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Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd. manufactures and sells pharmaceuticals and foodstuffs in Japan and internationally. The company operates through Pharmaceuticals and Functional Food Business segments. It offers drugs in the fields of urology, hematology, intractable and rare diseases, gynecology, and other diseases; health food ingredients, preservatives, protein preparations, and supplements. The company in the Strategic Partnership with Nippon Shinyaku to develop ATSN-10 that is in Phase I/II of clinical trials for the treatment of GUCY2D-mutant Leber congenital amaurosis; and RGX-121 for the treatment of mucopolysaccharidosis. Nippon Shinyaku Co., Ltd. was founded in 1911 and is headquartered in Kyoto, Japan.

Price · split & dividend adjusted
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Biotech & Genomic Medicineimpact 4

FDA Clinical Hold on RGX-121 Sends REGENXBIO Stock Down 25%

REGENXBIO shares plunged 24.9% on Monday after the FDA placed a clinical hold on its investigational gene therapy RGX-121 for Mucopolysaccharidosis Type II, also known as Hunter syndrome. The hold followed asymptomatic spine MRI findings in five participants in the phase I/II/III CAMPSIITE study, who had received RGX-121 approximately three to six years earlier. The company no longer expects to resubmit the biologics license application for RGX-121 in the near term, after previously planning a third-quarter 2026 resubmission. REGENXBIO and NS Pharma are evaluating additional patient imaging and longer-term follow-up data and will incorporate FDA feedback into next steps. Attention is likely to shift to other pipeline programs, including RGX-202 for Duchenne muscular dystrophy, for which a BLA is planned in the third quarter of 2026.
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Biotech & Genomic Medicine2

AB2 Bio receives $30 million from Nippon Shinyaku for exclusive U.S. commercialization rights to Tadekinig Alfa

AB2 Bio has received a $30 million payment from Nippon Shinyaku after the Japanese company exercised its exclusive U.S. commercialization option for Tadekinig alfa, an investigational therapy for Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome in patients with NLRC4 and XIAP mutations. The option exercise triggers a payment under the companies' 2025 agreement, with AB2 Bio also eligible for up to $100 million in development milestones and up to $500 million in commercial milestone and royalty payments, bringing the total potential milestone and royalty value to $600 million. AB2 Bio retains worldwide rights to Tadekinig alfa for all other indications and all ex-U.S. rights for the lead indication, and will continue to lead Biologics License Application preparation and U.S. regulatory activities. The therapy has received Orphan Drug Designation in the U.S. and Europe, as well as Breakthrough Therapy and Rare Pediatric Disease Designations from the FDA.
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Biotech & Genomic Medicine3

Nippon Shinyaku and Elixirgen Therapeutics Enter Option Agreement for EXG-7001 in Duchenne Muscular Dystrophy

Nippon Shinyaku has entered into an option agreement with Elixirgen Therapeutics under which Nippon Shinyaku may obtain exclusive worldwide rights to develop and commercialize EXG-7001 for the treatment of Duchenne muscular dystrophy. EXG-7001 is an investigational mRNA-based therapeutic that expresses full-length human dystrophin protein, intended to suppress local muscle dysfunction regardless of genetic mutation. Elixirgen is currently preparing for clinical trials in the United States, and following option exercise and regulatory approval, NS Pharma, a wholly owned subsidiary of Nippon Shinyaku, intends to commercialize the therapy. The agreement was facilitated by the NS Pharma Innovation Research Partnering team.
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Biotech & Genomic Medicine

Nippon Shinyaku enters sponsored research agreement with Boston Children's Hospital

Nippon Shinyaku, the parent company of NS Pharma, has entered into a Sponsored Research Agreement with Boston Children's Hospital to develop innovative neurologic therapies. The agreement was facilitated by the NS Pharma Innovation Research Partnering team and builds on a strategic collaboration announced in July 2025. Under the deal, Nippon Shinyaku will integrate Boston Children's Hospital's research capabilities with its own drug discovery expertise to accelerate new treatments for patients with unmet medical needs.
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