Back to top

Analyst Blog

Recently, the HealthCare unit of Bayer (BAYRY - Analyst Report) announced that its oncology drug Stivarga (regorafenib) will be reviewed on a priority basis by the US Food and Drug Administration (FDA). Bayer is looking to get Stivarga, an oral multi-kinase inhibitor, approved for treating patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

We note that the US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases that do not have adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.

The new drug application (NDA), seeking approval of Stivarga for the GIST indication, was filed by Bayer in August 2012. The NDA was submitted on the basis of encouraging data from a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable GIST. The disease had progressed in the evaluated patients in spite of being previously treated with Novartis’ (NVS - Analyst Report) Gleevec and Pfizer’s (PFE - Analyst Report) Sutent.

We remind investors that Stivarga was approved in the US in September 2012 for treating patients suffering from metastatic colorectal cancer (mCRC), whose disease had progressed even after treatment with the standard drugs prescribed for the disease. The approval was based on encouraging data from a pivotal phase III study (CORRECT: n=760). Bayer and Onyx Pharmaceuticals, Inc. , as per an agreement inked last year, co-promote Stivarga in the US.

The sales potential of Stivarga would be further boosted if the FDA clears the drug for the GIST indication.

Our Recommendation

We have an Outperform recommendation on Bayer. The stock carries a Zacks #2 Rank (Buy rating) in the short run.

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
BITAUTO HOL… BITA 81.24 +4.52%
PLANAR SYST… PLNR 4.40 +4.27%
COGNEX CP CGNX 44.19 +2.74%
CHINA BIOLO… CBPO 47.65 +2.74%
GILEAD SCIE… GILD 104.78 +2.45%