Unicycive resubmits FDA NDA for oxylanthanum carbonate for dialysis CKD hyperphosphatemia
Unicycive Therapeutics resubmitted its FDA NDA for oxylanthanum carbonate phosphate to treat hyperphosphatemia in CKD patients on dialysis, including CMC data from a new manufacturing vendor. FDA issued no clinical efficacy or safety issues, with a new PDUFA date expected in six months after prior CRLs in June 2025 and June 2026 citing third-party manufacturing deficiencies.
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Sept 29 (Reuters) — Unicycive Therapeutics Inc: Unicycive Therapeutics Announces Resubmission Of New Drug Application For Oxylanthanum Carbonate Unicycive Therapeutics - Fda Acceptance Of Nda Expected Within 30 Days; New Pdufa Date In 6 Months Unicycive Therapeutics - Nda Resubmission Includes Cmc Data From New Manufacturing Vendor Unicycive Therapeutics - Fda Inspection Of Original Manufacturing Vendor Assigned But Not Completed As Of Sept 29, 2026 Source text:... Further company coverage: UNCY.O (Reuters.Briefs@thomsonreuters.com;;)