Keryx Treatment Gets Special FDA Status

NEW YORK (AP) — Keryx Biopharmaceuticals Inc. said Wednesday the Food and Drug Administration gave its developing multiple myeloma drug KRX-0401, or Perifosine, orphan drug status.

Orphan drug status is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.

The company said a late-stage study is expected to start by the end of 2009.

Shares of Keryx surged 61 cents, or 39.1 percent, to $2.17 in afternoon trading. Earlier, the stock soared as much as 68.6 percent to a new 52-week high of $2.63.

Shares are still recovering from a devastating plunge in March 2008 following the failed late-stage study of the company's diabetes drug candidate Sulonex.