Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update

Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026

Mar. 30, 2026 at 11:28am

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A high-end, photorealistic studio still-life photograph featuring a stack of pill bottles and a medical syringe arranged elegantly on a clean, white seamless background, conveying a sense of precision, innovation, and hope in the development of new kidney disease treatments.Unicycive Therapeutics' potential new kidney disease treatment nears FDA approval, offering hope for patients struggling with uncontrolled hyperphosphatemia.Los Altos Today

Unicycive Therapeutics, a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced its financial results for the full year ended December 31, 2025, and provided a business update. The company's lead investigational treatment, oxylanthanum carbonate (OLC), is currently under review by the FDA for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis, with a PDUFA target action date of June 29, 2026. Unicycive is also continuing to strengthen its commercial infrastructure and advance market readiness initiatives in anticipation of a potential OLC launch later this year.

Why it matters

Hyperphosphatemia, or high phosphate levels in the blood, is a common and serious complication for patients with chronic kidney disease on dialysis. OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.

The details

Unicycive's NDA resubmission for OLC is supported by data from three clinical studies, multiple preclinical studies, and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product.

  • In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC.
  • The FDA set a PDUFA target action date of June 29, 2026.

The players

Unicycive Therapeutics, Inc.

A clinical-stage biotechnology company developing therapies for patients with kidney disease.

Shalabh Gupta, M.D.

Chief Executive Officer of Unicycive.

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What they’re saying

“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration's acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year.”

— Shalabh Gupta, M.D., Chief Executive Officer of Unicycive

What’s next

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The takeaway

With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.