This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Indevus Soars on Improved FDA Timeline

Indevus (IDEV) shares surged early Friday after the specialty pharmaceutical firm announced it had reached an agreement with regulators and would resubmit sooner than expected its application for its testosterone replacement therapy.

Shares of the Lexington, Mass.-based company were rising $1.39, or 80%, to $3.12 in recent trading.

Indevus said in June that the Food and Drug Administration would withhold approval and would require additional safety data on Nebido, a long-acting injectable testosterone.

Executives said a new clinical trial could be necessary to collect that safety data, estimating that it wouldn't be able to resubmit its application for at least 18 months. On Friday, the company said it now expects to use existing data and resubmit its application in the first quarter of 2009.

Given an estimated six-month FDA review time, assuming approval, Indevus said it will be in a position to launch the injection in the fourth quarter of 2009.

Indevus will fork over a database with safety information from more than 14,000 injections in more than 2,600 patients from existing trials in the U.S. as well as post-marketing studies in Europe. The FDA, according to the company, has said this database will suffice to determine the incidence of serious post-injection oil based reactions.

Biotech Select

The FDA's safety concerns related to a short-term adverse reaction to the injection that can cause patients to cough or suffer shortness of breath, according to the company. It was seen in one of 500 patients enrolled in the Indevus clinical trials.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG
AUXL $36.47 -0.16%
RPRX $9.85 1.44%
AAPL $126.41 -1.66%
FB $81.21 0.39%
GOOG $575.33 0.34%

Markets

DOW 18,135.72 +38.82 0.21%
S&P 500 2,101.04 +2.51 0.12%
NASDAQ 4,982.8090 +15.6680 0.32%

Partners Compare Online Brokers

Free Reports

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