Companies featured in this edition of the newsletter: ACTC, CHIP, CVM, DKAM, ENZ, IWEB, MBCI, MFGD, PHC

Markets rebounded last week, on the strength of upbeat productivity and manufacturing reports that led to solid gains in all of the major indices. Despite news that the unemployment rate had hit its highest levels in 25 years, the Dow managed to end the week up 310 points, gaining 3.2% on the week to close at 10,023, up 14.2% on the year. The Nasdaq posted a gain of 3.3%, closing at 2112 and extending its yearly gains to 34%, while the S&P 500 and Russell 2000 advanced 3.2% and 3.1% respectively on the week to bring their YTD performance to 18.4% and 16.2%.

Several better than expected economic reports provided buying incentive throughout much of the week, as investors managed to shake off the previous week’s negative bias to send indices into positive territory

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Competition in the biotech sector is always cut-throat and that is what makes this sector more dynamic than any other as the faith of the company lies directly in the hands of the researchers that come out with life saving drugs that can sweep the market by storm. Currently the hepatitis C drug called telaprevir from Vertex Pharmaceuticals is going through the Phase III clinical trials and is expected to be the first new drug in years to be approved for the treatment of chronic liver disease. However, the question is how long can telaprevir maintain its importance in the market? And which drug will come up as a major competitor for telaprevir in the next few years?

Boerhinger Ingelheim’s BI-201335, better known as drug 335 is one major competitor

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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 ...

Raptor Pharmaceuticals Corp. is a development-stage biotechnology company with their corporate headquarters in Novato, California. They engage in the acquisition, development, and commercialization of pharmaceutical products in the United States. As an OTCBB-traded enterprise, they dedicate their efforts to speeding the delivery of new treatment options to patients. They do this by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise.

The company focuses on underserved patient populations. Their DR Cysteamine is an investigational, delayed-release (DR) oral formulation of cysteamine bitartrate. This is for the potential treatment of nephropathic cystinosis (cystinosis), which is a rare lysosomal storage disease. Raptor’s DR Cysteamine formulation may require less frequent dosing and reduce gastrointestinal side effects. They are also developing DR Cysteamine for the potential treatment of Non-alcoholic Steatohepatitis (NASH), Huntington’s Disease, and Batten Disease. Raptor is also in clinical development of Convivia™. They are developing

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Salix Pharmaceuticals Ltd. (SLXP) yesterday announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to its new drug application (NDA) for  rifaximin 550 mg. Salix is seeking approval for the use of rifaximin for the maintenance of remission of hepatic encephalopathy (HE).

Priority review status is granted to drugs, which offer major advances in treatment or provide a treatment where no adequate therapy is available. Rifaximin has also been granted Orphan Drug designation in the U.S. for the HE indication.

While the FDA has issued an action date of Dec 24, we believe the FDA decision will be pushed back by a few months as the candidate is expected to come up for review by an FDA advisory committee in late February 2010.

According to the company, the HE market in the U.S. represents commercial opportunity in the range of $600 million. Hepatic encephalopathy occurs frequently in patients

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Theravance [THRX: 14.54, 0.00 (0.00%)]: On 4/24/09, the FDA accepted as complete for review Theravance’s response to the February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is

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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 ...

There are signs of both a potential market recovery (the beginning of a larger bull rally), and signs that this recent 20%+ run-up was nothing more than a bear market rally.

The good news is that there will be plenty of opportunities going forward, regardless of which of the above scenarios plays out.

Bull Market Rally Scenario

The move that we have recently seen, i.e., 24.82% in the Dow Jones Industrial Average ($DJI), 26.82% in the S&P 500 (SPX), and 28.26% in the Nasdaq (COMP), from the lows made in early March to the highs made just 4 weeks later, suggests a larger move could be in store.

For one, it's generally believed that a 20% rise

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Raptor Pharmaceuticals Corp. is a development-stage biotechnology company with their corporate headquarters in Novato, California. They engage in the acquisition, development, and commercialization of pharmaceutical products in the United States. As an OTCBB-traded enterprise, they dedicate their efforts to speeding the delivery of new treatment options to patients. They do this by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise.

The Company focuses on underserved patient populations. Their DR Cysteamine is an investigational, delayed-release (DR) oral formulation of cysteamine bitartrate. This is for the potential treatment of nephropathic cystinosis (cystinosis), which is a rare lysosomal storage disease. Raptor’s DR Cysteamine formulation may require less frequent dosing and reduce gastrointestinal side effects.

The company is also developing DR Cysteamine for the potential treatment of Non-alcoholic Steatohepatitis (NASH), Huntington’s Disease, and Batten Disease. Additionally, Raptor is in clinical development of Convivia™ for the

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