Unicycive tumbles as FDA rejects kidney disease drug over manufacturing issues
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%
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