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

Best And Worst FDA Drug Approval Stocks of 2013

Sucampo Pharmaceuticals (SCMP): FDA approval of Amitiza: 76%. Rejection: 24%.

Navidea Biopharmaceuticals (NAVB): FDA approval of Lymphoseek: 72%. Rejection: 28%.

Raptor Pharmaceuticals (RPTP): FDA approval of Procysbi: 81%. Rejection: 19%.

Aveo Pharmaceuticals: The bears growl again. Fifty-seven percent of respondents expect the FDA advisory panel to vote against Tivopath; 43% predict a positive vote. Aveo's argument that Nexavar crossover mucked up Tivopath's survival benefit doesn't appear to be persuasive to investor contestants.

Delcath Systems: Fifty-four percent predict the FDA panel will slap down Melblez; 46% say the panel will be positive. Close again, but leaning bearish. But check this out: 64% predict FDA will ultimately reject Melblez while 35% says it will be approved. Weird. Is it a fluke that more people predict Melblez's FDA rejection than a negative panel? That suggests a group of investors believe FDA will overturn a positive vote by the panel -- a relatively rare outcome.

Sure enough, there are 11 contestants -- almost 10% of the total entrants -- who are predicting a positive FDA panel for Melblez followed by an FDA rejection. Very interesting. If you're in this group and happen to read this column, drop me an email and explain your thinking.

Ziopharm Oncology: Another runaway, with 78% predicting positive results from the palifosfamide clinical trial versus just 22% believing the trial comes up negative. If everyone is so confident in a Ziopharm win, why doesn't the stock trade better going into the results announcement at the end of March?

For anyone interested, my personal picks are in line with consensus with the exception of United Therapeutics, where I predict FDA rejection of oral Remodulin.

I voted yes on Sarepta accelerated approval filing, no on Arena in Europe, a positive Titan panel, FDA approvals for A.P. Pharma, Biogen, Sucampo, Navidea and Raptor. I'm on the fence with Aveo's FDA panel but ultimately predicted a negative vote (just barely, I can see it going the other way, too.) I'm definitely negative on Delcath's FDA panel and the ultimate FDA approval decision. Finally, I'm also positive on Ziopharm.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
2 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
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
AVEO $0.87 -0.01%
ARNA $1.42 -3.70%
DCTH $0.26 -3.00%
SRPT $11.22 -0.66%
ZIOP $5.21 -3.20%


Chart of I:DJI
DOW 15,632.24 -282.50 -1.78%
S&P 500 1,825.47 -26.39 -1.43%
NASDAQ 4,237.9050 -45.6870 -1.07%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs