Unicycive Resubmits NDA for Oxylanthanum Carbonate and Appoints New Director

Unicycive Therapeutics, Inc. announced on September 29, 2026, that it has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for patients with chronic kidney disease (CKD) on dialysis. The resubmission package includes Chemistry, Manufacturing, and Controls (CMC) data from a new third-party drug product manufacturing vendor. The new vendor’s facility was inspected by the FDA in March 2024 and received a "No Action Indicated" status, indicating compliance with current Good Manufacturing Practices (cGMP). The package includes 12 months of stability data from the new vendor and additional in-vitro bridging data between the two vendors.

The company anticipates the FDA will accept the resubmission within 30 days, with a new Prescription Drug User Fee Act (PDUFA) date expected six months from the resubmission. This follows a Complete Response Letter (CRL) received in June 2026, which cited deficiencies at the original third-party manufacturing vendor. The FDA did not raise concerns regarding clinical efficacy or safety data. Unicycive intends to maintain both drug product vendors to ensure supply chain redundancy. If the original vendor is inspected favorably in the near term, the company plans to seek FDA alignment on a shorter approval timeline.

Separately, Unicycive reported that as of June 30, 2026, its unaudited cash, cash equivalents, and marketable securities totaled $61.4 million. The company states this cash position supports continued commercial launch preparation and an expected runway into the second half of 2027. Additionally, the company announced the appointment of Meredith S. Manning as an independent director, effective October 1, 2026. Ms. Manning will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees, and will chair the Nominating and Corporate Governance Committee. She brings over 25 years of global biopharmaceutical experience, including her recent tenure as Chief Commercial Officer of Soleno Therapeutics, Inc.