In the News
RegenXBio gets FDA support for Hunter syndrome gene therapy’s accelerated review filing—in 2024
It’s going to be a long wait, but RegenXBio is already waving a flag to show that the Hunter syndrome gene therapy RGX-121 is headed for an accelerated approval request at the FDA. The company has been given the go-ahead from the FDA to file its biologics license application for the therapy under the accelerated review pathway, which allows drugs for conditions with an unmet need to reach patients sooner. But in this case, sooner means 2024, which is when RegenXBio plans to officially submit the application.
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