Tag: JPX:4565.T

Tokyo, Japan and Cambridge, UK, 2 June 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”)　 announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026.

Tokyo, Japan and Cambridge, UK, 6 August 2025 – Nxera Pharma Co., Ltd. (“Nxera”; TSE: 4565) a technology-powered biopharmaceutical company, today announces the launch of a broad new pipeline strategically focused on advancing next-generation therapies for obesity and associated metabolic disorders.

Tokyo, Japan and Cambridge, UK, 4 July 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that it will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals pursuant to its research collaboration with Centessa. The milestones were achieved as Centessa initiated clinical development of ORX142, its second novel orexin receptor 2 (OX2R) agonist, following the recent clearance of an Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for a Phase 1 clinical study of ORX142 in healthy volunteers. (click here).