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February 10, 2026

REGENXBIO receives FDA response for RGX-121 application

REGENXBIO has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) related to its biologics licence application (BLA) for RGX-121 (clemidsogene lanparvovec) to treat mucopolysaccharidosis II (MPS II), also called Hunter syndrome.

REGENXBIO receives FDA response for RGX-121 application