REGENXBIO: FDA Grants Fast Track Designation For RGX-202

(RTTNews) - REGENXBIO Inc. (RGNX) announced the FDA has granted Fast Track designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy. RGX-202 has been granted Fast Track, Orphan Drug and Rare Pediatric Disease designations by the FDA.

In January, the company announced that the Phase I/II AFFINITY DUCHENNE trial of RGX-202 for the treatment of Duchenne is now active and recruiting patients. Also, REGENXBIO is recruiting patients in the AFFINITY BEYOND trial, an observational screening study to evaluate the prevalence of AAV8 antibodies in patients with Duchenne up to 12 years of age.

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