Incyte Corp. (INCY) shares are down more than 5 percent on Friday morning trade after the company announced that the U.S. Food and Drug Administration or FDA has issued a complete response letter for ruxolitinib extended-release tablets, saying that it cannot approve the application in its present form. Ruxolitinib is a JAK1/JAK2 inhibitor for once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.
The FDA acknowledged that the New Drug Application met its objective of bioequivalence. Incyte said it intends to meet with the FDA to determine appropriate next steps.
Currently, shares are at $68.37, down 5.38 percent from the previous close of $72.26 on a volume of 1,013,034.
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