Amylin Back to Drawing Table via FDA Denial (AMLN, ALKS, LLY)

October 20, 2010 · Filed Under Diabetes, fda 

Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) is getting pounded this morning.  Shares are effectively cut in half after the FDA declined to approve Bydureon as a potential diabetes drug with the request that it and partners need to do more testing..

The FDA requested a thorough QT study to analyze the effect on heart rates.  Also requested was the evaluation of the efficacy and the labeling of the safety and effectiveness.

Eli Lilly & Co. (NYSEL LLY) and Alkermes Inc. (NASDAQ: ALKS) plan to respond to the FDA request, however the release said “by the end of next year” and that this was pending FDA discussions.  The requirement for this additional data will requiring a six month review.

Amlylin’s Bydureon is the once a week injectable treatment of Byetta.

Amylin also gave preliminary data on revenues showing that revenues were approximately $154 million versus $192.9 million in the same quarter a year ago.

Amylin shares are down a whopping 48% at $10.65, under the 52-week trading range before of $11.01 to $24.21.  Eli Lilly is down 4.2% and Alkermes is down 23% at $11.05 in pre-market trading.



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