Keryx Biopharmaceuticals says kidney disease drug won't be available until the fourth quarter; stock halted

Keryx Biopharmaceuticals Inc. shares were halted in pre-market trade Monday and the company said its kidney disease drug Auryxia wouldn't be available through about the fourth quarter, due to a production-related issue. The supply interruption, which the company said was "imminent," was caused by an issue converting active pharmaceutical ingredient, which is used to make a drug, into a finished drug product, which has resulted in variable finished drug yields. Keryx said that the production issues have eliminated its reserve of the drug. Auryxia first received Food and Drug Administration approval in late 2014, and the drug's net U.S. sales in the second-quarter were $8.3 million from about 13,000 prescriptions. Shares of the company rose 35.3% over the last three months, compared with a 5.2% rise in the S&P 500 .

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