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May 14, 2025

FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome

Regenxbio has announced the acceptance of its biologics license application (BLA) by the US Food and Drug Administration (FDA) of its gene therapy clemidsogene lanparvovec (RGX-121) for review to potentially treat Mucopolysaccharidosis II (MPS II), also referred as Hunter syndrome.

FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome