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The Zacks Analyst Blog Highlights: Gilead, Amgen, Endocyte, Celgene and Biogen

Zacks Investment Research, Inc., www.zacks.com. (PRNewsFoto/Zacks Investment Research) (PRNewsFoto/ZACKS INVESTMENT RESEARCH)

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Zacks Investment Research, Inc.

Mar 27, 2014, 09:30 ET

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CHICAGO, March 27, 2014 /PRNewswire/ -- 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 the Gilead (Nasdaq: GILD-Free Report), Amgen (Nasdaq: AMGN-Free Report), Endocyte (Nasdaq: ECYT-Free Report), Celgene (Nasdaq: CELG-Free Report)  and Biogen (Nasdaq: BIIB-Free Report) .

Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.

Here are highlights from Wednesday's Analyst Blog:

Biogen Stock Roundup

There were quite a few updates last week from biotech companies, but all this was overshadowed by the biotech selloff at the end of the week. The biotech sector, which has had an incredibly good run over the last two years, tumbled on Friday with the trigger being a letter issued to Gilead (Nasdaq:GILD-Free Report) by lawmakers.

The letter basically questions Gilead's pricing of its recently approved hepatitis C virus (HCV) treatment, Sovaldi. The $84k price tag for a 12-week treatment period is considered too expensive and has come under heavy criticism. Gilead's shares were down 4.6%.

Sovaldi is a very important product in Gilead's portfolio and has multi-billion dollar sales potential. Gilead has until Apr 3 to submit a response to the letter. We believe Gilead will provide strong data supporting Sovaldi's efficacy as well as the cost.

Meanwhile, the selloff that started with the weakness in Gilead was fueled further by speculation about a biotech bubble. While NASDAQ Biotechnology was down 4.4%, the NYSE ARCA Biotech Index was down 3.9% on Friday.

Amgen (Nasdaq:AMGN-Free Report)Scores with Evolucumab… Again: Amgen shares were up about 2.9% on positive data on its PCSK9 inhibitor, evolocumab.

Evolocumab lowered bad cholesterol in patients suffering from homozygous familial hypercholesterolemia (HoFH), a rare genetic disease characterized by significantly high LDL-C levels which increase cardiovascular risk in these patients, who are mostly affected from an early age. These are the first phase III data on a PCSK9 Inhibitor in HoFH patients. PCSK9 inhibitors work by inhibiting PCSK9, a protein that reduces the liver's ability to remove "bad" cholesterol from the blood.

The race to bring the first PCSK9 inhibitor to market is heating up with several companies involved in the development of these drugs. But sometime back, the FDA had raised concerns about neurocognitive adverse events in the PCSK9 inhibitor class. These are events that are also associated with the use of statins. Amgen is looking to file for approval of evolocumab this year. The FDA will most likely ask all these companies to evaluate neurocognitive adverse events in long-term studies.

Endocyte (Nasdaq:ECYT-Free Report)Soars on Vynfinit News: Endocyte's investors had a lot to cheer about as the company provided two positive updates on its key experimental drug, Vynfinit. The first good news came from the EU with the experimental drug receiving a positive opinion regarding its conditional approval for a type of ovarian cancer.

Not just Vynfinit, a couple of companion imaging agents, Folcepri and Neocepri, which will help identify patients suitable for treatment with Vynfinit, also received a positive recommendation. So, Endocyte could well be looking at its first product approval in the coming months.

The second set of good news was positive data on Vynfinit from a mid-stage study on non-small cell lung cancer (NSCLC) patients. Both news validate the company's small molecule drug conjugates (SMDC) platform. Shares were up a whopping 92.4%.

FDA Approves Celgene (Nasdaq:CELG-Free Report)Blockbuster Hopeful: Celgene gained FDA approval for Otezla for the treatment of active psoriatic arthritis. With this approval, Otezla will be entering a market dominated by products like Humira, Enbrel, Remicade and Simponi among others. But Otezla comes with an edge as it is the first oral treatment to be approved for this indication.

That being said, the main potential of the drug is linked to the broader psoriasis indication – a response from the FDA should be out by September.

Biogen (Nasdaq:BIIB-Free Report)Faces Delay in Plegridy Approval Date: Biogen, well known for its strong presence in the multiple sclerosis (MS) market, is facing a delay in the approval process for its experimental MS drug, Plegridy. The FDA has extended the review period by three months. This means that a response from the FDA should now be out in the second half of the year instead of mid-14 as had been expected earlier.

The delay in Plegridy's approval date should not be a matter of major concern. The important thing is that the FDA has not asked for additional studies to be conducted.

Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.

About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today.

About Zacks

Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1978. The later formation of the Zacks Rank, a proprietary stock picking system; continues to outperform the market by nearly a 3 to 1 margin. The best way to unlock the profitable stock recommendations and market insights of Zacks Investment Research is through our free daily email newsletter; Profit from the Pros.  In short, it's your steady flow of Profitable ideas GUARANTEED to be worth your time! Register for your free subscription to Profit from the Pros.

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Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.

Media Contact
Zacks Investment Research
800-767-3771 ext. 9339
[email protected]
http://www.zacks.com

Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.

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SOURCE Zacks Investment Research, Inc.

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