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.

Bayer’s (BAYRY - Analyst Report) Healthcare unit recently received encouraging news from the US Food and Drug Administration (FDA) when the latter cleared the German company’s Stivarga (regorafenib) for an additional indication.

The US regulatory body recently approved Stivarga for the treatment of patients suffering from locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST). The patients were previously treated with Novartis’ (NVS - Snapshot Report) Gleevec (imatinib mesylate) and Pfizer Inc.’s (PFE - Analyst Report) Sutent (sunitinib malate).

Stivarga is already available in the US 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 FDA approval for the new indication was based on 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 Gleevec and Sutent. Stivarga’s label in the US carries a boxed warning citing the risk of hepatotoxicity.

Notably the FDA reviewed Bayer’s oncology drug on a priority basis. 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.

We expect the sales potential of Stivarga to be boosted further with the approval of the new indication (GIST). The good news came just before Bayer is gearing up for its fourth quarter announcement. Bayer will report its financial results for the fourth quarter and full year 2012 on Feb 28, 2013.

Bayer, a large cap pharma company, currently carries a Zacks Rank #2 (Buy). Another large cap pharma stock Eli Lilly and Company (LLY - Analyst Report) also carries a comparable rank.

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
CELL THERAPE CTIC 3.33 +11.37%
CANADIAN SOL CSIQ 29.64 +9.45%
LORUS THERAP LRUSF 0.50 +8.77%
ZIOPHARM ONC ZIOP 3.80 +8.26%
ENANTA PHARM ENTA 36.82 +7.38%