UNCY Stock Rallies 8% As Retail Traders Anticipate FDA Clearance For Lead Drug Candidate

• A decision is expected by Monday. 
• On Stocktwits, retail sentiment around UNCY stayed within the ‘extremely bullish’ territory over the past 24 hours. 
• Over the past 24 hours, retail chatter around the stock rose 433%, according to Stocktwits data.

Shares of Unicyive Therapeutics (UNCY) gained 8% on Monday after a steep 13% fall on Friday as investors gear up for the Food and Drug Administration’s decision on its lead drug.  

Unicyive 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. A decision is expected by today.

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 ‘extremely high’ levels. Over the past 24 hours, retail chatter around the stock rose 433%, according to Stocktwits data.

A Stocktwits user expects the FDA decision after hours and voiced hopes for an approval pushing the stock up to $12 on Tuesday.  

Another voiced hopes for the stock more than doubling on a possible approval.

A third user said that the price action hints towards “high confience” in approval. “I have been following PDUFAs for 2 years now and it's quite rare to see rally on the date itself before approval,” they wrote.

UNCY’s Previous Rejections

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

Last week, H.C. Wainwright, which maintains a Buy rating and $22 price target on the stock, reiterated bullishness on the upcoming decision and recommended 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 479% from the stock’s last closing price.

UNCY stock has gained 33% year-to-date.

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