European regulators granted marketing approval for an injectable once-weekly diabetes drug, Bydureon, being developed by Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN) and Alkermes Inc. (ALKS).
The approval is a positive development for the companies, which are still hoping to get approval in the U.S. after a rejection of the drug last year.
Bydureon is a long-acting version of Byetta, a twice daily drug from Lilly and Amylin that was approved in 2005.
The FDA declined to approve Bydureon early last year and made the same move in October, requesting more clinical data. The companies expect to submit that data and re-apply for approval in the second half of the year.
Bydureon's success is key to the future of Amylin, which hasn't reported a profit since going public in 1992. The drug also would be a positive development for Lilly, which is seeking new drugs to offset looming generic competition to its top products.
Shares of Lilly and Alkermes closed Monday at $37.56 and $17.04, respectively. Amylin shares closed at $11.42. None of the stocks were active premarket.
-Thomas Gryta of Dow Jones Newswires contributed to this article.
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