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Unicycive tumbles as FDA flags manufacturing issues with kidney disease drug

ReutersJun 10, 2025 10:27 AM
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Shares of drug developer Unicycive Therapeutics UNCY.O fall 27% to 65 cents premarket

UNCY says U.S. FDA has identified manufacturing issues with third-party vendor of its kidney disease drug, oxylanthanum carbonate

Co says FDA cannot discuss drug labeling with UNCY until these issues are resolved

Adds it is working to resolve FDA's concerns and is confident in drug's potential to treat hyperphosphatemia, which is condition where there are high phosphate levels in patients on dialysis

Despite issues, final FDA decision is expected by original action date of June 28

As of last close, stock up 13.3% YTD

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