Unicycive Therapeutics Receives FDA Guidance On Renazorb Regulatory Pathway

Unicycive Therapeutics Inc UNCY updated the development and regulatory filing pathway for Renazorb (lanthanum dioxycarbonate). 

• Renazorb is a second-generation lanthanum-based phosphate-binding agent utilizing proprietary nanoparticle technology for hyperphosphatemia in patients with chronic kidney disease (CKD).
• In a recent Type C interaction with the FDA, Unicycive sought the FDA's feedback on the sufficiency of the Renazorb data package to support a 505(b)(2) new drug application (NDA) submission. 
• Unicycive provided results from in vitro studies conducted to support the comparability of Renazorb and its active lanthanum moiety to the approved product Fosrenol. 
• The FDA confirmed in their response that the phosphate-binding mechanism and stoichiometry of Renazorb are comparable to Fosrenol.
• Together with the previously agreed-upon 6-month mouse toxicology, the additional bioequivalence study will provide the necessary bridge to support the NDA submission. 
• No additional pre-clinical or clinical studies are currently expected to be required in support of an NDA submission for Renazorb.
• See here Benzinga's Full FDA Calendar.
• The Company reaffirmed its previous guidance to submit an NDA for Renazorb in Q4 of 2022.
• Price Action: UNCY shares are down 2.40% at $2.85 during the market session on the last check Monday.