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

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For Immediate Release
 
Chicago, IL – March 27, 2014 – 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 (GILD-Free Report), Amgen (AMGN-Free Report), Endocyte (ECYT-Free Report), Celgene (CELG-Free Report)  and Biogen (BIIB-Free Report) .
 
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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 (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 (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 (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 (SMDCY) platform. Shares were up a whopping 92.4%.

FDA Approves Celgene (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 (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.

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