Unicycive Therapeutics, Inc. ( UNCY ) shares are trading lower Tuesday after the company announced update on its New Drug Application (NDA) for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.

The Details: The U.S. Food and Drug Administration (FDA) identified deficiencies in cGMP compliance at a third-party subcontractor of Unicycive's Contract Development and Manufacturing Organization, following an inspection. As a result, the FDA said any label discussions with the company are currently precluded.

Unicycive noted the issues do not involve its Drug Substance vendor and said it has responded to all FDA information requests. A final decision on the NDA is expected by the PDUFA action date of June 28.

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UNCY Price Action: At the time of writing, Unicycive shares are trading 33% lower at 60 cents, according to data from Benzinga Pro.

Image: This illustration was generated using artificial intelligence via Midjourney.