完整回复信后，Uniycive股价下跌25%

2025-06-30 23:04

Unicycive Therapeutics (NASDAQ:UNCY) is down ~25% after disclosing it has received a Complete Response Letter from the U.S. FDA for its application for oxylanthanum carbonate.
The candidate aims to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.
Unicycive said that the FDA highlighted deficiencies at a third-party manufacturer related to its contract development and manufacturing organization, which were previously identified.
The company said the agency's concerns are unrelated to the drug itself or data supporting it.
Unicycive said it is seeking a Type A meeting with the FDA to resolve the issues.
An alternate third-party manufacturer that has already manufactured oxylanthanum carbonate was identified as part of its manufacturing strategy, according to Unicycive, and "could also be used to support the resolution of the [chemistry, manufacturing, and controls] issues identified in the CRL."

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