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Unicycive Therapeutics ( (UNCY) ) just unveiled an update.
On October 28, 2025, Unicycive Therapeutics announced an update following a meeting with the FDA regarding its New Drug Application for Oxylanthanum Carbonate (OLC), after receiving a Complete Response Letter in June 2025. The meeting addressed a compliance issue with a third-party manufacturing vendor, and the company plans to resubmit the application by the end of the year. With a cash runway extending into 2027, Unicycive is positioned to support the resubmission, potential FDA approval, and launch of OLC, which could lead to a PDUFA date in the first half of 2026. OLC is designed to improve patient adherence by reducing pill burden for those with hyperphosphatemia, a condition affecting many patients with end-stage renal disease.
The most recent analyst rating on (UNCY) stock is a Buy with a $21.00 price target. To see the full list of analyst forecasts on Unicycive Therapeutics stock, see the UNCY Stock Forecast page.
Spark’s Take on UNCY Stock
According to Spark, TipRanks’ AI Analyst, UNCY is a Underperform.
Unicycive Therapeutics has significant financial challenges, including ongoing net losses and a reliance on debt for financing, which weigh heavily on its stock score. The technical analysis reveals a bearish trend, as the stock is trading below major moving averages. Valuation metrics further dampen the attractiveness of the stock due to negative profitability indicators. Without earnings call insights or recent corporate events to improve prospects, the overall score reflects these financial and technical weaknesses.
To see Spark’s full report on UNCY stock, click here.
More about Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company focused on developing novel treatments for kidney diseases. Its lead investigational treatment, Oxylanthanum Carbonate (OLC), is a phosphate binding agent aimed at treating hyperphosphatemia in patients with chronic kidney disease on dialysis. The company is also developing UNI-494 for acute kidney injury, which has received orphan drug designation for preventing Delayed Graft Function in kidney transplant patients.
Average Trading Volume: 429,768
Technical Sentiment Signal: Hold
Current Market Cap: $90.6M
See more insights into UNCY stock on TipRanks’ Stock Analysis page.