Unicycive receives FDA request for additional data on LDC NDA; timeline extended

Unicycive Therapeutics, Inc.

FDA asked for risk assessment and clinical data to evaluate tolerability of lanthanum dioxycarbonate in dialysis patients.
Pre-NDA meeting revealed quantitative differences in GI adverse findings between LDC and lanthanum carbonate.
Company plans follow-up meeting with FDA and expects further updates in Q3 2023.
Bioequivalence to Fosrenol was previously established in Phase I studies; no GI neoplasms seen in mouse study.
LDC targets hyperphosphatemia in CKD dialysis patients; global market opportunity >$2.5B in 2023.

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