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What: Shares of biopharma developer Amylin Pharmaceuticals
So what: Trading in Amylin shares was halted on Friday as the decision deadline approached, so this morning was the first opportunity that investors had to react in non-after-hours trading to the good news.
With the approval, Bydureon will be the first, once-per-week treatment for type 2 diabetes to hit the market. The FDA's thumbs-up follows an extended approval process, which included extra testing to address safety concerns. In the end, the FDA is requiring that the prescribing label for the drug include a warning about the fact that it caused certain types of thyroid tumors in rats.
Now what: For Amylin shareholders, the focus now turns to how the drug will be received by the market. The drug addresses a massive market in the U.S. and, at least from a perspective of convenience, the once-per-week formulation is a notable selling point. However, other drug manufacturers have hardly overlooked the diabetes market and so Bydureon faces, and will continue face, significant competition.
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Fool contributor Matt Koppenheffer does not have a financial interest in any of the companies mentioned. You can check out what Matt is keeping an eye on by visiting his CAPS portfolio, or you can follow Matt on Twitter @KoppTheFool or Facebook. The Fool's disclosure policy prefers dividends over a sharp stick in the eye.
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