FDA accepts Unicycive's NDA for Oxylanthanum Carbonate; PDUFA date June 28, 2025

Unicycive Therapeutics, Inc.

FDA accepted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.
PDUFA target action date set for June 28, 2025; company preparing for commercial launch in H2 2025.
FDA granted a waiver for the NDA application PDUFA fees, saving approximately $4 million.
OLC aims to reduce pill burden vs. current options (up to 12 pills/day); pills are swallowed, not chewed.

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