UNCY News & Events

Unicycive Therapeutics 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 Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease, CKD, on dialysis. The Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act, PDUFA, target action date of June 27, 2026. "We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with chronic kidney disease on dialysis who continue to struggle with hyperphosphatemia."

Unicycive Therapeutics resubmitted its 505(b)(2) New Drug Application to the U.S. Food and Drug Administration for oxylanthanum carbonate, the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The NDA for OLC was resubmitted based on continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the single deficiency identified in the Company's Complete Response Letter related to the compliance status of the vendor. No additional issues were raised by the FDA. Following receipt of the CRL in June 2025, European Union regulatory authorities inspected the original third-party manufacturing vendor and identified no deficiencies. The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 months.