Vertex Presents Updated Phase 1/2 Data From RUBY-3 Study That Continue to Demonstrate Best-in-Class Potential for Povetacicept in Adults with IgA Nephropathy and Primary Membranous Nephropathy at American Society of Nephrology Kidney Week

About this update from Vertex Pharmaceuticals Incorporated

- 48-week data show a 64% decrease from baseline in proteinuria in IgA nephropathy, 82% decrease from baseline in proteinuria in primary membranous nephropathy, and stabilization of estimated glomerular filtration rate across both diseases - - Vertex on track to initiate rolling submission of Biologics License Application for potential accelerated approval to the U.S. Food and Drug Administration this year; full enrollment completed for Phase 3 RAINIER trial in IgA nephropathy - - Povetacicept in primary membranous nephropathy granted Fast Track Designation by the U.S. Food and Drug Administration and Phase 2/3 pivotal trial initiated - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced updated data for povetacicept (pove) in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) from the ongoing RUBY-3 trial at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas . Pove is an investigational recombinant fusion protein therapeutic and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Results were presented today as a late-breaking oral presentation (SA-OR091) and included interim data from the open-label Phase 1/2 RUBY-3 trial, where adults with IgAN and pMN received pove subcutaneously every 4 weeks. The analysis included 21 participants with IgAN and 10 participants with pMN treated with pove at the 80mg dose, of which 17 participants and 5 participants, respectively, completed the Week 48 study visit. Results in IgAN In IgAN, key efficacy findings for the pove 80mg cohort at 48 weeks showed a 64% decrease from baseline in mean 24-hour urine protein to creatinine ratio (UPCR), estimated glomerular filtration rate (eGFR) stabilization with change from baseline in eGFR (mean±SE) of 3.3±3.1 mL/min/1.73m2, 90% (9/10) of participants achieving hematuria resolution (defined as a decrease to negative or small levels of urine blood in participants with baseline levels of urine blood of moderate or large), and 53% of participants achieving clinical remission (defined as UPCR

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