7 April 2026 - Climb Bio today announced that the US FDA has granted fast track designation to budoprutug, the company’s investigational anti-CD19 monoclonal antibody, for the treatment of primary membranous nephropathy—a rare kidney disease for which there are currently no FDA approved treatments.

As previously reported, administration of budoprutug in a completed Phase 1b study in primary membranous nephropathy demonstrated complete peripheral B-cell depletion in 100% (5/5) of patients, serologic remission in all (3/3) evaluable patients, and complete or partial clinical remission in all (5/5) participants by week 48.

Read Climb Bio press release