Shares of Discovery Laboratories got a much needed boost after the developer announced plans for a sit-down with FDA regulators over the possibility that a limited trial could supply the agency with the data it would need to overcome its remaining primary concern regarding its respiratory drug surfaxin.
Back in April the company's shares went into freefall after the FDA spurned its latest marketing application for the therapy. The rejection came soon after auditors raised a going-concern alarm, and analysts were quick to note that a closed door at the FDA would keep potential partners away. Surfaxin was designed to treat respiratory distress syndrome in premature infants.
After the market closed on Thursday, though, Discovery Labs stock jumped 46 percent, to 69 cents, as investors keyed in on the possibility of a turnaround. Regulators and company officials will sit down on September 29, with a special focus on how Discovery Laboratories can demonstrate the comparability of the clinical drug and the manufactured product.
- check out the Discovery release
- read the story from Reuters