Vertex Pharmaceuticals Incorporated (VRTX) announced the FDA has accepted its Biologics License Application submission for povetacicept, an investigational engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in adults with immunoglobulin A nephropathy. The FDA has assigned a PDUFA target action date of November 30, 2026. If povetacicept is approved by the FDA, Vertex plans to launch povetacicept in a low-volume.
The submission is supported by positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept in IgAN.
In pre-market trading on NasdaqGS, Vertex shares are down 0.24 percent to $446.45.
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