• 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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Unicycive Therapeutics Inc. published the original content used to generate this news brief on September 09, 2026, and is solely responsible for the information contained therein.