Posted by Michael Wonder on 30 Dec 2025
Unicycive Therapeutics announces resubmission of new drug application for oxylanthanum carbonate
29 December 2025 - New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission.
Unicycive Therapeutics today announced that it has resubmitted its 505(b)(2) new drug application to the US FDA for oxylanthanum carbonate the Company’s investigational oral phosphate binder for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis.
