RGNX

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.

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.

FDA confirmed no additional studies required, existing longer-term data from the CAMPSIITE ® study will be reviewed on an expedited basis for approval via the accelerated approval pathway The Company expects to resubmit the BLA in Q3 2026 ROCKVILLE, Md., June 22, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it has aligned with the U.S. Food and Drug Administration (FDA) regarding the next steps needed for a potential accelerated approval of NAVSUNLI™ (clemidsogene lanparvovec-sngl, RGX-121), the only potential one-time treatment and gene therapy for Mucopolysaccharidosis II (MPS II), an ultra-rare neurodegenerative disease also known as Hunter syndrome.

The ​U.S. Food ‌and Drug ​Administration ​will reverse ⁠its ​earlier ​rejection of a ​rare-disease ​therapy from Regenxbio , ‌the ⁠Wall Street ​Journal ​reported ⁠on Monday.

The company plans to refile its application for its gene therapy for a fatal brain disease after the FDA dropped demands to give a placebo to some study subjects.

REGENXBIO Inc. (RGNX) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript

ROCKVILLE, Md., May 18, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences: 2026 RBC Capital Markets Global Healthcare Conference Fireside Chat: Wednesday, May 20 at 9:30am ET Location: New York, NY Stifel 2026 Virtual Ophthalmology Forum Fireside Chat: Tuesday, May 26 at 9:30am ET Location: Virtual Live webcasts of select events can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com.

Regenxbio (RGNX) came out with a quarterly loss of $1.72 per share versus the Zacks Consensus Estimate of a loss of $1.36. This compares to earnings of $0.12 per share a year ago.

Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA, n=9), supporting validity of surrogate endpoint Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track toward key catalysts Sites activated in pivotal Phase IIb/III study for diabetic retinopathy; first patient dosed expected Q2 2026 Subretinal wet AMD topline pivotal data expected in Q4 2026 Clinical hold lifted for RGX-121 Webcast today at 8:00 a.m. ET to discuss RGX-202 topline pivotal data and Q1 2026 earnings ROCKVILLE, Md.