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Unicycive Therapeutics Gets FDA's Complete Response Letter for Resubmitted Oxylanthanum Carbonate NDA

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Unicycive Therapeutics (UNCY) said Tuesday it has received US Food and Drug Administration's Complete Response Letter regarding a resubmitted new drug application for oxylanthanum carbonate for treating hyperphosphatemia in patients with chronic kidney disease on dialysis.

The letter is based on previously identified deficiencies at a third-party manufacturing vendor, the company said, adding that FDA has not yet conducted an inspection of that third-party vendor as part of its review process for the resubmitted application.

The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data has been requested from the company, Unicycive Therapeutics further said.

Shares of the company were down 50% in Tuesday premarket activity.

Price: $3.90, Change: $-3.80, Percent Change: -50.00%

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