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.

The US Food and Drug Administration (FDA) recently accepted Biogen Idec’s (BIIB - Analyst Report) Biologics License Application (BLA) for its hemophilia A candidate, Eloctate (recombinant factor VIII Fc fusion protein).

Biogen had submitted the BLA in Mar 2013. The regulatory filing was based on results from the A-LONG study. FDA approval for Eloctate would represent a significant advancement in hemophilia A treatment in more than two decades. The FDA has granted standard review which means a response regarding the approval status of Eloctate should be out early next year.

We note that Biogen’s hemophilia B candidate, Alprolix, is also under FDA review. With the FDA granting standard review, a response from the agency regarding the approval status of Alprolix should be out in the fourth quarter of this year.

A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Eloctate and Alprolix capture share from existing products in the hemophilia market. According to Biogen, Eloctate has the potential to reduce the number of intravenous injections by 50 to 100 per year in patients currently on preventive treatment.

Our Take

We are pleased with the pipeline progress at Biogen. The company received a major boost in late March with the FDA approval of its oral multiple sclerosis drug, Tecfidera. We expect Tecfidera to gain EU approval shortly - the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the approval of Tecfidera in Mar 2013.

Biogen currently carries a Zacks Rank #3 (Hold). At present, companies like Anika Therapeutics Inc. , Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) and Alkermes (ALKS - Analyst Report) look well-positioned. While Anika is a Zacks Rank #1 (Strong Buy) stock, Alkermes and Alexion are Zacks Rank #2 (Buy) stocks.
 

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
BITAUTO HOLD BITA 35.33 +14.82%
ANI PHARMACE ANIP 24.79 +14.66%
E HOUSECHINA EJ 10.99 +9.24%
CANADIAN SOL CSIQ 26.97 +7.15%
INTERNATIONA ICAGY 33.30 +5.38%