June 30, 2026 08:55 AM EDT
PharmaFDA+Manufacturing
Unicycive gets second CRL for kidney drug as manufacturing woes continue
Anna Brown
News Reporter
Unicycive's CKD drug oxylanthanum carbonate gets a second FDA rejection over third-party manufacturing issues; shares drop ~50% premarket.
June 30, 2026 08:55 AM EDT
PharmaFDA+Manufacturing
Unicycive gets second CRL for kidney drug as manufacturing woes continue
Anna Brown
News Reporter

Unicycive Therapeutics ($UNCY) stock crashes over 46% as FDA rejects kidney disease drug NDA again over third-party manufacturing…

After Unicycive Therapeutics had its drug application for oxylanthanum carbonate (OLC)

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