Unicycive Therapeutics (UNCY) has maintained a bullish outlook following the New Drug Application (NDA) submission for Oxylanthanum Carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. Maxim Group analyst Jason McCarthy reaffirmed a 'Buy' rating on September 3, citing the potential approval of OLC as a significant revenue opportunity.
The FDA's waiver of associated PDUFA fees for OLC is a notable cost-saving benefit for Unicycive. McCarthy views the NDA filing risk as relatively low, supported by a study demonstrating favorable tolerability and potential best-in-class efficacy, with a high degree of phosphate control observed. Hyperphosphatemia, a common complication in chronic kidney disease, affects a significant portion of dialysis patients and is associated with increased morbidity and mortality.
Financial Outlook and Analyst Perspective
Despite a reduction in the 12-month price target for Unicycive's stock due to uncertainties concerning the transitional drug add-on payment adjustment (TDAPA) period and the timing for CMS implementing the dialysis bundle, McCarthy anticipates these uncertainties will resolve soon. The projected approval of OLC could unlock a significant revenue opportunity. The company’s financial position is reportedly sound, with funding anticipated to last into 2026, and the promise of a substantial dividend payout from operating cash flow adds to the investment’s appeal.
Additional Analyst Support
H.C. Wainwright also maintained a 'Buy' rating on the stock with a $2.50 price target in a report released on September 3, further bolstering confidence in Unicycive's prospects.
Unicycive's Pipeline
Unicycive Therapeutics Inc. focuses on developing treatments for kidney diseases. The company’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. Unicycive’s other drug, UNI-494, is a new chemical entity in late preclinical development for the treatment of acute kidney injury.
