FDA, Unicycive Agree On Path To File NDA For Oxylanthanum Carbonate

(RTTNews) - Unicycive Therapeutics, Inc. (UNCY) Monday said it has reached an agreement with the Food and Drug Administration (FDA) on the path to file a New Drug Application for Oxylanthanum Carbonate (OLC) to treat Hyperphosphatemia.

Hyperphosphatemia is a condition of having too much phosphorus in the blood, the most common cause of which is chronic kidney disease (CKD).

The regulator has agreed with the company's design of the study to evaluate the tolerability of clinically effective doses of OLC in 60 participants with CKD, Unicycive said.

The company plans to start a pivotal study for OLC before the end of the year, with topline data expected in the second quarter of 2024.

Unicycive added that its cash position as on June 30, 2023 was $18.8 million, which is expected to last till the second half of 2024, and enough to complete the study.