FDA needs more information on Discovery Labs' Surfaxin
WARRINGTON, Pa.—Discovery Laboratories Inc. said Friday the Food and Drug Administration has requested more information on the biotechnology company's premature infant respiratory distress syndrome drug Surfaxin, delaying its drug's approval.
Shares fell 90 cents, or 31 percent, to $2 in premarket electronic trading, having closed Thursday at $2.90.
The company had expected to receive a decision on approval Thursday. Late last evening, the regulatory agency issued an approvable letter outlining additional information requests, details of which the company didn't disclose in a statement.
A company spokesperson wasn't immediately available for comment early Friday.
Discovery Labs said previously it had finalized Surfaxin labeling discussions with the FDA, and the agency had completed its pre-approval inspection of the company's manufacturing facility in Totowa, N.J., and issued an Establishment Inspection Report (EIR) reflecting a successful inspection.
The company said it will contact the agency in the next few days to discuss next steps, and expects to update investors early next week.
Discovery Labs is developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Essential for breathing, surfactants are produced naturally in the lungs. Discovery Labs' technology produces a peptide-containing synthetic surfactant designed to mimic natural human lung surfactant. Surfaxin is its lead product candidate, and was developed to prevent respiratory distress syndrome in premature infants, as well as for other neonatal and pediatric indications.
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