Release - Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate - Channelchek

Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendorCompany anticipates FDA acceptance of the NDA…

Release - Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate - Channelchek

Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The Company anticipates Unit…

Unicycive Therapeutics resubmits OLC NDA to FDA

Unicycive's Sept. 29 FDA resubmission includes 12 months of stability data from a new manufacturer after two manufacturing-related letters.