Unicycive reaches FDA alignment on NDA path for OLC; pivotal trial to start by end of 2023

Unicycive Therapeutics, Inc.

FDA agreed on full NDA package requirements: clinical, preclinical, and CMC data for Oxylanthanum Carbonate (OLC).
Pivotal open-label trial to enroll 60 CKD dialysis patients; 4-week evaluation after dose titration.
Top-line data expected Q2 2024; no statistical analysis required; efficacy referenced from prior bioequivalence study.
Cash of $18.8M as of June 30, 2023 expected to fund trial and operations into H2 2024.
NDA to be filed via 505(b)(2) pathway referencing Fosrenol; only one clinical study required.

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