Discovery Laboratories lost more than half of its stock value yesterday afternoon, plunging to 52 cents a share after investors got news of a new roadblock at the FDA for its respiratory drug Surfaxin.
After a four-year quest to gain an approval on the drug, Discovery Labs said that regulators had changed course in a meeting in early June, saying the developer had not offered enough data to gain an approval for the therapy - designed to treat respiratory distress in premature babies. And that would make it unlikely to get an approval with existing data. The FDA had declined to approve Surfaxin in April, but added that it felt it had supplied the agency with the necessary data to address its concerns.
"At the recent June 2 meeting," the company stated, "Discovery Labs learned that the FDA will now apply a newly defined standard to determine whether Discovery Labs has adequately demonstrated comparability of Surfaxin clinical to commercial drug product. This new standard represents a significant hurdle for approval of Surfaxin." The agency suggested that a new limited clinical trial would help its chances for gaining an approval.
In the short term Discovery Labs plans to focus on its other programs and will wait to further analyze a full record of its discussions with the agency before deciding on its next step.
- check out the report [1] from Dow Jones
- read the press release [2]
Links:
[1] http://online.wsj.com/article/BT-CO-20090701-715019.html
[2] http://www.discoverylabs.com/2009pr/070109-PR.pdf