REGENXBIO, Inc. Stock News

REGENXBIO Inc. (NASDAQ:RGNX ) Q2 2025 Earnings Call August 7, 2025 8:00 AM ET Company Participants Curran M. Simpson - President, CEO & Director Mitchell Chan - Executive VP & CFO Patrick J.

RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026 Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidance Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; FDA inspections completed successfully Pre-license inspection (PLI) of in-house manufac...

A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE ® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene lomparvovec in subjects with non-proliferative diabetic retinopathy REGENXBIO to receive $100 million upon first...

ROCKVILLE, Md. , July 31, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, August 7, at 8:00 a.m.

Construct including CT domain demonstrated higher levels of microdystrophin protein, increased muscle force, and improved resistance to damage in mice lacking dystrophin REGENXBIO's next-generation investigational gene therapy, RGX-202, is the only microdystrophin construct that includes the CT domain Findings support the positive functional data seen in Phase I/II AFFINITY DUCHENNE® trial of R...

REGENXBIO specializes in gene therapies using proven AAV technology. RGX-121, targets Hunter syndrome and is under FDA review, with a PDUFA date set for November 9, 2025. We believe the upcoming FDA decision represents a significant catalyst for RGNX shares, offering a compelling pre-approval investment opportunity.

RGX-202 demonstrating consistent evidence of positively changing disease trajectory for Duchenne All dose level 2 participants exceeded external natural history controls on all functional measures Biomarker data demonstrate consistent, robust microdystrophin expression and transduction levels across all treated ages One new participant aged 2 years at dosing had expression level at 118.6% compa...

Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial ROCKVILLE, Md.