Posted by Michael Wonder on 13 May 2025
RegenxBio announces FDA acceptance and priority review of the BLA for RGX-121 for MPS II
13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025.
REGENXBIO today announced the US FDA has accepted for review the biologics license application seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of mucopolysaccharidosis II, also known as Hunter syndrome.
