Unicycive Therapeutics Faces FDA Compliance Delay

Unicycive Therapeutics ( (UNCY) ) has issued an announcement.

On June 10, 2025, Unicycive Therapeutics announced an update on its New Drug Application for oxylanthanum carbonate, intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, delaying label discussions and a final decision is expected by June 28, 2025. Despite these challenges, Unicycive remains confident in the potential of oxylanthanum carbonate based on extensive clinical data and is working with partners to address the FDA’s concerns.

The most recent analyst rating on (UNCY) stock is a Buy with a $3.00 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 is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The company is also developing UNI-494 for acute kidney injury conditions, which has received orphan drug designation for preventing Delayed Graft Function in kidney transplant patients.

Average Trading Volume: 1,649,874

Technical Sentiment Signal: Buy

Current Market Cap: $91M

Find detailed analytics on UNCY stock on TipRanks’ Stock Analysis page.