
REGENXBIO Announces FDA Acceptance and Priority Review of the BLA for RGX-121 for MPS II
FDA assigns PDUFA target action date of November 9, 2025 RGX-121 on track to be the first gene therapy and one-time treatment for MPS II Partner Nippon Shinyaku to lead commercialization upon potential approval REGENXBIO to lead commercial manufacturing …