Unicycive Shares Rise After FDA Accepts Resubmission of Kidney Drug Application, Sets March 2027 Decision Date

Unicycive Therapeutics (UNCY) shares rose 8.06% to $4.10 after the U.S. Food and Drug Administration accepted its resubmitted New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA set a PDUFA target action date of March 25, 2027, under a Class II six-month review. The resubmission follows a Complete Response Letter in June 2026 citing deficiencies at the original third-party manufacturing facility, which the FDA could not reinspect during the prior review. The updated application includes Chemistry, Manufacturing, and Controls data from a new vendor whose facility received a No Action Indicated status after a March 2024 inspection. Unicycive said the FDA raised no concerns about OLC's clinical or preclinical data, including safety. The application is supported by three clinical studies and is filed under the 505(b)(2) pathway. The company said timing of any inspection of the original facility remains at the agency's discretion.