Unicycive Therapeutics (UNCY) said Monday that the US Food and Drug Administration has accepted its new drug application for oxylanthanum carbonate, and has set a target action date set of June 28, 2025.
The drug is a potential treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis, the company said.
Unicycive said it expects to commercialize oxylanthanum carbonate in the second half of 2025, subject to approval.
Unicycive shares were nearly 3% higher in premarket trading.
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