Back to top

Analyst Blog

Pipeline updates are eagerly awaited by investors in the biotech/pharma space. An insight into late-stage candidates (including regulatory approval) targeting lucrative markets often influence their investment decisions on a particular stock.

Last week, GlaxoSmithKline (GSK - Analyst Report) announced that its Tafinlar-Mekinist combination has been approved by the U.S. Food and Drug Administration (FDA). The FDA approved Tafinlar plus Mekinist for BRAF V600 E or K mutation-positive unresectable or metastatic melanoma.

FDA approval came on the basis of data from a phase I/II study evaluating Tafinlar plus Mekinist versus Tafinlar alone in patients suffering from BRAF V600E or K mutation positive metastatic melanoma. The combination showed an impressive overall response rate/ORR (76%) and a median duration of response (10.5 months) as compared to Tafinlar alone (ORR 54%, median duration of response 5.6 months).

We remind investors that both drugs, Tafinlar and Mekinist, were approved as monotherapy in the U.S. for melanoma, last year.

In the third quarter of 2013, Tafinlar ($4 million) and Mekinist ($3 million) generated combined sales of $7 million. Currently approved melanoma drugs include Roche’s (RHHBY - Analyst Report) Zelboraf and Bristol-Myers Squibb Co.’s (BMY - Analyst Report) Yervoy.

Glaxo carries a Zacks Rank #3 (Hold). We are concerned about the loss of revenues in the third quarter due to investigation in China regarding fraudulent behavior and ethical misconduct. We are also disappointed with pipeline setbacks for two late stage candidates (drisapersen and darapladib). Moreover, Glaxo continues to face challenges in the form of EU pricing pressure and generic competition. We expect recent approvals, restructuring and cost-cutting efforts to offset some of the negatives.

Some better-ranked stocks include Allergan (AGN - Analyst Report) carrying a Zacks Rank #2 (Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

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 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
PLANAR SYST… PLNR 4.44 +5.21%
BITAUTO HOL… BITA 81.71 +5.12%
CTPARTNERS… CTP 16.66 +4.26%
CHINA BIOLO… CBPO 47.91 +3.30%
MALLINCKROD… MNK 72.94 +2.85%