Climb Bio Gets FDA Fast-Track Designation for Budoprutug in Rare Kidney Disease
By Colin Kellaher
Climb Bio has won the Food and Drug Administration's fast-track designation for its proposed budoprutug treatment for the rare kidney disease primary membranous nephropathy, or pMN.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Climb Bio on Tuesday said there are currently no FDA-approved treatments for pMN, which affects about 75,000 people in the U.S. and can lead to chronic or end-stage kidney disease, requiring dialysis or transplantation.
The Wellesley Hills, Mass., clinical-stage biotechnology company, which is conducting a Phase 2 study of budoprutug in pMN, said it expects to share initial data from the study in the second half of 2026.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 07, 2026 07:39 ET (11:39 GMT)
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