UNCY - Unicycive Therapeutics pops 6% after receiving FDA guidance on Renazorb regulatory pathway

Unicycive Therapeutics (NASDAQ:UNCY) perks up 6.2% premarket after providing an update on the development and regulatory filing pathway for Renazorb (lanthanum dioxycarbonate) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). In a recent Type C interaction with the FDA, Unicycive sought the Agency's feedback on the sufficiency of the Renazorb data package to support a 505(b)(2) new drug application submission (NDA). Unicycive provided results from in vitro studies conducted to support the comparability of Renazorb and its active lanthanum moiety to the approved product Fosrenol. Based on these data, the FDA confirmed in their response that the phosphate-binding mechanism and stoichiometry of Renazorb is comparable to Fosrenol. The FDA also confirmed their previous guidance that Unicycive may support the NDA filing of Renazorb based on a single clinical bioequivalence study performed in healthy volunteers demonstrating comparable changes in urinary phosphate excretion between Renazorb and Fosrenol. No additional pre-clinical

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Unicycive Therapeutics pops 6% after receiving FDA guidance on Renazorb regulatory pathway