Clinical Trial SuccessPositive data in NPDR warrant a pivotal trial, with significant improvements in the Phase 2 ALTITUDE trial of sura-vec gene therapy.
Manufacturing CapabilitiesRGNX’s modernized, scalable, and reproducible manufacturing capacity was confirmed by FDA inspections with no observations or issues, which is relatively unprecedented in the gene therapy space.
Regulatory SupportRGX-121 has received multiple designations from the FDA, including Orphan Drug and Fast Track, indicating strong regulatory support.