Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate
Key Highlights
- ➤Unicycive Therapeutics (UNCY) resubmits OLC NDA with new vendor CMC data
- ➤OLC resubmission includes 12 months of drug product stability data
- ➤FDA acceptance anticipated within 30 days; new PDUFA date expected six months after resubmission
- ➤$61.4 million cash, cash equivalents and securities supports runway into 2H 2027
- ➤FDA’s 2026 CRL cited manufacturing deficiencies, not clinical efficacy or safety concerns
Expert Statements
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics
“We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options.”
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics
“By adding an alternative primary manufacturing vendor, we are positioning the NDA for expedient review and potential approval.”
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics
“If the FDA’s assigned inspection of the original vendor is completed favorably in the interim, that outcome could provide a potential timing benefit.”
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics
“We continue to advance commercial readiness activities in anticipation of a potential launch, with the goal of helping patients with CKD on dialysis who continue to struggle with hyperphosphatemia.”
* Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor * The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor * Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission * Current cash position allows runway into 2H 2027 MOUNTAIN VIEW, Calif., Sept. 29, 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 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 Company anticipates United States Food and Drug Administration (FDA) acceptance of the NDA within 30 days and a new assigned PDUFA date to be six months from the date of resubmission.
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