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FDA Grants Vertex Kidney Disease Drug Breakthrough Therapy Designation

Provided by Dow Jones Sep 25, 2025, 12:25:00 PM

By Nicholas G. Miller

The FDA granted breakthrough therapy designation to a Vertex Pharmaceuticals kidney disease drug.

The drug, called povetacicept, is used for the treatment of IgA nephropathy, a type of kidney disease. It is being studied in a Phase 3 trial. Vertex said it was on track to file for accelerated approval in the first half of 2026 if its 36-week interim analysis data from the trial is positive.

Vertex also said it completed enrollment for the interim analysis cohort of a trial studying its inaxaplin drug used to treat APOL1-Mediated Kidney Disease and had begun a proof-of-concept study of its VX-407 drug to treat Autosomal Dominant Polycystic Kidney Disease.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

September 25, 2025 08:25 ET (12:25 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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