Amylin Pharmaceuticals (AMLN) Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS) announced after the close Tuesday that the FDA issued a complete response letter regarding the New Drug Application for BYDUREON. The FDA requested a thorough QT study with exposures of exenatide higher than typical therapeutic levels of BYDUREON.
Amylin Pharmaceuticals gapped open dramatically lower Wednesday, but recovered some ground in the second half of the morning. Shares finished down by 9.46 at $11.03 on the highest volume of the year. The stock sank to an 11 1/2 month low.
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