Unicycive Therapeutics seeks FDA approval for OLC to treat hyperphosphatemia, showing potential in patient surveys.

From GlobeNewswire: 2025-05-14 07:15:00

Unicycive Therapeutics’ NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis is under FDA review with a target action date of June 28, 2025. New data from patient surveys show adherence challenges, highlighting OLC’s market potential. Financial results for the quarter ended March 31, 2025, reveal a decrease in R&D expenses and an increase in G&A expenses.

The company is preparing for potential OLC approval by building key functions and engaging with stakeholders. Patient surveys at medical meetings highlighted the preference for regimens with fewer pills. Financially, R&D expenses decreased, G&A expenses increased due to commercial launch prep, and cash equivalents were $19.8 million as of March 31, 2025.

Unicycive Therapeutics focuses on developing novel kidney disease treatments. OLC, under FDA review, targets hyperphosphatemia in CKD patients on dialysis. Financially, the company’s balance sheet shows total assets of $27.9 million as of March 31, 2025. The company reported a net income of $0.5 million for the three months ended March 31, 2025.



Read more at GlobeNewswire:: Unicycive Therapeutics Announces First Quarter 2025