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Investing.com -- Unicycive Therapeutics Inc (NASDAQ:UNCY) stock fell 26% after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Oxylanthanum Carbonate (OLC) treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.
The FDA cited deficiencies at a third-party manufacturing vendor that were unrelated to OLC itself. The regulatory agency did not raise concerns about pre-clinical, clinical, or safety data in its response.
Unicycive plans to immediately request a Type A meeting with the FDA to align on next steps. The company noted it has already identified a second manufacturing vendor that has produced OLC drug product, which could help resolve the Clinical Manufacturing and Controls issues identified in the CRL.
"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."
The clinical-stage biotechnology company reported an unaudited cash balance of approximately $20.7 million, which it expects will provide runway into the second half of 2026.
Unicycive had submitted the New Drug Application for OLC to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The company emphasized that the FDA has not highlighted any other technical concerns related to the submitted documentation or testing of OLC itself.
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