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
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Regulatory requirements exist to promote the controlled sharing of information, while protecting the privacy and/or security of the information. Regulations for each type of information have their own set of rules, policies, and guidelines. Cloud Service Providers (CSP) are faced with increasing demand for services at decreasing prices. Demonstrating and maintaining compliance with regulations is a nontrivial task and doing so against numerous sets of regulatory requirements can be daunting task...