Benzinga | Nov 30, 2021 04:13PM EST

Unicycive Therapeutics Receives FDA Guidance On Renazorb Regulatory Pathway

Unicycive Therapeutics Inc (NASDAQ: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.