REGENXBIO Inc.(RGNX)Earnings, Financials & Key Ratios

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery.

REGENXBIO upgraded to 'Strong Buy' on FDA's course reversal for rare disease therapies, notably impacting NAVSUNLI [RGX-121] for MPS II. Company expects to resubmit NAVSUNLI BLA in Q3 2026, leveraging robust CAMPSIITE trial data and no new study requirements per FDA alignment. RGX-202 for DMD and sura-vec for wet AMD offer additional catalysts, with pivotal trial data and regulatory submissions anticipated through 2027.

Confirmatory study completed ahead of schedule due to strong patient demand and robust investigator interest On track to initiate BLA in Q3 2026 under the accelerated approval pathway supporting potential approval in 2H 2027 ROCKVILLE, Md., June 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy.

RGNX shares jump after FDA alignment on next steps for Navsunli, paving the way for a planned MPS II BLA resubmission in Q3 2026.

Regenxbio Inc. (NASDAQ:RGNX) on Monday said it aligned with the Food and Drug Administration (FDA) regarding the next steps needed for a potential accelerated approval of Navsunli (RGX-121, clemidsogene lanparvovec).