Shares of Discovery Laboratories (DSCO) shot up 49 percent this morning after the Warrington, PA-based developer reported that the FDA termed its approach to resolving the agency's primary issue with its experimental drug Surfaxin as 'reasonable'--clearing the path to a potential approval. A consensus has been reached on the optimization and final method validation of its quality control and stability release test, says Discovery, along with a limited trial design for the respiratory distress syndrome therapy.
Over the past three years Discovery Labs has collected three approvable letters for Surfaxin, and each time has had to grapple with new demands from the FDA.
"This guidance provides a viable option for Surfaxin and meaningfully supports advancing our pipeline initiatives to potentially address a broad range of respiratory diseases such as RDS, acute respiratory failure, acute lung injury and cystic fibrosis," says CEO W. Thomas Amick. "We look forward to continued productive dialogue with the FDA."
- check out the Discovery Labs release
- read the story from the Philadelphia Business Journal