FDA rejects Unicycive and Sobi filings over contract manufacturing deficiencies
The FDA turned away Unicycive's kidney drug and Sobi's gout combination therapy in the same week, citing contract manufacturing deficiencies at third-party facilities.
Unicycive Therapeutics
Unicycive Therapeutics is a clinical-stage biopharmaceutical company developing novel therapies for kidney diseases, including phosphate-binding agents for hyperphosphatemia in chronic kidney disease and dialysis patients.
Company Info
Sector:Small Molecule Pharma
Headquarters:Los Altos, California, United States
Founded:2016
Website:unicycive.com/
Upcoming Milestones & Key Dates
2026-08
Earnings
Q2 2026 Earnings Call
2026-Q3
Regulatory
OLC NDA resubmission (post-CRL)
Clinical Development Pipeline
Oxylanthanum carbonate (UNI-493 / OLC)
Target: Phosphate binderUNI-494
Target: Mitochondrial activatorUNI-200
Target: Next-gen phosphate binderRecent News
Leadership Team
Shalabh Gupta
Chairman, Chief Executive Officer and Founder
John A. Barbuto
Chief Operating Officer
Pramod Gupta
Vice President of Clinical Operations