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 This material may not be published, broadcast, rewritten or redistributed.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:
Retype 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
You May Also Like

James Foley's Family: Pope's Call Comforted Us

Friday, 22 Aug 2014 12:19 PM

The parents of slain American journalist James Foley said a call from Pope Francis gave the family great comfort followi . . .

Yellen: Fed Sees 'Significant' Under-Use of Labor Resources

Friday, 22 Aug 2014 10:22 AM

Federal Reserve Chair Janet Yellen said slack remains in the U.S. labor market even after gains made during the five yea . . .

Russia Convoy Enters Ukraine Without Kiev's Consent

Friday, 22 Aug 2014 10:17 AM

Russia's decision to send a convoy of aid trucks across the border into eastern Ukraine without Kiev's consent or an esc . . .

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