Advancement in Phase I/II AFFINITY DUCHENNE ® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this month BLA submission for RGX-121 initiated and expected to complete in Q1 2025 Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile End-of-Phase II meeting for ABBV-RGX-314 in diabetic retinopathy accelerated to Q4 2024 to support global pivotal program initiation in H1 2025 Conference call today at 4:30 p.m. ET ROCKVILLE, Md.
, Nov. 6, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX ) today reported financial results and recent operational highlights for the third quarter ended September 30, 2024 .
"It has been a turning point year for REGENXBIO, as we are on the cusp of advancing AFFINITY DUCHENNE ® to pivotal phase, completing our first BLA for MPS II and entering pivotal phase in a second indication within our global eyecare collaboration with AbbVie," said Curran M. Simpson , President and Chief Executive Officer of REGENXBIO. "The rapid progress we are making in RGX-202, which continues to demonstrate its potential to be a best-in-class gene therapy for Duchenne, is highly encouraging, and the near-term filing of our BLA for RGX-121 represents a major milestone for the patient community in need of a treatment to address both the neurocognitive and systemic effects of MPS.
