Unicycive tumbles as FDA rejects kidney disease drug over manufacturing issues

Unicycive Therapeutics

30/06/2025 12:39

** Shares of drug developer Unicycive Therapeutics UNCY.O fall 30% to $4.74 premarket

** The US FDA declined to approve UNCY's kidney disease drug, oxylanthanum carbonate, citing manufacturing issues at a third-party vendor

** The health regulator flagged the issue on June 10, which caused co's stock to drop over 40%

** Co was seeking the FDA's nod to use the drug as a treatment for hyperphosphatemia, a condition of high phosphate levels in patients on dialysis

** FDA found no problems with the drug's safety data, clinical studies, or the drug itself - UNCY

** Co says it has already identified a backup manufacturing vendor that has successfully produced the drug and has a good regulatory track record

** Co has about $20.7 mln in cash, which should last them into the H2 2026

** As of last close, stock down 14.4%

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))