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Unicycive Therapeutics (Nasdaq: UNCY) announced that the FDA has accepted 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 FDA deemed the resubmission a Class II complete response, resulting in a six-month review period, and assigned a PDUFA target action date of June 29, 2026. Unicycive Therapeutics is a B2i
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Unicycive Therapeutics (Nasdaq: UNCY) announced Q3 2025 results and remains on track to resubmit its NDA for oxylanthanum carbonate (OLC) by year-end. Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/unicycive. The company reported solid progress on multiple fronts, including resolution of FDA manufacturing concerns, presentation of compelling pill burden reduction data at ASN Kidney Week 2025, and a strengthened balance sheet w
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