Back to top

Analyst Blog

Zacks Equity Research

BIIB's BG-12 Review Period Extended

ABT BIIB

 ZacksTrade Now

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.

Biogen Idec’s (BIIB - Analyst Report) shares  were down 2.74% after the company announced that the US Food and Drug Administration (FDA) has extended its review period for the company’s oral multiple sclerosis (MS) candidate, BG-12 (dimethyl fumarate), by three months.

The FDA said that it needs extra time to review the company’s New Drug Application (NDA) for BG-12. Biogen had submitted the NDA in March. The NDA was based on data from the phase III DEFINE and CONFIRM studies which showed that treatment with BG-12 led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.

The extension of the FDA’s review period means that a response regarding BG-12’s approvability should be out in March-April 2013 instead of later this year.  Importantly, the FDA did not ask for additional studies.

Biogen is the market leader in therapies for the treatment of MS. The company’s key products include Avonex and Tysabri. Biogen has been working on strengthening its position in the MS market. We believe BG-12 could become a leader in the oral MS market once launched. Biogen is also studying BG-12 as a combination therapy.

Meanwhile, Biogen and partner Abbott Labs (ABT - Analyst Report) moved another MS candidate, daclizumab, into a two-year phase III study (DECIDE) in July 2010, with results due in 2014. Daclizumab is being evaluated as a once-monthly or bi-weekly subcutaneous injection for relapsing-remitting MS. PEGylated interferon rounds up Biogen's late-stage MS pipeline. PEGylated interferon is currently in a phase III study (ADVANCE). Top-line results should be out in the first half of 2013.

We currently have a Neutral recommendation on Biogen, which carries a Zacks #3 Rank (short-term ‘Hold’ rating). Biogen has an important pipeline event coming up later this year with the company slated to report phase III results on rFVIIIFc (hemophilia A) from the A-LONG study.

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
KNIGHTSBRIDG VLCCF 13.95 +11.24%
QUESTCOR PHA QCOR 82.95 +3.60%
BIO PATH HOL BPTH 2.69 +3.46%
E*TRADE FINA ETFC 22.08 +2.70%
LAKE SHORE G LSG 0.79 +2.46%