Unicycive Therapeutics (NASDAQ:UNCY), a clinical-stage biopharmaceutical company focused on kidney disease therapies, reported its full-year 2025 financial results and provided a business update on March 30, 2026.
The company announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) resubmission for oxylanthanum carbonate (OLC), a next-generation phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease.
The PDUFA target action date is June 29, 2026, and Unicycive stated that commercial readiness activities are underway for a potential launch in the third quarter of 2026.
For the full year 2025, Unicycive reported research and development expenses of $9.1 million, general and administrative expenses of $20.4 million, other income of $3 million, and a net loss of $26.6 million, or $1.67 per share.
As of March 30, 2026, the company had unaudited cash, cash equivalents and marketable securities of $54.9 million, which it expects will fund operations into 2027.