GlobeNewswire·Mar 30, 2026, 7:05 AM ET

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

Unicycive Therapeutics announced the FDA accepted its NDA resubmission for Oxylanthanum carbonate (OLC) with a PDUFA target action date of June 29, 2026.
Commercial readiness activities are ongoing in preparation for a potential OLC launch in the third quarter of 2026.
As of March 30, 2026, the company held $54.9 million in cash, cash equivalents, and marketable securities, providing a runway into 2027.
Research and development expenses decreased to $9.1 million in 2025 from $20.0 million in 2024 due to reduced drug development and clinical trial costs.
General and administrative expenses increased to $20.4 million in 2025 from $12.1 million in 2024, driven by consulting, professional services, and commercial launch preparation costs.
Net loss attributable to common stockholders narrowed to $26.6 million in 2025 from $37.8 million in 2024.
Other income shifted to $3.0 million in 2025 from a $4.6 million expense in 2024, primarily due to a decrease in the fair value of the company's warrant liability.
OLC is an investigational oral phosphate binder supported by data from three clinical studies, multiple preclinical studies, and CMC data, with no FDA concerns raised regarding previous safety data.
The company's second investigational treatment, UNI-494, received orphan drug designation for preventing Delayed Graft Function in kidney transplant patients.