Keryx Biopharma (KERX) Receives Orphan Drug Designation From the FDA

Shares of drug developer Keryx Biopharmaceuticals Inc. (KERX) spiked 17 percent to $4.18 for the biggest gain in the Russell 2000 Index. The co. said its experimental cancer drug, KRX-0401 (perifosine), received orphan drug designation from the U.S. Food and Drug Administration for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants.

The orphan drug status, which is reserved for novel therapies that are being developed to treat a rare disease or conditions that affect fewer than 200,000 patients the U.S., grants Keryx seven years of market exclusivity, upon approval.

Ron Bentsur, Chief Executive Officer of Keryx, said in a statement “We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma.”

Shares of Keryx were up 13.48 percent at $4.04 in late-morning trade Wednesday on Nasdaq.

Aeterna Zentaris Inc. (AEZS), the Canadian company that developed the drug and is Keryx’s partner, gained 10 percent to $1.22.

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