Tags: US | Amylin | Mover

Amylin Rises as FDA Seeks Diabetes Drug Data

Monday, 15 Mar 2010 12:47 PM

 

Share:
  Comment  |
   Contact Us  |
  Print  
|  A   A  
  Copy Shortlink

Shares of Amylin Pharmaceuticals jumped 13 percent Monday as the Food and Drug Administration asked for more information on its potential diabetes treatment.

Amylin, along with partners Eli Lilly & Co. and Alkermes Inc., were not asked to conduct additional studies on the much anticipated drug exenatide LAR, or Bydureon. It is a once-weekly version of the twice-daily Byetta injection. The FDA request focuses on product labeling for Bydureon, along with risk mitigation and manufacturing information.

Amylin Pharmaceuticals Inc., based in San Diego, said it plans on responding to the FDA request within the next few weeks.

Company shares rose $2.59 to $22.85

Bydureon is part of the broader GLP-1 class of drugs, which work by increasing the body's insulin production.

The FDA approved Novo Nordisk's once-daily GLP-1 drug Victoza in January. That drug had been under review for two years as safety concerns slowed regulatory approval. The FDA did eventual give the go-ahead, with a warning about the risk of thyroid cancer.

On Friday, Jefferies & Co. analyst Thomas Wei said the FDA could eventually issue a similar warning for Bydureon, but that is priced into the stock.

"The risk-reward on Amylin remains attractive at current levels, given what we believe would be modest and short-lived downside risk on a complete response letter and significant upside on potential approval," he said, in a note to investors.

Barclays Capital analyst Dr. Jim Birchenough reaffirmed a "Overweight" rating on Monday, saying he expects a rapid response from Amylin and the complete response could support approval by June.

Meanwhile, shares Alkermes jumped rose $1.46, or 12 percent, to $13.67, after reaching a new 52-week high of $14.19. The company is providing the long-acting technology for Bydureon.

© Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Share:
  Comment  |
   Contact Us  |
  Print  
  Copy Shortlink
Around the Web
Join the Newsmax Community
Please review Community Guidelines before posting a comment.
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Country
Zip Code:
Privacy: We never share your email.
 
Hot Topics
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
Top Stories
You May Also Like

Arkansas Gun Range Is 'Muslim-Free Zone'

Tuesday, 30 Sep 2014 23:01 PM

The owner of an Arkansas gun range has banned Muslims from visiting her facility.
 . . .

John Boehner: 'Very Few' Republicans Will Oppose Me

Tuesday, 30 Sep 2014 22:18 PM

House Speaker John Boehner says he isn't worried about a conservative revolt that could oust him from his leadership pos . . .

White House: Secret Service Chief Won't Resign or Be Fired

Tuesday, 30 Sep 2014 22:20 PM

Amid the furor over a knife-wielding assailant who made it over the White House fence and into the president's residence . . .

Most Commented

Newsmax, Moneynews, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, NewsmaxWorld, NewsmaxHealth, are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved