Unicycive Therapeutics received a Complete Response Letter from the FDA for its resubmitted New Drug Application for oxylanthanum carbonate, a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA raised no concerns about clinical efficacy or safety and requested no additional data. The letter cites the same third-party manufacturing deficiencies that led to a previous Complete Response Letter in June 2025, and the FDA has not yet inspected that vendor. Unicycive had resubmitted the application based on the vendor's progress in resolving the deficiencies, which was discussed at a Type A meeting with the FDA in September 2025 where no new issues were raised.
Unicycive Therapeutics IncFDA issued Complete Response Letter due to third-party manufacturing deficiencies, delaying approval
Commercial Metals Company