Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Arena Pharmaceuticals Inc. (ARNA - Snapshot Report) recently received ‘The Day 180 List of Outstanding Issues’ from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), in relation to its weight loss drug, Belviq. Arena’s shares were down significantly (almost 10%) on the news.

Arena needs to discuss the issues with the CHMP before the latter gives its final opinion on the marketing approval of Belviq. The issues are both non-clinical and clinical in nature, including tumors in rats, valvulopathy and psychiatric events. The company has been asked to justify Belviq’s overall risk-benefit profile after considering the above issues.

Arena had filed a Marketing Authorization Application (MAA) to the EMA for Belviq in Mar 2012. The company is looking to get the product approved as an adjunct to diet and exercise for weight control in overweight adults. The final opinion from the CHMP regarding Belviq is expected in the first half of this year.

We remind investors that another obesity drug, Vivus Inc.’s (VVUS - Snapshot Report) Qsiva, also received a negative opinion from the CHMP in Oct 2012. The CHMP rendered a negative opinion due to concerns over the potential cardiovascular and central nervous system effects associated with the long-term use, teratogenic potential and use by patients for whom Qsiva is not meant.

We expect investor focus to remain on the final opinion of the CHMP on EU approval of Belviq.

We currently have a Zacks Rank #2 (Buy) on the stock. Alkermes (ALKS - Analyst Report) and Medivation Inc. (MDVN - Analyst Report), carrying a Zacks Rank #1 (Strong Buy), currently appear to be more attractive in the pharma space.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GRP IN DXYN 15.84 +7.90%
BOFI HLDG IN BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%