Shares of Discovery Laboratories (DSCO) climbed this morning after the developer announced that it had been able to validate a test of the quality and stability of its lung drug Surfaxin. A little more than a year ago the agency rejected Surfaxin as a treatment for an infant respiratory ailment as it questioned its ability to check on the quality changes that could occur over the course of its shelf life.
"The successful optimization and revalidation of the BAT represents a key component of the comprehensive preclinical program," the Warrington, PA-based developer said in a statement. "Discovery Labs will now employ the optimized BAT in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of [respiratory distress syndrome]." Its shares climbed seven percent, to 53 cents, on the news.
The agency sent Discovery back to do preclinical work on the test and is promising feedback in June. If they're successful, Discovery Labs will be on track to file a complete response in early 2011.
- check out Discovery's release
- here's the Reuters story