Vertex Says Phase 3 RAINIER Trial Meets Primary Endpoint in IgAN
Povatacicept cut proteinuria 49.8% versus placebo at Week 36 (P<0.0001) and met both secondary endpoints. Vertex’s FDA BLA for accelerated approval is under review, with a Nov. 30, 2026 PDUFA date.
Vertex said interim results from the Phase 3 RAINIER trial, reported in NEJM/ASN, showed povetacicept reduced proteinuria by 49.8% versus placebo at Week 36 (P<0.0001). The trial also met both secondary endpoints. The FDA is reviewing the BLA for accelerated approval, with a Nov. 30, 2026 PDUFA date.