Shares of Discovery Laboratories took a nasty hit this morning after it announced that the FDA was asking for more data on Surfaxin, an experimental respiratory drug for infants. The agency's second approvable letter asked for more data on the drug's chemistry, manufacturing and controls for the product. Surfaxin mimics lung surfactants, which play a role in breathing. Discovery says it is setting up a meeting with the FDA to discuss the letter.
"Our top priority is to satisfy the FDA's requests as soon as possible, so that we can obtain final approval for this important life-saving therapy and make it available to the neonatal community," said Robert J. Capetola, Discovery's president and CEO. "In light of today's news, we are analyzing all aspects of our business with an intention to conserve cash while remaining focused on developing our NICU (neonatal intensive care unit) franchise."
- read the report from the Philadelphia Business Journal