Improves 7.4 NSAA Points, Pivotal Data Due Early Q2
RGX-202’s 18-month Phase I/II data show a 7.4-point NSAA improvement versus cTAP, with pivotal topline results due early Q2 2026 and confirmatory enrollment nearly full. The AbbVie-partnered surabgene lomparvovec trial will unlock a $100 million milestone on first dosing in Q2 2026 and wet AMD data are due in Q4 2026.
1. RGX-202 Phase I/II Data and Pivotal Timeline
RGX-202’s Phase I/II data showed an average 7.4-point improvement on the North Star Ambulatory Assessment versus the cTAP disease model at 18 months, demonstrating durability and functional gains. Pivotal topline results from the AFFINITY DUCHENNE trial are expected early Q2 2026, with confirmatory enrollment in its 30-patient study nearly complete.
2. Surabgene lomparvovec Trial Progress and Milestones
Surabgene lomparvovec (ABBV-RGX-314) is advancing the Phase IIb/III NAAVIGATE trial in diabetic retinopathy, triggering a $100 million milestone upon first dosing in Q2 2026. Topline pivotal data for wet AMD from the ATMOSPHERE and ASCENT trials are slated for Q4 2026, paving the way for 2027 global submissions.
3. Pre-BLA Planning and Manufacturing Capabilities
REGENXBIO plans a mid-2026 pre-BLA meeting to align on RGX-202’s BLA submission and has scheduled FDA and EMA interactions in the first half of 2026. The company continues to manufacture RGX-202 for commercial supply at its in-house Manufacturing Innovation Center, supporting launch readiness.