discovery labs

Discovery Laboratories, Inc. (Nasdaq: DSCO) 6.4% HIGHER; announces today that it has received written guidance from the U.S.

FDA that is consistent with its ongoing, comprehensive preclinical program to resolve the sole remaining chemistry, manufacturing & control issue necessary to potentially gain FDA marketing approval for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome in premature infants.

The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a Phase 3 clinical program.

Discovery Laboratories (Nasdaq: DSCO) 47% LOWER; 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.

Navisite (Nasdaq: NAVI) 20% HIGHER; bouncing after recent weakness.

Discovery Laboratories (Nasdaq: DSCO) 53% LOWER; 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. Lear Corporation (NYSE: LEA) 22% LOWER; NYSE Regulation has determined that the common stock of Lear Corporation (NYSE: LEA) should be suspended immediately, saying it is no longer suitable for listing on its planned Chapter 11 filing.