Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 2026
Key Highlights
- ➤Povetacicept cut proteinuria 49.8% versus placebo at Week 36, meeting RAINIER’s primary endpoint
- ➤42.2% of treated participants reached UPCR below 0.5 g/g versus 6.2% on placebo
- ➤FDA PDUFA target action date remains November 30, 2026, for potential accelerated approval
- ➤Povetacicept achieved 79.3% greater Gd-IgA1 reduction versus placebo, meeting a secondary endpoint
- ➤85.1% of treated patients achieved hematuria resolution versus 23.4% on placebo
Expert Statements
Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex
“At just 36 weeks of treatment, povetacicept has delivered impressive efficacy results, together with favorable safety and convenient dosing at-home every 4 weeks in a low-volume auto-injector that can fit into the lives of IgAN patients, underscoring the potential of povetacicept to substantially impact and redefine expectations for disease control in IgAN”
Richard Lafayette, M.D., Professor of Medicine (Nephrology) at Stanford University Medical Center and RAINIER Steering Committee Co-Chair
“What stands out from the RAINIER results is the important clinical validation of simultaneously targeting BAFF and APRIL to address upstream drivers and kidney injury in IgA nephropathy. Povetacicept was specifically designed as a high-potency, high-affinity TACI fusion protein with broad tissue distribution to deliver this dual inhibition in order to target upstream pathogenic immune complex production”
Richard Lafayette, M.D., Professor of Medicine (Nephrology) at Stanford University Medical Center and RAINIER Steering Committee Co-Chair
“The results observed with povetacicept are among the most compelling I have seen in IgAN and highlight the potential of povetacicept to become an important new treatment option for patients living with this chronic progressive disease”
Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 2026
- Vertex is on track for the U.S. FDA Prescription Drug User Fee Act (PDUFA) date of November 30 for potential accelerated approval of povetacicept –
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