UNCY Stock Clocks Worst Day In A Year — Analysts Keep Buy Ratings Despite ‘5-12 Month Delay’ In Drug Approval

• The company was seeking approval for the drug to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. 
• Both B. Riley and H.C. Wainwright kept their ‘Buy’ ratings on the stock following the FDA rejection. 
• Unicycive said that it is in active engagement with the FDA.

Shares of Unicycive Therapeutics Inc. (UNCY) clocked their worst day in over a year on Tuesday after the company announced that the U.S. Food and Drug Administration has again refused to approve its drug oxylanthanum carbonate (OLC), sparking mixed reactions from Wall Street.

UNCY stock closed down 39% and fell a further 9% after-hours.

Analysts Maintain 'Buy' Ratings Despite Delays

B. Riley maintained its ‘Buy’ rating and $22 price target on the stock. The firm noted that the FDA’s rejection relates solely to third-party manufacturing issues rather than clinical safety or efficacy, with no additional data requests. While delayed, overall commercial opportunity and cash runway remain unchanged, the analyst stated.

H.C. Wainwright, meanwhile, lowered its price target to $15 from $22 while keeping a ‘Buy’ rating. The firm sees potential launch delays of 5-12 months, but also emphasized that the FDA raised no new concerns on clinical efficacy or safety.

FDA Issues UNCY Second Rejection

Unicycive said on Tuesday that the FDA refused approval for OLC to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, citing the same third-party manufacturing deficiencies identified in the prior rejection letter issued in June 2025.

“The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from Unicycive,” the company said. It added that the application had been resubmitted based on continued progress by the vendor in resolving deficiencies identified last year. The agency has not yet inspected the third-party vendor as part of the resubmitted application review, it noted.

“We remain confident in the efficacy and safety of OLC. We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA,” CEO Shalabh Gupta said.

How Did UNCY Retail Traders React?

On Stocktwits, retail sentiment around UNCY stock stayed in the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.

A Stocktwits user voiced optimism for the drug getting approved eventually in a few months.

Another user voiced frustration with the company’s management.

A third user said that the market “overreacted.”

UNCY stock has lost 19% year–date. 

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