Mar. 30 at 9:06 PM
Unicycive Therapeutics (Nasdaq:
$UNCY) announced its financial results for the full year ended December 31, 2025, and provided a business update.
Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/unicycive.
The company continues to advance toward a potential commercial launch of OLC in the third quarter of 2026, while maintaining a cash position expected to fund operations into 2027 and reporting lower net loss year over year.
Among the highlights noted in the release:
• The FDA accepted the resubmission of the company’s NDA for oxylanthanum carbonate (OLC) in January 2026, setting a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in patients with CKD on dialysis), multiple preclinical studies, and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical, or safety data in the original NDA submission. The resubmission was based on progress made by a third-party manufacturing vendor responsible for the drug product.
• Commercial readiness activities are ongoing in anticipation of a potential OLC launch in 3Q26, including efforts to strengthen commercial infrastructure and advance market readiness initiatives.
• As of March 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled
$54.9 million, with expected runway into 2027.
• Net loss for FY2025 was
$26.6 million (
$1.67 per share), compared to
$37.8 million (
$5.65 per share) in FY2024, driven primarily by lower drug development and clinical trial costs.
• R&D expenses declined to
$9.1 million from
$20.0 million in the prior year, while G&A expenses increased to
$20.4 million from
$12.1 million, reflecting commercial launch preparation costs.
Dr. Shalabh Gupta, MD, CEO of Unicycive, commented, “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. 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.”
See today’s press release at https://ir.unicycive.com/news/detail/120/unicycive-therapeutics-announces-full-year-2025-financial.
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Learn more at Unicycive (https://unicycive.com/) and B2i Digital (https://b2idigital.com/).
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