Recently, Dynavax Technologies Corp. (DVAX) announced the completion of enrollment for the first of three cohorts of patients receiving DV-601 hepatitis B (HBV) therapy in an open-label, dose-escalating early-stage study. The second cohort has been opened for enrollment. All commercial rights to this product are with Dynavax. In the study conducted in Europe, up to 30 patients are to be administered with 6 injections of DV-601 over a period of three months. The study will evaluate the safety and tolerability of DV-601. The company expects to report top-line data from this study in the second half of 2010. HBV affects more than 350 million individuals globally. It is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. Currently the global market for HBV therapeutics is estimated at over $1 billion annually and available therapies have limited efficacy. Dynavax to Buy ...

In one of the most surprising news today, Dynavax Technologies Corporation (NASDAQ:DVAX) has announced that the first clinical data of their HEPLISAV has shown increase in the protection rate for chronic kidney disease patients. The data will be presented publicly in a poster session on Saturday, October 31, 2009 at the Annual Meeting of the Infectious Disease Society of America (IDSA) in Philadelphia, Pennsylvania.

Dynavax Technologies Corporation is a biopharmaceutical company that discovers and develops product candidates like Toll-like Receptor also known as TLR. HEPLISAV is a Phase 3 adult hepatitis B vaccine that provides increased and rapid protection to the patients with fewer doses compare to the current licensed vaccines available in the market. During the Phase 3 trial of HEPLISAV around 2500 individuals were vaccinated with

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Yesterday, Dynavax Technologies Corp. (DVAX) announced that it has resumed the late-stage registration trial of its hepatitis B (HBV) vaccine Heplisav in patients with chronic kidney disease. The trial will enroll 600 patients. Heplisav will be tested against GlaxoSmithKline plc’s (GSK) Engerix-B. The company intends to begin another late-stage registration trial in adults over 40 years of age in early 2010. Dynavax expects to complete both trials within the next 2 years. Management expects the vaccine to hit the market by the end of 2012 or early 2013.   As a reminder, Heplisav was on clinical hold in the U.S since March 17, 2008 following the occurrence of the severe adverse event (SAE) of Wegener's granulomatosis. The SAE was reported in the phase III study in healthy adults conducted outside the US. Wegener's granulomatosis is an uncommon disease which results in the inflammation of blood vessels. ...

Yesterday, Dynavax Technologies Corp. (DVAX) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its late-stage hepatitis B vaccine (HBV) Heplisav which is being developed for patients suffering from chronic kidney disease. As a reminder, Heplisav was on clinical hold in the U.S since Mar 17, 2008 following the report of the severe adverse event (SAE) of Wegener's granulomatosis. The SAE was reported in the phase III study in healthy adults conducted outside the U.S. Wegener's granulomatosis is an uncommon disease which results in the inflammation of blood vessels .The vaccine is being studied for both healthy adults and patients with end-stage renal disease. Consequent to the regulatory issues, the partnership with Merck & Co. Inc. (MRK) for Heplisav ended on December 19, 2008. All rights relating to the development and commercialization of Heplisav reverted to ...

I recently highlighted a small biotech firm, ISIS Pharmaceuticals, as a potential “value” growth play. ISIS took a tumble after earnings despite being just a penny off of estimates. Despite slightly lower than expected earnings, the Company showed a strong cash position, moderate cash burn, and a likelihood that it would be able to at least make it through full trials for its most promising drug. I know that for some even this doesn’t count as value. Afterall, the Company is not free cash positive and any value ascribed to the Company is derived from future expectations of its drug pipeline of which there are none currently in distribution.

For those looking for more proven business models but still looking to take advantage of the coming shift towards genetic pharmaceuticals as opposed to small molecule pharmaceuticals, a look at ISIS’s partners may clue you into some

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Dynavax Technologies Corp. (DVAX) is a biopharmaceutical company focused on drug development for the treatment and prevention of various infectious and inflammatory diseases.

The company was recently hit hard by a couple of major negative events: the clinical hold and the subsequent termination of the partnership with Merck (MRK) for Heplisav, a late stage candidate for Hepatitis B vaccine, and the discontinuation of the Tolamba program for allergy. Currently, Dynavax is in active discussions with regulatory agencies to resolve the FDA's clinical hold on Heplisav and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.

The deal with Glaxo is a big positive

In 4Q08, Dynavax and GlaxoSmithKline (GSK) signed a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases.

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HGSI: NDA for Albuferon Expected to be Filed This FallWaiting for 2 Phase III Results for BenlystaNDA filing for Albuferon is expected in the fall for Hepatitis C      Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences Inc. (HGSI) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.HGSI has an exclusive worldwide agreement with Novartis (NVS) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for chronic hepatitis C (HCV). Under this agreement, ...

Takeover Targets: 3 Steps To Finding Them & 3 Stocks For Any Portfolio

by Louis Basenese, Advisory Panelist Senior Analyst, The Oxford Club

I promise. Alexander Green and I are not in cahoots about the coming boom in corporate takeovers…

We both researched the possibility separately. Unprompted, I might add. And yet, armed with different evidence, we arrived at the same conclusion.

If you ask me, such a convergence of analysis in a narrow space of time shouldn’t be ignored. So today, let’s move on from why a takeover boom is imminent and focus exclusively on three takeover targets you can profit from…

Identifying The Market’s Next Takeover Targets

The task of identifying the market’s next takeover targets can be daunting. Literally thousands of potential targets exist, which is probably why most investors liken it to a crapshoot and in turn, shun such a strategy altogether.

But that’s a

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For Immediate Release

Chicago, IL - April 28, 2009 - 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: Dynavax Technologies Corp. (DVAX),Skyworks Solutions, Inc. (SWKS), Wilmington Trust Corp. (WL), Micromet Inc. (MITI) and Embraer (ERJ).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Monday's Analyst Blog:

Dynavax Surge Not Warranted

In early morning trading, Dynavax Technologies Corp. (NASDAQ: DVAX) shares shot up dramatically (36%). However, we don't see a clear reason for that.

The surge may be related to two pieces of news: phase III Heplisav data and the swine

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Dynavax: Surge on Heplisav Phase III or Swine Flu? In early morning trading, Dynavax Technologies Corp. (DVAX) shares shot up dramatically (36%). However, we don't see a clear reason for that.The surge may be related to two pieces of news: phase III Heplisav data and the swine flu breakout.The first piece of news is about its phase III candidate Heplivsav. This morning, the company announced the oral presentation of additional phase III clinical data for Heplisav hepatitis B vaccine in a session for late-breaking abstracts at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen, Denmark.In the presentation, Heplisav met its primary endpoint in this phase III trial and demonstrated the vaccine's potential to provide more rapid and increased protection against hepatitis B viral infection and with fewer doses than the licensed ...