Unicycive Therapeutics, Inc. (UNCY), Thursday announced the the U.S. Food and Drug Administration has accepted the resubmission of its New Drug Application for oxylanthanum carbonate or OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
The agency has set a Prescription Drug User Fee Act or PDUFA target action date of June 29, 2026.
The application was based on findings from three clinical studies, multiple preclinical studies as well as chemistry, manufacturing and controls data.
At 2025 end, the company had cash, cash equivalents, and short-term investments of $41.3 million, which is expected to support the continued advancement of OLC commercial launch activities and a cash runway into 2027.
In the pre-market hours, UNCY is trading at $7.05, up 0.43 percent on the Nasdaq.
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