Unicycive Therapeutics Announces FDA Acceptance of Resubmitted NDA for Oxylanthanum Carbonate

Unicycive Therapeutics has announced that the FDA has accepted its Class II resubmission of the New Drug Application for oxylanthanum carbonate, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The resubmission includes updated CMC data from a new third-party manufacturer. The FDA set a PDUFA target action date of March 25, 2027, for the review's completion.