This Day On The Street
Continue to site right-arrow
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!

FDA Caution Hits Spectrum Pharma

An advisory panel recommended that the Food and Drug Administration wait to decide on GPC Biotech's (GPCB) cancer drug Orplanta, news that sent Spectrum Pharmaceuticals (SPPI) plunging in after-market trading Tuesday.

Trading was halted for Munich, Germany-based GPC Biotech Tuesday while the advisory panel met to discuss its lead product candidate, prostate cancer drug Orplatna (satraplatin).

Spectrum Pharmaceuticals, which licensed the drug to GPC and has the option to co-promote it in the U.S., and Pharmion (PHRM), which has exclusive European rights to the drug, were negatively affected Friday by a brief released by the Oncology Drugs Advisory Committee that pre-empted this week's meeting.

The panel voted unanimously to recommend that the FDA wait for final survival data before making a decision on the approval of the product, which the company wants indicated for patients with prostate cancer that's no longer responding to prior chemotherapy and resists hormone treatments.

While the FDA, which is expected to make a decision on whether to clear the drug by mid-August, usually follows the recommendations of the panel, it's not bound to do so.

GPC previously thought it would be able to deliver the survival data before the end of this year but indicated today that the data may not be available until late 2008. The company will hold a conference call on Wednesday to discuss the panel's recommendations.

Shares of GPC were down 59 cents, or 2.8%, at $20.36, while they were halted Tuesday. Spectrum, which fell 9.4% throughout the day, plummeted another $1, or 20.8%, to $3.80 in after-market trading. And Pharmion, which closed the regular session down 4.2%, lost another $1.12, or 4.6%, to $23.50 in postmarket trading.

Select the service that is right for you!

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 17,300.38 +231.51 1.36%
S&P 500 1,995.26 +22.52 1.14%
NASDAQ 4,606.7080 +58.8740 1.29%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

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