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Vertex Announces Progress in Povetacicept Development Program and Presentation of New Data at American Society of Nephrology Kidney Week
- Food and Drug Administration grants rolling review of Biologics License Application for povet...
About this update from Vortex Energy Corp.
[{"type":"text","content":"Vertex Announces Progress in Povetacicept Development Program and Presentation of New Data at American Society of Nephrology Kidney Week\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }\n.bwuline { text-decoration: underline }\n \n\n\n\n -\n \n Food and Drug Administration grants rolling review of Biologics License Application for povetacicept in IgA nephropathy; Vertex to submit first module before end of year -\n \n\n\n -\n \n Second pivotal development program of povetacicept underway with Phase 2b/3 trial initiation in primary membranous nephropathy -\n \n\n\n -\n \n Updated data from RUBY-3 trial of povetacicept accepted for late breaking oral presentation; inaxaplin study design and APOL1-mediated kidney disease related data accepted for poster presentation -\n \n\n\n\n\n\n Vertex Pharmaceuticals Incorporated\n \n (Nasdaq: VRTX) today announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases.\n \n\n\n\n Next Steps for Pove Development\n \n\n\n\n\n In IgAN\n \n\n\n Following the\n \n announcement\n \n that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application (BLA) for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before the end of 2025. The Company remains on track to complete the full BLA submission for accelerated approval in the U.S. in the first half of 2026, if results from the planned interim analysis are supportive.\n \n\n\n In pMN\n \n\n\n Vertex announced it has initiated OLYMPUS, a Phase 2b/3 pivotal study of pove for the treatment of pMN, the second indication in which pove has best-in-class potential. There are no therapies specifically approved for the treatment of pMN.\n ...