Shares of Discovery Laboratories jumped to 18-month highs Wednesday after federal regulators approved its respiratory distress syndrome treatment.
THE SPARK: After the markets closed Tuesday, Discovery Labs said the Food and Drug Administration cleared the marketing of Surfaxin. The drug is designed to prevent respiratory distress syndrome in premature infants who are at high risk for developing that condition. Respiratory distress syndrome is a condition in which children are born without enough pulmonary surfactant, a substance produced by the lungs that is essential for breathing.
THE BIG PICTURE: The Warrington, Pa., company has had its first two products approved in 2012. On Feb. 2, the FDA approved Afectair, which is a device designed to deliver aerosolized drugs to patients who are on mechanical ventilation.
The FDA had been reviewing Surfaxin since 2006, but the drug was not approved because of manufacturing issues and concerns about its shelf life. An FDA advisory panel recommended approval on Feb. 1. Discovery Labs says it plans to start marketing Afectair and Surfaxin in late 2012.
SHARE ACTION: Shares of Discovery Laboratories rose 22 percent, or 83 cents, to $4.58 in midday trading. The stock is up 68 percent since Feb. 1.