Unicycive Therapeutics, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsUnicycive Therapeutics is a clinical-stage biotech developing two kidney-disease drug candidates, with its lead program, oxylanthanum carbonate, awaiting FDA approval after receiving a second Complete Response Letter.
What they do
Unicycive is a clinical-stage biotechnology company focused on developing therapies for kidney disease. Its lead candidate, oxylanthanum carbonate (OLC), is a next-generation phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and its second candidate, UNI-494, is for acute kidney injury. The company licenses technologies and drugs, then develops and seeks regulatory approval, with plans to commercialize in the U.S. and partner globally.
Revenue drivers
- Oxylanthanum carbonate (OLC) — Lead product candidate; no commercial revenue yet; potential revenue driver if FDA-approved for hyperphosphatemia in dialysis patients.
- UNI-494 — Second product candidate for acute kidney injury; still in clinical development; no revenue.
- Licensing and partnerships — Business model includes potential global partnerships for commercialization outside the U.S.; no revenue from this yet.
Recent performance
For Q2 2026, Unicycive reported a net loss of $1.7 million, or $(0.06) per share, compared to a net loss of $6.5 million, or $(0.52) per share, in Q2 2025. R&D expense was $2.8 million in Q2 2026, up from $1.8 million in Q2 2025, driven by higher stock-based compensation. G&A expense rose to $7.4 million from $5.2 million, partly due to commercial launch preparation. As of June 30, 2026, cash, cash equivalents, and marketable securities totaled $61.4 million.
Strategy
Unicycive is prioritizing resubmission of the NDA for OLC after addressing FDA manufacturing deficiencies. The company is investing in commercial readiness, including the UniSource reimbursement hub, and engaging with patient and clinical communities at medical meetings. Management aims to launch OLC quickly upon approval and to expand market awareness. The company also plans to continue development of UNI-494 for acute kidney injury.
Risks
- Regulatory setback risk — Received a second Complete Response Letter from the FDA in June 2026 due to third-party manufacturing deficiencies, delaying OLC approval.
- Dependence on third-party manufacturer — FDA approval depends on successful inspection of a third-party manufacturing vendor; any failure could further delay or prevent approval.
- No product revenue and ongoing losses — Company has generated no product revenue and expects continued net losses for at least the next several years.
- Capital needs — Requires sufficient capital to fund operations; cash runway is expected into 2027, but additional financing may be needed.
Outlook
Management expects to resubmit the OLC NDA after the FDA inspection of the third-party manufacturing vendor is completed. The FDA has assigned the facility inspection, and the company plans to provide an update afterward. Management is optimistic about a successful inspection and continues commercial preparation, with cash runway into 2027.