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
Phase 3 RAINIER interim results for povetacicept in IgA nephropathy were published in NEJM and presented at ASN Kidney Week 2026, showing a 52.0% reduction from baseline in proteinuria at Week 36 and a 49.8% reduction versus placebo (P<0.0001), with both secondary endpoints met. Trial results support Vertex's BLA for accelerated approval in adults with IgAN, with the FDA PDUFA target action date set for November 30, 2026. Patient-preference data showed 96% of IgAN patients preferred an autoinjector over a prefilled syringe and 80% preferred dosing every 4 weeks versus weekly, supporting Vertex's planned at-home autoinjector launch.
Key figures
- Drug Name
- povetacicept
- Phase Of Trial
- Phase 3
- P value
- P<0.0001
- Pdufa date
- November 30, 2026
- Trial enrollment
- 605
- Hematuria resolution diff
- 61.7%
- Gd iga1 reduction vs placebo
- 79.3%
- Upcr below 0.5 g per g placebo
- 6.2%
- Proteinuria reduction vs placebo
- 49.8%
- Proteinuria reduction from baseline
- 52.0%
- Upcr below 0.5 g per g povetacicept
- 42.2%
- Upcr reduction vs placebo north america
- 54.2%
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