This Day On The Street
Continue to site
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

Four Drug Stocks Facing FDA Approval Decisions in July

BOSTON ( TheStreet) -- Four FDA drug approval decisions in July -- headlined by another weight-loss drug and a prescription fish oil pill with blockbuster potential -- will keep biotech investors busy in what is normally one of the sector's slower months.

Vivus (VVUS - Get Report) is expected to learn the fate of its weight-loss pill Qnexa on Tues. July 17. Recall, FDA was supposed to rule on Qnexa in April but delayed the decision by three months in order to review a risk management plan ensuring safer use of the drug.

Shares of Vivus are up 24% since the company announced the Qnexa regulatory delay in early April, largely because investors interpreted it as a vote of confidence in the drug's eventual approval.

Seventy-seven percent of contestants in TheStreet's Summer FDA Drug Approval Contest predict Qnexa's full approval on July 17 against 19% predicting the drug's rejection. Another 5% believe FDA will delay its decision again. The positive sentiment towards Vivus in the contest is much higher than it was for Arena Pharmaceuticals (ARNA - Get Report) and its weight-loss drug Belviq. FDA approved Belviq, of course.

Qnexa helped patients lose more weight than Belviq (comparing across different phase III trials) but Qnexa also causes more side effects. While Qnexa is widely expected to receive FDA approval on July 17, what remains a mystery still is how regulators will restrict the drug's use in order to mitigate side effects and risks, most notably the potential for birth defects in babies born to women who take Qnexa while pregnant.

Investors also wait to see how quickly Vivus can launch Qnexa after approval. With Arena and its marketing partner Eisai stuck in neutral and unable to launch Belviq until early next year, Vivus could become the first new weight-loss drug to become available for obese Americans despite being approved second.

Amarin (AMRN) probably has the most highly anticipated date with FDA on Thursday July 26, as regulators decide on the approval of the company's prescription fish-oil pill AMR101 for the treatment of patients with very high levels of triglycerides. As with Qnexa, investor expectations for AMR101 are ultra-bullish: 76% of contestants in TheStreet's drug-approval contest forecast full approval versus just 5% predicting rejection. Another 19% believe FDA will delay its decision. Confidence in AMR101's approval is bolstered by strongly positive results from the phase III "MARINE" trial and the decision by FDA not to bring the drug in front an outside advisory panel.

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
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
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
SYM TRADE IT LAST %CHG
ONXX $0.00 0.00%
AMRN $1.95 0.00%
ARNA $4.01 0.00%
HZNP $32.57 0.00%
VVUS $2.53 0.00%

Markets

DOW 18,162.99 +121.45 0.67%
S&P 500 2,123.48 +19.28 0.92%
NASDAQ 5,106.5930 +73.8420 1.47%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs