Unicycive Therapeutics (NASDAQ:UNCY) said it has resubmitted its 505(b)(2) New Drug Application to the U.S. Food and Drug Administration for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients receiving dialysis.
The company said it expects to receive a new Prescription Drug User Fee Act date in the first half of 2026.
Acceptance of the resubmitted application is typically acknowledged by the FDA within 30 days, with a target review period of six months, Unicycive said.
The resubmission follows progress by the original third-party manufacturing vendor toward FDA compliance, as well as a Type A meeting with the regulator in September 2025 in which no additional issues were raised.
The company also cited a recent European Union inspection of the manufacturing facility that identified no deficiencies.
Unicycive said it believes it has sufficient cash to fund operations into 2027, positioning the company to support regulatory review and potential commercialization activities if the drug is approved