Tuesday, March 31, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
NDA Sumisssion Was Accepted In January. Unicycive reported loss for FYQ25 of $26.6 million or $(1.67) per share. Importantly, the resubmission of the NDA for oxylanthanum calcium (OLC), its phosphate binder for controlling high phosphate levels in renal dialysis patients, was accepted for filing by the FDA. The PDUFA data is June 19, 2026. Cash on December 31, 2026 was $54.9 million, which we estimate is sufficient to last through product launch and the first quarter of OLC sales.
We Believe Previous Issues Have Been Settled. The NDA was submitted in December 2025 and accepted for filing in January. FDA acceptance and notification of the PDUFA date signifies that the application is complete for review. There were no questions about the third-party manufacturing issue that stopped the review process in June 2025. We believe the corrective actions have addressed the problem, allowing for marketing approval by June 2026.
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