For Immediate Release
Chicago, IL – November 1, 2012 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Bayer (BAYRY), Novartis (NVS), Pfizer (PFE), Onyx Pharmaceuticals, Inc. (ONXX) and The Boeing Company (BA).
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Here are highlights from Wednesday’s Analyst Blog:
Priority FDA Review for Stivarga
Recently, the HealthCare unit of Bayer (BAYRY) 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) Gleevec and Pfizer’s (PFE) 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. (ONXX), 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.
We have an Outperform recommendation on Bayer. The stock carries a Zacks #2 Rank (Buy rating) in the short run.
Boeing Gets Multi-Billion MAX Order
Leading commercial airplane producer, The Boeing Company (BA) received a multi-billion order for its 737 MAX model from Aviation Capital Services LLC, a subsidiary of the State Corporation Russian Technologies (Rostech).
Rostech announced a commitment to purchase 35 737 MAX airplanes for Russia and the Commonwealth of Independent States (“CIS”). The order is valued at more than $3 billion at current list prices.
The 737 MAX is a new-engine variant of the world's best-selling airplane and builds on the strengths of today's Next-Generation 737. The 737 MAX incorporates the latest-technology CFM International LEAP-1B engines to deliver the highest efficiency, reliability and passenger comfort in the single-aisle market. As per Boeing, airlines operating the 737 MAX will see a 13% fuel-use improvement over today's most fuel efficient single-aisle airplanes and an 8% operating cost per seat advantage over tomorrow's competition. Boeing currently has 858 orders for the 737 MAX.
Aviation Capital Services LLC is one of the leading aircraft leasing companies in Russia and CIS.
Boeing enjoys a unique position as the largest aircraft manufacturer in the world in terms of revenues, orders and deliveries, and is also one of the largest aerospace and defense contractors. Besides, its revenues are spread across more than 90 countries around the globe.
Looking forward, Boeing recently taking into account its performance in the first nine months of 2012, raised its full year 2012 earnings per share guidance to a range of $4.80–$4.95 from its earlier guidance range of $4.40–$4.60. The company also raised its revenue guidance for 2012 to the range of $80.5 billion – $82 billion versus the earlier range of $79.5 billion–$81.5 billion.
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