Povetacicept (ALPN-303)
Immunoglobulin A nephropathy · Adults with immunoglobulin A nephropathy
VRTX · Vertex Pharmaceuticals Incorporated
Regulatory designations
Full timeline
6 milestonesFDA decision expected
FDA assigned a November 30, 2026 PDUFA target action date to the BLA seeking accelerated approval of povetacicept.
Vertex — BLA acceptance and PDUFA date↗FDA accepted the BLA
FDA accepted the application for adults with IgA nephropathy. Vertex used a Priority Review Voucher to shorten the review timeline.
Vertex — BLA acceptance↗Vertex completed the rolling BLA submission
Vertex completed the application seeking accelerated approval after positive interim data from the Phase 3 RAINIER trial.
Vertex — Completed rolling BLA submission↗RAINIER met its interim-analysis objectives
Povetacicept produced a 49.8% reduction in proteinuria versus placebo at Week 36 and met both alpha-controlled secondary endpoints.
Vertex — Positive Phase 3 RAINIER interim results↗Related News
No related news available.