Welcome!

News Feed Item

The Zacks Analyst Blog Highlights:GIlead, AbbVie, MannKind, Alkermes and Pharmacyclics

CHICAGO, April 17, 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), AbbVie (NYSE:ABBV-Free Report), MannKind (Nasdaq:MNKD-Free Report), Alkermes (Nasdaq:ALKS-Free Report)andPharmacyclics (Nasdaq:PCYC-Free Report).

Zacks Investment Research, Inc., www.zacks.com

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

Here are highlights from Wednesday's Analyst Blog:

Biotech Stock Roundup

The biotech selloff continued last week with NASDAQ Biotechnology declining 4.46% and the NYSE ARCA Biotech Index declining 5.01% at the end of the week. Even though some companies came up with positive developments, overall sentiment remained bearish.

FDA Action Date for Next GIlead (Nasdaq:GILD-Free Report)HCV Drug: Gilead could well have its next hepatitis C virus (HCV) drug approved later this year -- the company, which had filed for FDA approval of its once-daily fixed-dose HCV cocktail treatment -- ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) – said that the combination has been accept for review.

The FDA will decide on the approval status of this cocktail treatment by Oct 10. Approval would make this combination the first oral treatment for HCV patients with genotype 1 infection to be available in the U.S. The important thing is that patients would not need to take interferon or ribavirin (RBV), which are usually associated with greater side effects.

But competition is not far behind. Earlier this year, AbbVie (NYSE:ABBV-Free Report) had provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. AbbVie followed up with impressive data at the recently held International Liver Congress.

AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year.

Both treatments look effective with high cure rates. But Gilead's treatment is once daily while AbbVie's will require more frequent dosing. However, eventually pricing will play a role as well in share uptake.

Gilead should also watch out for Merck's combination treatment.

FDA Pushes out Action Date for MannKind's (Nasdaq:MNKD-Free Report) Afrezza: The FDA, which was supposed to deliver a response regarding Afrezza's approval status by Apr 15, has delayed its decision by three months. So MannKind will now have to wait until Jul 15 before a decision of Afrezza is available. MannKind shares, which had surged almost 74% on a positive FDA panel, dropped 8% on the delay.

The delay should not come as a huge surprise – the FDA has a lot of information to sift through before it can arrive at a decision. Although an FDA advisory panel voted in favor of approving the drug, there are some concerns regarding safety. So the FDA will need some time to decide on the label as well as post-marketing requirements.

Alkermes (Nasdaq:ALKS-Free Report)Gains on Impressive Data: Alkermes shares were up on impressive top-line data from a pivotal study on its experimental schizophrenia drug aripiprazole lauroxil. The candidate was also found to be safe and well-tolerated. With the once-monthly injection achieving the primary as well as secondary endpoints in the study, Alkermes is set to file for FDA approval in the third quarter.

The schizophrenia market is pretty crowded given the presence of several oral antipsychotic drugs. However, of late, the treatment landscape is changing with doctors recognizing the advantages of long-acting injectable antipsychotics. This may work in aripiprazole's favor given its once-monthly dosing option (which provides dosing flexibility and enhances current treatment options). But then, it does not have first-mover advantage as other once-monthly dosing options are already available.

Pharmacyclics (Nasdaq:PCYC-Free Report)Seeks Imbruvica Label Expansion: Pharmacyclics has filed a regulatory application in the U.S. for its cancer drug, Imbruvica, based on data from a head-to-head study (in previously treated chronic lymphocytic leukemia -- CLL -- patients) versus Glaxo's Arzerra.

An interim analysis from the study earlier this year showed a statistically significant improvement in progression-free survival as well as a statistically significant improvement in overall survival in the Imbruvica arm. Imbruvica, which has multi-billion dollar potential, is already approved for mantle cell lymphoma and CLL.

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.

Get the full Report on GILD - FREE

Get the full Report on ABBV - FREE

Get the full Report on MNKD - FREE

Get the full Report on ALKS - FREE

Get the full Report on PCYC - FREE

Follow us on Twitter: http://twitter.com/zacksresearch

Join us on Facebook: http://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

[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.

Logo - http://photos.prnewswire.com/prnh/20101027/ZIRLOGO

SOURCE Zacks Investment Research, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities. In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, posited that disruption is inevitable for comp...
DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City. ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per...
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
At the keynote this morning we spoke about the value proposition of Nutanix, of having a DevOps culture and a mindset, and the business outcomes of achieving agility and scale, which everybody here is trying to accomplish," noted Mark Lavi, DevOps Solution Architect at Nutanix, in this SYS-CON.tv interview at @DevOpsSummit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge...
HyperConvergence came to market with the objective of being simple, flexible and to help drive down operating expenses. It reduced the footprint by bundling the compute/storage/network into one box. This brought a new set of challenges as the HyperConverged vendors are very focused on their own proprietary building blocks. If you want to scale in a certain way, let's say you identified a need for more storage and want to add a device that is not sold by the HyperConverged vendor, forget about it...
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here)
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...