Unicycive Therapeutics Inc (NASDAQ:UNCY) saw its shares plunge 26% in early trading after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the company’s application for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in patients undergoing dialysis for chronic kidney disease.
According to the company, the FDA’s rejection was not due to any concerns with the safety, efficacy, or clinical data of OLC itself. Instead, the setback stemmed from issues identified at a third-party manufacturing partner. The regulatory agency cited manufacturing process deficiencies, but none were directly tied to Unicycive’s product.
In response, Unicycive said it plans to promptly request a Type A meeting with the FDA to chart a path forward. The company also indicated it has already engaged a second manufacturing vendor capable of producing the OLC drug product, which may address the concerns raised in the CRL related to Chemistry, Manufacturing, and Controls (CMC).
“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, CEO of Unicycive. “With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients.”
Unicycive also reassured investors about its financial footing, reporting an unaudited cash balance of roughly $20.7 million—sufficient, it says, to support operations into the second half of 2026.
The New Drug Application (NDA) for OLC was intended to offer a new option for managing elevated phosphate levels in dialysis patients, a common and serious complication of chronic kidney disease. Despite the CRL, Unicycive emphasized that the FDA raised no issues with the drug’s data package or its proposed usage.