August 24, 2026 11:17 AM EDT
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Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
Ayisha Sharma
News Reporter
Regenxbio's RGX-121 Hunter syndrome gene therapy faces second clinical hold after spinal lumps found in 5 CAMPSIITE trial patients, sending $RGNX shares down 23%.
August 24, 2026 11:17 AM EDT
R&DFDA+
Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
Ayisha Sharma
News Reporter

Investigators detected masses on the spines of five patients who received its Hunter syndrome treatment, leading to the program’s…

Regenxbio stock drops over 23% following an FDA clinical hold on its Hunter Syndrome gene therapy RGX-121 due to spine MRI…

Regenxbio plans to resubmit its Hunter syndrome gene therapy RGX-121 after the FDA reversed course, saying existing data are…

REGENXBIO Announces Regulatory Update on RGX-121 for MPS II

FDA reverses its rejection of Regenxbio Navsunli, allowing the company to refile its gene therapy application.

The FDA put a hold on a Regenxbio gene therapy trial again after new safety concerns emerged.

REGENXBIO Announces Regulatory Update on RGX-121 for MPS II