Discovery Labs shares sink, Surfaxin faces delay
NEW YORK -- Shares of Discovery Laboratories Inc. sank Wednesday after the drug developer said the availability of a new treatment for respiratory distress syndrome may be delayed until next year's second quarter.
THE SPARK: The Warrington, Pa., company said Wednesday that it must update its product specifications for Surfaxin after it learned that it has to improve an analytical chemistry method it uses to assess how the drug conforms to those specifications.
Discovery said it has started a plan to improve the method, and it will submit the updated specifications to the Food and Drug Administration. The company said that _ if the plan is successful _ Surfaxin's availability will be delayed until early in the second quarter.
The drug developer doesn't expect the delay to have a material impact on its business.
THE BACKGROUND: Surfaxin and the company's Afectair ventilator device both were approved early this year, and the company had planned to start marketing both in the fourth quarter. They treat respiratory distress syndrome, or RDS, a condition in which children are born without enough pulmonary surfactant, a substance produced by the lungs that is essential for breathing.
Discovery said Wednesday that it expects Afectair to be available by December.
SHARE ACTION: Down 14.6 percent, or 40 cents, to $2.33 in afternoon trading. The stock is still up more than 38 percent so far this year.