Unicycive Therapeutics (NASDAQ:UNCY) shares climbed about 3% on Thursday after the company said the U.S. Food and Drug Administration has accepted the resubmission of its New Drug Application for oxylanthanum carbonate (OLC).
The FDA classified the filing as a Class II complete response, triggering a six-month review timeline and setting a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026. OLC is being developed as an oral phosphate binder for patients with hyperphosphatemia who have chronic kidney disease and are 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 application is backed by results from three clinical trials, a series of preclinical studies, and supporting chemistry, manufacturing and controls data. Unicycive noted that the FDA did not flag any issues related to the drug’s preclinical, clinical or safety data included in the original submission.
The company also disclosed an unaudited cash balance of $41.3 million in cash, cash equivalents and short-term investments as of the end of 2025. Management said this funding is expected to support ongoing launch preparations for OLC and extend the company’s cash runway into 2027.