Also known as FK506, Prograf, Advagraf, Astagraf XL, and Envarsus XR.
Phase 2 trial compares pegrizeprument with tacrolimus in up to 120 de novo kidney transplant recipients; primary endpoints are safety, pharmacokinetics and pharmacodynamics.
Priority Review follows MAJESTY phase III showing 36.9% complete remission at two years vs 5.7% with tacrolimus; FDA decision expected by Nov 2026.
FDA granted priority review for obinutuzumab in pMN after Phase III MAJESTY showed markedly higher complete remission vs tacrolimus; FDA decision expected Nov 2026.
Phase III study shows Gazyva achieves higher remission rates in membranous nephropathy, with safety consistent and no new signals. Data to be shared with health authorities.
Phase III study shows Gazyva achieves significant remission in primary membranous nephropathy, with safety profile consistent and no new signals. Data to be shared with health authorities.
