Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027
Key Highlights
- ➤FDA accepts Unicycive’s NDA resubmission for oxylanthanum carbonate
- ➤PDUFA target action date set for March 25, 2027
- ➤Class II resubmission carries a six-month FDA review period
- ➤Resubmission includes CMC data from a new third-party manufacturing vendor
- ➤Second CRL cited deficiencies at the original drug-product manufacturer
Expert Statements
Shalabh Gupta, Chief Executive Officer of Unicycive Therapeutics
“We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date”
Shalabh Gupta, Chief Executive Officer of Unicycive Therapeutics
“This resubmission includes CMC data from a new third-party drug product manufacturing vendor.”
Shalabh Gupta, Chief Executive Officer of Unicycive Therapeutics
“The new vendor’s facility was last inspected by the FDA in March 2024 and received ‘No Action Indicated’ status.”
Shalabh Gupta, Chief Executive Officer of Unicycive Therapeutics
“We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia.”
* Resubmission includes Chemistry, Manufacturing, and Controls (CMC) data from new drug product (DP) manufacturing vendor MOUNTAIN VIEW, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today 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 NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.
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