Vertex reports strong Week 36 interim results for povetacicept in IgA nephropathy

Vertex’s povetacicept demonstrated robust Week 36 interim efficacy in the Phase 3 RAINIER trial for IgA nephropathy, including a 52.0% reduction in 24-hour UPCR (49.8% versus placebo, P<0.0001), a 77.4% reduction in serum Gd-IgA1 (79.3% versus placebo; P<0.0001), and 85.1% hematuria resolution versus 23.4% with placebo (61.7-point difference; P<0.0001). The drug was generally safe and well tolerated. Vertex plans full BLA submission by end of March for potential accelerated FDA approval, with final efficacy analysis scheduled at two years through Week 104.