Shots:The US FDA has accepted BLA & granted priority review to tividenofusp alfa for the treatment of Hunter syndrome (MPS II), with PDUFA target action date of Jan 5, 2026BLA was supported by a P-I/II trial of tividenofusp alfa in 47 MPS II pts, as Denali prepares for its US commercial launch. It…
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…

