This Day On The Street
Continue to site
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

21 Drugs Facing FDA Approval Decisions

Human Genome Sciences (HGSI)

Drug/indication: Zalbin for hepatitis C

Approval decision date: Oct. 4, 2010

Recent stock performance: At just under $30, the stock has rebounded 35% off its July low but is still just flat for the year.

In June, Human Genome Sciences said approval of Zalbin was unlikely after the FDA expressed concerns about the risk-benefit of the drug. Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons require once-weekly dosing.

Alexza Pharmaceuticals (ALXA)

Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder

Approval decision date: Oct. 11, 2010

Recent stock performance: At around $3, stock is still far from the 52-week high of nearly $4 reached in May.

AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail (BVF) will market AZ-004 in the U.S. and Canada, if approved.

Jazz Pharmaceuticals (JAZZ)

Drug/indication: JZP-6 for fibromyalgia

Approval decision date: Oct. 11, 2010

Recent stock performance: Shares tumbled to around $8.50 from more than $10 after the negative FDA advisory panel vote.

On July 20, an FDA advisory panel voted against approval of JZP-6 due to unacceptable risks of the drug being misused and potentially abused. JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
3 of 7

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
Only $9.95
14-Days Free
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
CADX $0.00 0.00%
AMGN $157.29 -2.00%
BMY $72.07 -0.26%
CPIX $4.72 -0.21%
OREX $0.45 -3.50%


Chart of I:DJI
DOW 17,701.94 -128.82 -0.72%
S&P 500 2,055.32 -20.49 -0.99%
NASDAQ 4,751.4360 -53.8550 -1.12%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs