RegenxBio Announced Completion of a Successful Pre-BLA Meeting with the FDA for RGX-121 for Mucopolysaccharidosis Type II
June 18, 2024
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RegenxBio Today RegenxBio (RGNX) announced it completed a successful Pre-Biologics License Application (BLA) meeting with the FDA for the RGX-121 treatment of Mucopolysaccharidosis Type II (MPS II). The FDA continues to be aligned with RegenxBio's plan to use cerebrospinal fluid (CSF) levels of heparan sulfate (HS) D2S6, a key biomarker of brain disease activity, as a . . . This content is for paid subscribers. …