Climb Bio, Inc. (CLYM), Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to budoprutug for the treatment of primary membranous nephropathy, a rare kidney disease.
The company believes that the designation would accelerate the budoprutug development efforts and facilitate closer interaction with the FDA.
At present, budoprutug is being studied in a Phase 2 global open-label, dose-range finding study. The company expects to announce initial data from this study in the second half of 2026.
Meanwhile, previously announced Phase 1b study data showed that administration of budoprutug led to complete peripheral B-cell depletion in all patients, serologic remission in all evaluable patients, and complete or partial clinical remission in all participants by week 48.
Further, long-term follow-up data demonstrated durable reductions in proteinuria, supporting further investigation of budoprutug as a potential disease modifying therapy.
In the pre-market hours, CLYM is trading at $6.99, up 3.71 percent on the Nasdaq.
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