Drug company Mallinckrodt Plc MNK, -1.81% confirmed Wednesday that the U.S. Food and Drug Administration has rejected its new drug application for stannsoporfin, a treatment for newborns who are at risk of developing severe jaundice. Mallinckrodt said it has received a Complete Response Letter from the FDA relating to stannsoporfin, which is being investigated for the treament of newborns with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia. The letter offers guidance on areas of further evaluation for resubmitting the NDA, said the company. "The letter from the FDA was not unexpected following the outcome at the recent Advisory Committee meeting," said Steven Romano, M.D., executive vice president and chief scientific officer. "We are evaluating the Agency's guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward." Shares fell 2.7% in premarket trade, but are up 59.4% in 2018, while the S&P 500 SPX, +0.04% has gained 7.1%.
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