FDA postponed Amylin's drug approval

As predicted yesterday, Amylin held an Investor Conference Call this morning 5:30ET announcing the FDA's response to the company's request for commercializing Bydureon (see previous post on this drug). AMLN's stocks climbed this morning to $22.20 (9.58% jump from Friday's closing price), reflecting investor's confidence in the final approval of the drug. See AMLN's press release for details.

End-of-day recap
With the FDA's positive response to the NDA of Bydureon, stocks were trading up 0.22% ($36.01), 14.74% (to $14.01) and 15.99% (to$23.50) for Eli Lilly & Co., Alkermes, and Amylin, respectively, on the first day of the week. The greater leap for the latter two companies reflects the importance of Bydureon to their narrower portfolios, compared to the pharma giant, Lilly, emphasizing the magnitude of influence a single drug approval has on biotech firms. The agency will require no further preclinical or clinical data, but would like to see the finalization of the product labeling with associating Risk Evaluation and Mitigation Strategy (REMS). AMLN will also need to clarify existing manufacturing processes, likely as a result of questions related to the FDA's early problematic inspection of Amylin's Ohio manufacturing plant, where Bydureon will be produced. Nevertheless, the overall encouraging answer from the agency and the relatively swift timeline towards the eventual drug approval (several weeks for AMLN to address the issues and ~6 mo. for the FDA to make the final decision) are behind the bullish attitude of the stakeholders.

Interesting observation: Notice that the shot in stock prices for ALKS and AMLN (green shading) occurred almost at the exact same time around 12 - 1 pm ET? I suspect that this was due to those on the west coast catching up to the news around 9 am in the morning and frantically rushing in their orders, which helped raise the values. Too bad they were one step behind in grabbing those lower-priced shares!