Unicycive resubmits kidney-drug application with new manufacturer data
Unicycive ($UNCY) resubmitted its US application for oxylanthanum carbonate, an investigational oral phosphate binder for dialysis patients with chronic kidney disease. The package includes manufacturing and quality data from a new third-party supplier, twelve months of product-stability results and laboratory bridging data comparing the new and previous suppliers. The filing seeks to address the manufacturing issues affecting the program. The company expects the FDA to determine acceptance with
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