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ROCKVILLE, Md. , July 25, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, August 1, 2024 , at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2024 , and recent operational highlights.

Company to begin enrollment of  patients aged 1-3 years Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal  program design Based on recent commercial landscape, confirmed

Aligned with FDA on content of BLA and plans for submission: Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024 Confirmatory trial expected to begin in H2 2025 FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material Positive

Jahannaz Dastgir, DO, Sr Clinical Development Lead

Aravindhan Veerapandiyan, MD, Arkansas Children's Hospital

Paul Harmatz, M.D., UCSF Benioff Children's Hospital