Posted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application for clemidsogene lanparvovec (RGX-121) for the treatment of mucopolysaccharidosis II, also known as Hunter syndrome.
The PDUFA goal date has been extended from 9 November 2025 to 8 February 2026.
