IR News 2025

RGX-121 (clemidsogene lanparvovec) : The U.S. FDA has accepted the Biologics License Application by REGENXBIO for Mucopolysaccharidosis II Disease

Outline of Consolidated Financial Results for the Year Ended March 31, 2025

FDA Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

Submission of New Drug Application for NS-401 (Tagraxofusp) in Japan

Launch of Uptravi® Tablets for Pediatric 0.05 mg for the Treatment of Pulmonary Arterial Hypertension in Japan

CAP-1002: The U.S. FDA has accepted the Biologics License Application for Duchenne Muscular Dystrophy Cardiomyopathy

Outline of Consolidated Financial Results for the Third Quarter Ended December 31, 2024

Termination of Litigation with Sarepta in Japan

Nippon Shinyaku and AB2 BIO enter into an Option Agreement for Commercialization of Tadekinig alfa for the treatment of NLRC4 mutation and XIAP deficiency in the U.S.

FDA Grants Rare Pediatric Disease Designation to NS-051/NCNP-04 for the Treatment of Duchenne Muscular Dystrophy

Nippon Shinyaku and REGENXBIO Enter into an Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis Diseases in the U.S. and Asia

NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy notice regarding publication of the results of an investigator-initiated clinical trial (First in human trial)