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Dendreon to Seek FDA Approval – Analyst Blog

Zacks Market Commentaries (October 9th, 2009) Writes:
Recently, Dendreon Corp. (DNDN) announced that it intends to file an amendment to its existing Biologic License Application (BLA) for its prostate cancer vaccine Provenge in Nov. 2009. We believe that the US Food and Drug Administration (FDA) will approve Provenge in the first half of 2010 based on the positive phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results announced in Apr. 2009.   If approved, Dendreon will become the first company to receive approval for an anti-cancer immunotherapy based vaccine. In development studies, Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S.   Prostate cancer ...

Dendreon Awaits Provenge Approval – Analyst Blog

Zacks Market Commentaries (September 28th, 2009) Writes:
Dendreon Corporation (DNDN) is likely to become the first company to receive approval from the US Food and Drug  Administration (FDA) for an anti-cancer, immunotherapy based vaccine, as it released phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results for its key product candidate, Provenge, in April 2009. Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of 2009. We believe that the FDA will approve Provenge in the first half of 2010 based on the positive late-stage study results. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S. We believe Provenge could have blockbuster potential if it is approved by the regulators. Prostate cancer is the most ...

Dendreon Raising Money – Analyst Blog

Zacks Market Commentaries (July 7th, 2009) Writes:

Seattle-based biotechnology company Dendreon (DNDN) recently raised more than $200 million through the issuance of 10.7 million shares of its common stock in a public offering. In addition, it granted offering manager Deutsche Bank Securities an over-allotment of 1.3 million shares to support the manufacture and marketing of Provenge.

Provenge, a therapeutic vaccine candidate being developed by Dendreon for the treatment of prostate cancer is likely to receive FDA approval in the first half of 2010. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells.

We remind investors that the company met with disappointment in 2007 when the FDA asked for further data before approving it. The disappointing news had caused the company to retrench 15% of its workforce and sent its shares on a downward journey.

However, in April 2009, Dendreon reported positive results from its IMPACT (IMmunotherapy for Prostrate

...

Zacks Industry Outlook Highlights: Myriad Genetics, Onyx Pharmaceuticals Inc., AMAG Pharmaceuticals Inc., Dendreon and 3SBio Inc. – Press Releases

Zacks Market Commentaries (June 1st, 2009) Writes:
For Immediate Release

Chicago, IL - June 1, 2009 - Zacks.com releases the latest Industry Outlook. Today's interview is with senior analyst Grant Zeng, who talks about the Biotech Industry, including Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX), AMAG Pharmaceuticals Inc. (AMAG), Dendreon (DNDN) and 3SBio Inc. (SSRX).

A synopsis of today's Industry Outlook is presented below. The full article can be read at http://at.zacks.com/?id=2678.

Our best picks at this point include Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX) and AMAG Pharmaceuticals Inc. (AMAG), Dendreon (DNDN) and 3SBio Inc. (SSRX). We have different reasons for a BUY rating for each of the four companies, but all of these companies have one thing in common -- strong balance sheets, which eliminates immediate financing needs.

Both MYGN

...

Biotech Industry – Zacks Analyst Interviews

Zacks Market Commentaries (June 1st, 2009) Writes:
OVERVIEW

The Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).

At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.

This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined as much as over 40% (34%, 41%

...

Biotech Industry – Industry Outlook

Zacks Market Commentaries (May 29th, 2009) Writes:
OVERVIEWThe Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined ...

Dendreon Gets Positive IMPACT – Analyst Blog

Zacks Market Commentaries (April 14th, 2009) Writes:
Positive IMPACT trial results will likely lead to Provenge approval by the FDA in 1H10This morning, Dendreon Corporation (DNDN) announced results of the long-awaited pivotal phase III IMPACT study of Provenge in men with advanced prostate cancer. In the news release and the conference call, management disclosed that the phase III study met its primary endpoint of improving overall survival compared to a placebo. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of Provenge appeared to be consistent with prior trials.As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine. Previous two phase III studies ...

Zacks Analyst Blog Highlights: Valero Energy, PartnerRe Ltd., Dendreon Corp., Dell Inc. and Hot Topic Inc. – Press Releases

Zacks Market Commentaries (April 7th, 2009) Writes:
For Immediate Release

Chicago, IL - April 7, 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: Valero Energy (VLO), PartnerRe Ltd. (PRE), Dendreon Corp. (DNDN), Dell Inc. (DELL) and Hot Topic Inc. (HOTT).

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:

VLO Entering the Ethanol Business

Valero Energy (VLO), the largest North American refiner, has entered the ethanol business in a big way by acquiring the eight (8) ethanol plants of the bankrupt VeraSun Energy in a bankruptcy court auction. (VeraSun Energy went bankrupt

...

Cautious on Dendreon’s Rally – Analyst Blog

Zacks Market Commentaries (April 6th, 2009) Writes:
Shares of Dendreon Corp. (DNDN) jumped 38 percent last Friday and another 13% in early morning trading today. However, we don't see any clear rationale for the rally at this point of time. We believe investors are looking ahead to long-awaited data on the company's experimental Provenge vaccine to treat advanced prostate cancer, but we are cautious about the final results anticipated by the end of April. As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine.Previous two phase III studies generated mixed results. Study D9901 showed that Provenge approached, but did not meet its primary end point of showing a significant delay in time to disease progression (p=0.052, HR=1.4). However, Provenge showed a statistically significant median survival benefit (secondary endpoint) in ...

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