Discovery Laboratories Inc. shares jumped in premarket trading Friday after the drug developer said regulators agreed to updated product specifications for its respiratory drug Surfaxin and that it has begun making the drug.
The Warrington, Pa., company's stock had plunged in April, when it said the drug's launch would be delayed until the fourth quarter after the Food and Drug Administration asked for more information about the way it documents Surfaxin product specifications and a new analytical chemistry method.
Shares jumped Friday after Discovery said the FDA agreed to the specifications. The company has started making the drug for planned commercial introduction this quarter.
The FDA approved Surfaxin in March 2012. At the time, Discovery Labs said it would start marketing the drug during the fourth quarter of the year. Last October, the company said it had to update product specifications and one of the ways it measured the performance of Surfaxin. It said then that that would delay the launch of Surfaxin until the second quarter of 2013.
Surfaxin is intended to prevent a condition called respiratory distress syndrome in premature infants. Respiratory distress syndrome occurs when children are born without enough pulmonary surfactant, a substance produced by the lungs that is essential for breathing. The condition is often treated with mechanical ventilation and animal-derived surfactant replacements.
The company's stock jumped 49 percent, or 96 cents, to $2.93 in premarket trading after rising as high as $3.48 earlier. That tops the highest price the shares have seen during regular trading hours in more than a year.
- Health Care Industry
- product specifications