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Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

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In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy

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Regenxbio's RGX-202 Duchenne Gene Therapy Shows Positive Interim Data, Pivotal Results Expected Q2 2026 for FDA Accelerated Approval

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FDA Grants Accelerated Approval to Denali's Avlayah for Hunter Syndrome, Defying Rare Disease Rejection Trend

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REGENXBIO Reports Positive Interim Data from Phase I/II AFFINITY DUCHENNE Trial of RGX-202 for Duchenne Muscular Dystrophy

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REGENXBIO's Hunter Syndrome Gene Therapy RGX-121 Rejected by FDA

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FDA Action Alert: Upcoming Decisions on Sanofi/Regeneron, Merck, REGENXBIO and More in February 2026

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FDA Places Clinical Holds on Regenxbio's RGX-111 and RGX-121 Gene Therapy Trials After Brain Tumor in Patient

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