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Vertex Secures FDA Breakthrough For Povetacicept In IgAN, Completes AMKD Trial Enrollment, And Launches ADPKD Study In Push For First-In-Class Kidney Therapies

Author: Benzinga Newsdesk | September 25, 2025 07:49am

- Food and Drug Administration granted Breakthrough Therapy Designation for povetacicept in IgA nephropathy; on track to file for accelerated approval in the U.S. in H1 2026 if 36-week interim analysis data positive -

- Enrollment completed for interim analysis cohort of AMPLITUDE global Phase 2/3 trial evaluating inaxaplin in APOL1-mediated kidney disease; potential to file for accelerated approval in the U.S. if 48-week interim analysis data positive -

- Phase 2 proof-of-concept study initiated for VX-407 in patients with autosomal dominant polycystic kidney disease -

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced several important advancements across its programs in immunoglobulin A Nephropathy (IgAN), APOL1-mediated kidney disease (AMKD) and autosomal dominant polycystic kidney disease (ADPKD). These updates represent significant progress toward reaching the Company's goal of bringing forward first-in-class or best-in-class therapies that target the underlying cause of these serious kidney diseases.

Posted In: VRTX

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