Calico Life Sciences Announces U.S. FDA Orphan Drug Designation For Investigational Treatment Of Autosomal Dominant Polycystic Kidney Disease

Author: Benzinga Newsdesk | November 05, 2025 10:08am

Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). ABBV-CLS-628, an anti-PAPP-A monoclonal antibody, was developed by Calico in collaboration with AbbVie Inc. The therapy was recently granted Fast Track Designation by the FDA and is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with ADPKD.

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