IR News 2025

Roche Announces Global Phase III INShore Study Topline Results on Gazyva for Idiopathic Nephrotic Syndrome in Children and Young Adults

Brogidirsen (NS-089/NCNP-02) for the treatment of Duchenne muscular dystrophy: 3.5-Year Clinical Trial Data Presented at the World Muscle Society 2025 Congress

Brogidirsen (NS-089/NCNP-02) for the treatment of Duchenne Muscular Dystrophy: Presenting 3.5-Year Clinical Trial Data at the World Muscle Society 2025 Congress

Orphan Drug Designation granted to Buloxibutid for the Treatment of Idiopathic Pulmonary Fibrosis in Japan

Lilly's antineoplastic agent Jaypirca® 50 mg and 100 mg tablets obtains additional approval as a treatment for relapsed or refractory chronic lymphocytic leukemia resistant or intolerant to other BTK inhibitors

FDA Grants Orphan Drug Designation to NS-051/NCNP-04 for the Treatment of Duchenne Muscular Dystrophy

FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

RGX-121 (clemidsogene lanparvovec) : Regarding the extension of the U.S. FDA review period

Notice Regarding Completion of Disposal of Treasury Stock as Restricted Stock Compensation

Outline of Consolidated Financial Results for the First Quarter Ended June 30, 2025

Nippon Shinyaku Selected as a Constituent of the FTSE4Good Index Series

Notice Regarding Disposal of Treasury Stock as Restricted Stock Compensation

CAP-1002: Capricor Therapeutics received Complete Response Letter from the U.S. FDA for Biologics License Application for Duchenne Muscular Dystrophy Cardiomyopathy

Nippon Shinyaku Selected as a Constituent of the SOMPO Sustainability Index

Announcement of Strategic Alliance with Boston Children's Hospital

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)