Author name: Leonardo Arias

REGENXBIO’s Hunter syndrome gene therapy hit by FDA hold, stymieing resubmission plans

The FDA has placed a clinical hold on RGX-121 after small nodules or cystic masses were detected in the spines of five patients enrolled in REGENXBIO’s registrational trial. The biotech no longer plans to resubmit the candidate—which was rejected in February—in the near term.

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