This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Exubera Getting More Review

Pfizer (PFE) said Friday that the Food and Drug Administration will need an extra three months to review its application for the inhaled insulin Exubera.

No explanation was given by Pfizer or its marketing partner Sanofi-Aventis (SNY).

The agency needs more time to review "additional technical chemistry data" from the companies. Pfizer and Sanofi-Aventis said they will "continue to work closely with the FDA so that this important medicine can be made available for patients."

Exubera is one of several inhaled insulin products in development, and it's far ahead of competitors in the regulatory review process. The FDA had been expected to act today.

Shares of both companies weren't affected. Pfizer's stock was up 16 cents to $21.26, while Sanofi-Aventis' stock was up 1 cent to $39.54.

However, shares of Nektar Therapeutics (NKTR), the company that developed the inhalation technology, dropped 45 cents, or 3.1%, to $14.31 in heavy trading. The stock dipped as low as $13.63.

"This appears to be a minor delay, with approval likely delayed to the end of January 2006," according to a research note from Sagient Research Systems of San Diego, whose BioMedTracker report analyzes biotechnology issues. "We continue to believe that the FDA will accept the advisory committee recommendations to approve Exubera for patients without underlying lung abnormalities."

Last month, an FDA advisory committee recommended approval of Exubera for treating adults with type 1 and type 2 diabetes. Type 1 diabetes is caused by the body's inability to produce insulin, the protein hormone that helps turn sugar into fuel for the body's cells. Type 2 diabetes, which is much more common, is caused by cells ignoring insulin or the body's failure to produce enough insulin.

The advisory panel vote was 7-2. Although the FDA isn't bound by panels' recommendations, it usually follows their advice.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,915.07 -70.54 -0.42%
S&P 500 1,964.68 -8.15 -0.41%
NASDAQ 4,396.2040 -22.83 -0.52%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs