Unicycive Therapeutics (UNCY) stock suffered a major setback on Tuesday due to an update from the Food and Drug Administration (FDA). The agency found deficiencies at one of the clinical-stage biopharmaceutical company’s third-party manufacturing vendors.
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Due to these deficiencies, the FDA has precluded any label discussions surrounding a New Drug Application for oxylanthanum carbonate. This is the company’s treatment for hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive Therapeutics expects a final decision from the FDA by June 28, 2025.
UNCY stock dropped 35.56% alongside today’s news and is down 31.65% year-to-date. Despite this, the shares are still up 37.4% over the past 12 months.
Is Unicycive Therapeutics Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Unicycive Therapeutics is Strong Buy, based on six Buy ratings over the last three months. With that comes an average UNCY stock price target of $6.67, representing a potential 1,012.04% upside for the shares.
