FDA places clinical hold on Regenxbio's RGX-121 gene therapy for Hunter Syndrome
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REGENXBIO Announces Regulatory Update on RGX-121 for MPS II
August 24, 2026 7:05 AM EDTROCKVILLE, Md., Aug. 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today provided an update on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec), for the treatment of Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome. The U.S. Food and Drug Administration (FDA) placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five... More
