For Immediate Release
Chicago, IL – September 13, 2016 – 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 Spectrum Pharmaceuticals, Inc. (SPPI), Amgen Inc (NASDAQ:AMGN). (AMGN), AbbVie Inc. (ABBV) and Vertex Pharmaceuticals (NASDAQ:VRTX), Inc. ( VRTX).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Monday’s Analyst Blog:
3 Drug Stocks that Could Benefit from Key FDA Events This Month
The drug development process is often lengthy and time-consuming and requires the utilization of a lot of funds and resources. It may well take a drug anything between 10-12 years to be successfully developed and reach the market. In such a scenario, 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 three stocks that have important regulatory events scheduled for this month.
Spectrum Pharmaceuticals, Inc.’s (SPPI) new drug application for Qapzola (apaziquone) will be reviewed by an FDA advisory panel later this week. The FDA’s Oncologic Drugs Advisory Committee is meeting on Sep 14 to review the NDA - the proposed indication for the product is for the immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
Advisory panels provide the FDA with independent opinions and recommendations from outside experts on new drugs as well as FDA policies. While the agency is not required to do so, it usually follows the advisory committee's recommendation. Therefore, FDA advisory panel meetings are closely followed by investors as they give an insight into the FDA’s final decision regarding the approval status of the candidate. A positive panel recommendation would be a major boost for Spectrum, a Zacks Rank #3 (Hold) stock.
Next on the list is biotech major, Amgen Inc. (AMGN), which has an important regulatory event coming up later this month with the FDA expected to decide on the approval status of the company’s Biologics License Application (BLA) for ABP 501.
ABP 501 is a biosimilar candidate to AbbVie Inc (NYSE:ABBV).’s (ABBV) Humira, an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. With an FDA advisory panel voting in favor of ABP 501 earlier this year, expectations are high that the FDA will give its nod to ABP 501 on the target action date of Sep 25, 2016.
Why is this approval important for Amgen? Well, Amgen is pretty committed to the biosimilars effort and if approved, ABP 501 would be the first biosimilar from Amgen’s pipeline to gain approval. The Zacks Rank #3 stock has quite a few biosimilars in development including biosimilar versions of cancer drugs, Avastin and Herceptin. Amgen has even tied up with Japanese company, Daiichi Sankyo, to commercialize nine biosimilars in Japan.
Last year, on an analyst call, Amgen had said that it expects to launch five new biosimilars between 2017 and 2019. The biosimilars opportunity represents annual revenues of more than $3 billion for Amgen. Humira brought in 2015 sales of $8.4 billion in the U.S. alone where the composition of matter patent is expected to expire in Dec 2016.
But even if it gains FDA approval, Amgen will have to take a decision regarding its launch plans for ABP 501 considering AbbVie has initiated a patent infringement lawsuit against the company.
Third on the list is Vertex Pharmaceuticals, Inc. (VRTX), a company focused on cystic fibrosis (CF) treatments, which is currently looking to expand the label of its CF treatment, Orkambi. Orkambi, approved in Jul 2015, for the treatment of the underlying cause of CF in people (ages 12 and above) with two copies of the F508del mutation, is currently under FDA review for use in the 6-11 years age group. Approval for this age group would expand the patient population by about 2,400 in the U.S. A response from the agency is expected on Sep 30 and approval would be a positive catalyst for this Zacks Rank #3 stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
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.
Follow us on Twitter: https://twitter.com/zacksresearch
Join us on Facebook: https://www.facebook.com/home.php#/pages/Zacks-Investment-Research/57553657748?ref=ts
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
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.
SPECTRUM PHARMA (SPPI): Free Stock Analysis Report
AMGEN INC (AMGN): Free Stock Analysis Report
ABBVIE INC (ABBV): Free Stock Analysis Report
VERTEX PHARM (VRTX): Free Stock Analysis Report
Original post