Investing.com -- Unicycive Therapeutics (NASDAQ:UNCY) stock rose 3% Thursday morning after the company announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC).
The FDA deemed the resubmission a Class II complete response with a six-month review period, setting a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026. OLC is Unicycive’s investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis.
"We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC," said Shalabh Gupta, CEO of Unicycive. "We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year."
The NDA is supported by data from three clinical studies, multiple preclinical studies, and chemistry, manufacturing and controls data. According to the company, the FDA did not raise concerns about OLC’s preclinical, clinical, or safety data included in the original submission.
Unicycive reported an unaudited cash position of $41.3 million in cash, cash equivalents, and short-term investments at the end of 2025. The company stated this will fund continued advancement of OLC commercial launch activities and provides a cash runway into 2027.
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