Unicycive Therapeutics announced its full year 2025 financial results, reporting a reduced net loss of $26.6 million and providing a business update on its lead drug candidate OLC, which has a PDUFA target action date of June 29, 2026.
Key takeaways
The FDA accepted the resubmission of the New Drug Application for oxylanthanum carbonate (OLC) in January 2026, with a PDUFA target action date of June 29, 2026.
Net loss attributable to common stockholders for the year ended December 31, 2025 was $26.6 million, or $1.67 per share, compared to $37.8 million, or $5.65 per share, for the same period in 2024.
Research and development expenses decreased to $9.1 million for 2025 from $20.0 million in 2024, while general and administrative expenses increased to $20.4 million from $12.1 million.
As of March 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027.
The company is continuing commercial readiness activities in anticipation of a potential commercial launch of OLC in the third quarter of 2026.