Regenxbio Shares Fall After FDA Declines Approval of Hunter Syndrome Treatment
By Rob Curran
Shares of Regenxbio fell sharply premarket after the Food and Drug Administration rejected the biotech company's initial application for commercialization of a gene therapy for rare disease Hunter syndrome.
The Rockville, Md., biotechnology company said late Monday that the FDA did not agree the data set provided in its application provided substantial evidence that the therapy RGX-121 was effective in the treatment of the often terminal genetic condition. There is no cure for Hunter Syndrome, which affects the body's ability to dispose of certain waste.
Regenxbio said it plans to find a path forward as quickly as possible with the goal of resubmitting its biologics license application.
Shares of the biotech company fell 9.2% to $9.36 premarket.
Write to Rob Curran at rob.curran@dowjones.com
(END) Dow Jones Newswires
February 10, 2026 07:11 ET (12:11 GMT)
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