Unicyive Therapeutics is awaiting word on whether its main drug, oxylanthanum carbonate, will be approved to treat hyperphosphatemia in patients with chronic kidney disease on dialysis following a previous rejection.
- The company previously submitted the drug for approval but received a rejection letter last year.
- Unicyive Therapeutics fixed the manufacturing issue highlighted by the FDA and resubmitted its application in late 2025.
- H.C. Wainwright, which maintains a Buy rating and $22 price target on the stock, remains bullish on the upcoming decision.
Shares of Unicyive Therapeutics (UNCY) fell more than 16% on Friday as investors sold ahead of a major decision from the Food and Drug Administration on its lead drug due on Monday.
The stock is now on track for its worst day since late June 2025, if losses hold.
Impending Decision
The company is awaiting word on whether its main drug, oxylanthanum carbonate, will be approved to treat hyperphosphatemia in patients with chronic kidney disease on dialysis following a previous rejection.
The company previously submitted the drug for approval but received a rejection letter last year. The only problem cited was related to manufacturing at a third-party facility. Regulators did not raise any concerns about the drug’s safety or effectiveness.
The company fixed the manufacturing issue and resubmitted its application in late 2025. The FDA accepted the new filing and has been reviewing it. The agency is expected to decide on the new application by June 29. If approved, the company will launch OLC in the third quarter.
Analyst Takeaways
H.C. Wainwright, which maintains a Buy rating and $22 price target on the stock, remains bullish on the upcoming decision and recommends taking advantage of any stock weakness prior to approval.
According to data from Koyfin, all ten analysts covering UNCY rate it ‘Buy’ or higher. The stock has a 12-month average price target of $41.30, representing a potential upside of about 400% from the stock’s last closing price.
How Did UNCY Retail Traders React?
On Stocktwits, retail sentiment around UNCY stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels. Over the past week, message volume rose 219%, according to Stocktwits data.
A Stocktwits user said that they are buying the dip.
Another user highlighted “high probability of success” for the stock.
UNCY stock has gained 21% year-to-date.
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