Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

Shots: Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the US AB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…

ByRidhi Rastogi5 hours ago

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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, 2025 As per Jan 2025 partnership, NS Pharma (Nippon Shinyaku’s subsidiary) will commercialize RGX-121 in the US post approval while REGENXBIO will handle…

ByRidhi RastogiMay 14, 2025

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…

BySenior EditorJanuary 15, 2025

Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

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

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

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