Skip to content Skip to footer
Subscribe Now
Regenxbio
NEWS

REGENXBIO Reports the US FDA’s BLA Acceptance and Priority Review of RGX-121 for Treating Mucopolysaccharidosis II

Shots:The US FDA has accepted BLA & granted priority review to RGX-121 (clemidsogene lanparvovec) for the treatment of Mucopolysaccharidosis II (MPS II or Hunter syndrome), with PDUFA action date of Nov 09, 2025As per Jan 2025 partnership, NS Pharma (Nippon Shinyaku’s subsidiary) will commercialize RGX-121 in the US post approval while REGENXBIO will handle…
May 14, 2025

Read more

NEWS

REGENXBIO Join Forces with Nippon Shinyaku to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS)

Shots:REGENXBIO & Nippon have partnered to develop RGX-121 (Hunter syndrome; FDA’s accelerated approval expected in late 2025, with ongoing rolling BLA filing) & RGX-111 (P-I/II study for Hurler syndrome) in the US & Asia. The closing is expected in Q1’25 REGENXBIO will get $110M upfront, ~$700M milestones ($40M development & regulatory + $660M…
January 15, 2025

Read more