Unicycive Therapeutics outlines oxylanthanum carbonate program for hyperphosphatemia in dialysis patients - UNCY News | RalliesUnicycive Therapeutics outlines oxylanthanum carbonate program for hyperphosphatemia in dialysis patients
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UNCY• Unicycive outlines NDA resubmission plans and FDA manufacturing discussions
- Unicycive outlined near-term plans to resubmit the NDA for oxylanthanum carbonate, its lead program for hyperphosphatemia in dialysis patients.
- FDA discussions center on a pending inspection of a third-party manufacturing vendor cited for deficiencies in a complete response letter.
- Approval is expected in the near term if the NDA is resubmitted and manufacturing issues are cleared; cash runway is projected into 2027.
- The company reiterated a US hyperphosphatemia market opportunity of more than USD 1 billion, citing roughly 450,000 dialysis patients using binders.
- Pivotal study results highlighted 91% phosphate control in maintenance and 69% hitting target at ≤1,500 mg/day, with 6% discontinuations.
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