Regenxbio plans to resubmit its Hunter syndrome gene therapy RGX-121 after the FDA reversed course, saying existing data are sufficient for accelerated approval review.
Curran Simpson, Regenxbio CEO (Brian Benton Photography)
June 22, 2026 07:14 AM EDT
PharmaFDA+
Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues
Lei Lei Wu
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