This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Arena Pharma: FDA Panel Live Blog

SAN DIEGO ( TheStreet) -- Arena Pharmaceuticals (ARNA - Get Report) brings its weight-loss drug lorcaserin in front of an advisory committee of the U.S. Food and Drug Administration today.

Arena is trying to do what competitor Vivus failed to achieve in July -- convince a group of outside experts that the company has a weight-loss drug that is both effective and safe for the millions of obese Americans who can't seem to shed the pounds with diet and exercise alone.

In a review posted to the FDA's web site Tuesday, the agency's reviewers said lorcaserin provided only marginal weight loss for patients. The FDA also raised questions about the drug's safety and raised a concern about a potential cancer risk in animals.

The FDA's tough review spooked investors, sending Arena shares plunging. The stock closed Wednesday at $3.74, down 45% over the past two days.

Arena's stock will be halted today for the duration of the FDA advisory panel.

It's important to note that FDA drug reviews released ahead of advisory panel meetings are often sharply critical and sometimes do not accurately predict the ultimate vote of the panel's outside experts.

Arena's enters the fray of an FDA advisory panel amidst a regulatory environment obsessed with drug safety and (so far) unkind to obesity drugs. On Wednesday, eight experts siting on the same FDA advisory panel voted to withdraw Abbott Labs' (ABT - Get Report) weight-loss drug Meridia from the market, while another six panelists voted to restrict the drug's distribution. In July, a similar panel voted overwhelmingly against Vivus' drug Qnexa.

Arena will try to fight against this tide of skepticism over weight-loss drugs by citing lorcaserin's lack of serious side effects and two years of safety data showing patients are free from any additional cardiovascular safety problems. The company believes there is strong evidence to compel both the FDA and its advisory panel to support lorcaserin's approval. Next up, an FDA advisory panel will review Orexigen Therapeutics' (GSK) obesity drug Contrave in December.

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
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!

Markets

DOW 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

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