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!

Wall Street Loses Sleep Over Cephalon's Stay-Awake Pill

Mixed opinions from a Food and Drug Administration advisory committee on a stay-awake pill made by Cephalon (CEPH) are provoking a lot of tossing and turning on Wall Street.

The company's stock has been bouncing around ever since the panel's opinions were released Thursday just before markets closed. Analysts have been bouncing around, too, with many injecting uncertainty into their optimism. One indicator of how the FDA panel caused sleeplessness on Wall Street: Seven analysts filed Cephalon research notes between midnight and 6:30 a.m. Friday.

The subject of the swirling sentiment is Provigil, a Cephalon drug that is approved by the FDA for treating sleepiness associated with narcolepsy, a disease in which people can fall asleep in the daytime, any time. West Chester, Pa.-based Cephalon had asked the FDA to approve an expanded use of the drug.

Federal law allows doctors to prescribe a drug for anything as long as the FDA approves it for a single use. In the case of Provigil, Cephalon says only 11% of its sales come from treating narcolepsy.

Off-label uses include treating fatigue in depressed patients (38%) and in multiple sclerosis patients (12%). Provigil had sales of $196.3 million last year.

Federal law also prohibits companies from marketing drugs for any disease that isn't listed on the drug's label. That means Cephalon can only market Provigil to a small group of specialists -- neurologists, psychiatrists, sleep disorder experts -- who treat narcoleptics. There are 50,000 narcoleptics in the U.S.

But if Cephalon could convince the FDA to expand the number of diseases and conditions for Provigil, then Cephalon could reach the marketing goldmine -- general practitioners. Based on the FDA advisory committee's decision, Cephalon came away with some gold nuggets as well as some iron pyrite.

1 of 4

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 17,113.54 +61.81 0.36%
S&P 500 1,983.53 +9.90 0.50%
NASDAQ 4,456.0160 +31.3120 0.71%

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