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The Zacks Analyst Blog Highlights: Synergy Pharmaceuticals, Amgen, Valeant Pharmaceuticals International, Celgene and Lexicon Pharmaceuticals

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For Immediate Release

Chicago, IL - February 01, 2017 - 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 Synergy Pharmaceuticals Inc. (NASDAQ: SGYP - Free Report ), Amgen Inc.(NASDAQ: AMGN - Free Report) , Valeant Pharmaceuticals International, Inc.(NYSE: VRX - Free Report),Celgene Corporation(NASDAQ: CELG - Free Report) and Lexicon Pharmaceuticals, Inc.(NASDAQ: LXRX - Free Report) .

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

Here are highlights from Tuesday's Analyst Blog:

4 FDA Decisions to Watch Out for in February 2017

Last year, there was a notable dip in FDA novel drug approvals with the agency giving its nod to 22 treatments, well below the 45 approvals in 2015 and 41 in 2014. So far in 2017, only one drug has gained approval -- Synergy Pharmaceuticals Inc.'s (NASDAQ: SGYP - Free Report ) Trulance for the treatment of chronic idiopathic constipation (CIC) in adults (Read more: Synergy Trulance Wins FDA Approval for Constipation ).

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance -- companies which hit the bull's eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.

Here is a look at important regulatory events scheduled for the month of February.

First up is biotech major, Amgen Inc.'s(NASDAQ: AMGN - Free Report) Parsabiv. Parsabiv, which gained EU approval in Nov 2016, got a complete response letter from the FDA in Aug 2016 for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis. Amgen's resubmitted regulatory application is under review with a decision from the FDA expected on Feb 9. According to information provided by Amgen, sHPT, a chronic and serious condition, affects many of the approximately 2 million people across the world who are receiving dialysis, including 468,000 people in the U.S. Amgen, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company's shares gaining 1.1% compared to the industry decline of 7.8%.

On Feb 16, 2017, the FDA is expected to issue a response regarding the approval status of Valeant Pharmaceuticals International, Inc.'s(NYSE: VRX - Free Report) investigational psoriasis treatment, brodalumab. Approval would allow the company to schedule a launch in the second quarter in the psoriasis market which is estimated to be worth about $10 billion. Valeant has had a rough time finding itself in the midst of the drug pricing controversy -- over the last one year, the Zacks Rank #5 (Strong Sell) stock has underperformed the Zacks categorized Medical-Drugs industry with shares declining 86.1% during this period compared to the industry decline of 10.1%. Brodalumab's approval would boost investor confidence in the company which is currently divesting non-core assets.

Celgene Corporation(NASDAQ: CELG - Free Report) is looking to expand the label of its key revenue generator, blood cancer drug Revlimid, which is currently under review for use as maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM) after receiving an autologous stem-cell transplant (ASCT). A decision from the FDA is expected on Feb 24. Label expansion into this indication will be a significant driver of Revlimid sales. Revlimid brought in sales of $6.9 billion in 2016 and Celgene is guiding towards 2017 sales in the range of $8 - $8.3 billion. Celgene, a Zacks Rank #3 stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company's shares gaining 12.3%. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Lexicon Pharmaceuticals, Inc.(NASDAQ: LXRX - Free Report) also has a big day coming up with the FDA expected to decide on the approval status of telotristat ethyl for the treatment of carcinoid syndrome on Feb 28.

The FDA was earlier expected to respond on Nov 30, 2016 but the PDUFA date was extended by three months as the agency needed more time to review additional clinical data analyses that had been submitted at the agency's request. With telotristat ethyl being its most advanced pipeline candidate, approval would be a major boost for Lexicon. We note that over the last one year, Lexicon has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company's shares rising 33.2% during this period.

Zacks' Top 10 Stocks for 2017

In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?

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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.

Strong Stocks that Should Be in the News

Many are little publicized and fly under the Wall Street radar. They're virtually unknown to the general public. Yet today's 220 Zacks Rank #1 "Strong Buys" were generated by the stock-picking system that has nearly tripled the market from 1988 through 2015. Its average gain has been a stellar +26% per year. See these high-potential stocks free >>.

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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 https://www.zacks.com/performance for information about the performance numbers displayed in this press release.

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Synergy Pharmaceuticals, Inc. (SGYP): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Valeant Pharmaceuticals International, Inc. (VRX): Free Stock Analysis Report

Celgene Corporation (CELG): Free Stock Analysis Report

Lexicon Pharmaceuticals, Inc. (LXRX): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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