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DNDN - Sector: Healthcare---Industry: Biotechnology & Drugs

Started by saffeysite1, May 14, 2005, 07:25:41 PM

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setravis

3 Reasons to Buy Dendreon Today

Historically, tumultuous times offer some of the best opportunities to buy stocks, and the market's recent mess surely qualifies. And while the price of biotech Dendreon (Nasdaq: DNDN) is already up about 450% this year, some investors think the stock still has room to run


1. Provenge
Many investors are betting that cancer drug Provenge will get approval from the Food and Drug Administration by the expected decision date in May, and expect it to reach blockbuster status once production ramps up. The drug appears to be more effective than sanofi-aventis' (NYSE: SNY) Taxotere and could fetch a high price, like other cancer drugs from Genentech, Eli Lilly (NYSE: LLY), and Bristol-Myers Squibb (NYSE: BMY), reaching up to $2.5 billion in annual sales, according to some estimates.

2. Building a cash machine
Dendreon is charging forward with moves to become a pharmaceutical company with a marketable drug -- it's raising cash, building new facilities, and beefing up its marketing. While companies like Onyx Pharmaceuticals (Nasdaq: ONXX), Amylin Pharmaceuticals (Nasdaq: AMLN), and Elan (NYSE: ELN) have marketing partners for their major drugs, some investors like the additional value that comes with Dendreon because it doesn't have one, at least for the U.S.

3. More than a one-trick pony
It's also important to point out that Dendreon is not hanging its future on just one treatment. In addition to Provenge, members like the additional technologies and drugs that Dendreon is developing to fight other types of cancer. It has other active cellular immunotherapies in early stage clinical trials that some see as having the potential to add significant value.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

3 Reasons to Sell Dendreon Today

The turmoil in the markets makes it too easy to justify selling any stock these days. Yet, while panic never helps investors, it's still a good idea to play devil's advocate with investments.
Though its pipeline shows significant promise.


1. Waiting for profits
While Provenge could bring billions of dollars in annual sales if it gets approved, Dendreon expects to incur more losses for the next several years while it ramps up manufacturing capacity and marketing efforts. The company posted a wider loss in the third quarter, and some people prefer investing in a stock that has billions in free cash flow, like Pfizer (NYSE: PFE), Novartis (NYSE: NVS), or GlaxoSmithKline (NYSE: GSK), to complement dozens of potential drugs in development.       

2. Speculative play
Shares of Dendreon have earned and have already generated huge gains this year, similar to the spike in Vanda Pharmaceuticals (Nasdaq: VNDA). While some members continue to be bullish about the potential of Dendreon's pipeline, others aren't willing to shoulder the additional risk priced into shares and shy away from the possible volatility involved with approval for Provenge and the uncertainty of its other drug candidates.

3. Uncertainties remain
Another high-cost drug, Eli Lilly's (NYSE: LLY) and Bristol-Myers Squibb's (NYSE: BMY) Erbitux, has come under scrutiny recently as lawmakers and health officials try to rein in medical costs. Some members show concern about the price Dendreon might be able to command for Provenge and the possible changes in health-care reform that might affect its pricing.

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

DNDN = Goldmine!
DNDN will get gobbled up sometime in 2010.
Even with the recent secondary stock offering,
I can see a buyout price between $60 - $80 a share...

52wk Range: 2.55 - 30.42
Volume: 1,654,884
Avg Vol (3m): 2,756,940

Technicals
Last Price Quote is:
-1.72%below 13-day MA
-4.11%below 50-day MA
RS Rating: 28 

Fundamentals
Key Data:
Market Cap (M): $2,992.35 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/11/2010
Last Analyst Rating: Buy

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

la-onda

 ;) I am fully agreeing with your statement setravis, a big winner in 2010  >:D

la-onda

just chart update, a winner stock in 2010  >:D

la-onda

chart update

setravis

Quote from: la-onda on December 31, 2009, 04:53:13 AM
just chart update, a winner stock in 2010  >:D

la-onda ,Today a nice move...  ;)
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

la-onda

#562
 >:D >:D

DNDN: Roth Capital Starts @ Buy
Thursday , January 07, 2010 08:31ET
Issuer: Dendreon Corporation (NasdaqNM: DNDN)
Analyst Firm:  Roth Capital Partners Inc.
Ratings Action: INITIATE
Current Rating: Buy
Target:50$

&

Sanofi Buys Dendreon

Both companies are working on drugs for prostate cancer. Everything with Dendreon (DNDN) hinges on its cancer drug, Provenge. The drug was approved in 2007 and then revoked pending new data from a continuing study. That data was released earlier this year and met all target points. On that alone, the drug stands a great chance, never mind the fact that the results exceeded expectations. Management and the FDA are working closely together to work through the issues. Sanofi (SNY) already has a prostate cancer drug, Taxotere, with $2 billion-plus in sales. Taxotere has enormous side effects, however, compelling many men to prefer cancer than use the drug. Provenge solves many of the issues and Sanofi would probably love to scoop it up before Dendreon becomes a $50 stock post-approval.

James Altucher is a managing partner of Formula Capital, an alternative asset management firm, and an author on investment strategies. Unlike Dow Jones reporters, he may have positions in the stocks he writes about.

setravis

#563
Friday, April 30, 2010, 10:19am
In wake of FDA OK, Dendreon shares keep rising....... ;) :D ;D


One day after the U.S. Food and Drug Administration approved Dendreon Corp.'s Provenge prostate cancer drug, shares in the biotech keep rising.

On Thursday, shares in Seattle-based Dendreon rose more than 26 percent in early trading before falling back to close at $54.06, up nearly 8 percent, or up $3.88.

Analysts were cautious on the potential short-term volatility of Dendreon's shares (NASDAQ: DNDN).

Paul Latta, analyst at McAdams Wright Ragen brokerage, of Seattle, has rated the stock as "hold."

"We expect the stock will be somewhat volatile near term reflecting the entry of event-oriented investors ... and their follow-on potential exit," he said in a note to investors.

He notes that Provenge will be priced at $31,000 per patient infusion, with each patient receiving about three infusions.

"We are not making any changes to our sales or profitability projections. Dendreon plans to treat 2,000 patients in the first 12 months. The first patient is expected to begin treatment next week," Latta noted.


52wk Range: 19.15 - 57.67
Volume: 46,135,379
Avg Vol (3m): 4,789,310

Technicals
Record Price High
Most Actives
Percentage Gainer
Price Gainer

Last Price Quote is:
26.22%above 13-day MA
43.01%above 50-day MA
RS Rating: 96 

Fundamentals
Earnings Expected on May 3

Key Data:
Market Cap (M): $5,379.05 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/03/2010
Last Analyst Rating: Hold
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

SEATTLE, Sept 01, 2010 /PRNewswire via COMTEX/ -- Dendreon Corporation (DNDN, Trade ) today announced that management will present at the following investor conferences in September.

The following presentations will be webcast:



    Rodman & Renshaw 12th Annual Health Care Conference, New York, NY
    September 13, 2010
    9:35 a.m. ET

    Morgan Stanley 2010 Global Health Care Conference, New York, NY
    September 13, 2010
    2:10 p.m. ET

    Baird's 2010 Health Care Conference, New York, NY
    September 15, 2010
    1:45 p.m. ET

    Bank of America Merrill Lynch 2010 Global Health Care Conference,
     London, UK
    September 16, 2010
    6:20 a.m. ET





The presentations will be audio webcast live and available for replay from Dendreon's website, www.dendreon.com .

Dendreon Corporation is a biotechnology company targeting cancer and transforming lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first autologous cellular immunotherapy product, PROVENGE(R) (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Dendreon also is developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com

SOURCE Dendreon Corporation



"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

From looking at the chart,
appears to have formed a Head and Shoulders bottom reversal chart pattern...


Technicals
Close Above the 50-day MA
Close Above the 13-day MA
Most Actives
Percentage Gainer

Last Price Quote is:
10.29%above 13-day MA
11.42%above 50-day MA
RS Rating: 35 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

#566
8 Promising Biotech Buyout Targets if Their Products Can Deliver...

The following are a few biotechs with promising products in their pipelines that have made the big boys sit up and take notice. Without further ado, the 8 promising biotechs priced for a buyout if their products can deliver:

Dendreon Corporation (DNDN): Four billionaires recently purchased shares in this biotech firm focused on the development and commercialization of novel cancer therapies. The likely reason – the Centers for Medicare & Medicaid Services announced last Wednesday that it would support reimbursement for Provenge, the first "cancer vaccine." Provenge, an expensive prostate cancer therapy, prolongs patients' lives by an average of fourth months, and was deemed to be superior enough to existing alternatives that Medicare decided to pay $93,000 for each course of the therapy. The drug already looked like a potential blockbuster, but the recent news only increases its potential market and likelihood of becoming a moneymaking machine. The drug faces one last regulatory hurdle, but is expected to pass it this summer. Expect larger pharmaceutical companies to come sniffing around once it does. Shares currently trade at $41.78.

Technicals
Last Price Quote is:
7.97%above 13-day EMA
15.95%above 50-day EMA
RS Rating: 83  
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Dendreon up on study results...
Above the 50-day MA. MACD bottoming.

Day's Range: 41.90 - 42.50
52wk Range: 25.78 - 44.85
Volume: 3,227,508
Avg Vol (3m): 3,419,350
Market Cap: 6.18B

Technicals
Last Price Quote is:
6.99%above 13-day EMA
9.99%above 50-day EMA
RS Rating: 92 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

FDA Approves Dendreon's Los Angeles Cancer Immunotherapy Manufacturing Facility
-FDA Approval of 36 Workstations Further Supports National Availability of First-in-Class Prostate Cancer Immunotherapy PROVENGE-

Press Release Source: Dendreon Corporation On Wednesday June 29, 2011, 8:04 pm EDT
SEATTLE, June 29, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq:DNDN) today announced that the U.S. Food and Drug Administration (FDA) approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE® (sipuleucel-T) across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. 

The Los Angeles facility includes 36 workstations, and Dendreon will bring these new workstations online in a staged approach. With this FDA approval and the fully approved New Jersey facility, Dendreon now has total of 84 workstations available to manufacture PROVENGE. Dendreon expects to continue to provide additional capacity through the anticipated licensure mid-year of one other manufacturing facility in the United States.  In April, Dendreon filed a post-approval supplement for its third facility in Atlanta, for which there is an FDA action date of August 28, 2011.

PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class of drugs known as autologous cellular immunotherapies.

"As the foundation of care, PROVENGE is an important treatment option for men with metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The FDA approval of the Los Angeles facility will enhance our ability to provide PROVENGE to the many patients across the country who may benefit from it." 

In anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 active infusing sites by the end of the second quarter and approximately 500 by the end of 2011.

PROVENGE was approved based on three Phase 3 studies, including the pivotal, 512-patient Phase 3 IMPACT study, which showed that PROVENGE demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC). That trial showed PROVENGE extended median survival by 4.1 months compared to control.  Overall, PROVENGE reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Phase 3 Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.

PROVENGE Indication and Safety

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full prescribing information or call 1-877-336-3736.

About Prostate Cancer

According to the American Cancer Society, prostate cancer is the most common non-skin cancer in men in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 240,890 new cases and approximately 33,720 men expected to die from the disease in 2011.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response.  Dendreon's first autologous cellular immunotherapy product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

www.dendreon.com

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including commercialization of PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Medicare to Cover DNDN's Provenge

Friday July 1, 2011, 11:15 am EDT

Dendreon Corporation (NasdaqGS: DNDN) has of late been announcing significant milestones, related to its potential blockbuster cancer vaccine Provenge. Most recently, the company announced that the Centers for Medicare and Medicaid Services (CMS) has agreed to fully reimburse Provenge, an expensive vaccine. CMS is a federal agency that administers the Medicare and Medicaid programs, which provide health care coverage to millions of people in the US.

The agency has issued a final National Coverage Decision (NCD) for Provenge which will require Medicare contractors to cover the use of Provenge for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer which is consistent with its label. The agency has also issued specific guidelines to local Medicare Administrative Contractors (MACs) to pay for on-label use of Provenge. Provenge is currently reimbursed by all 15 local MACs. The agency did not propose to cover off-label use of the vaccine at the national level due to insufficient evidence.

The decision from the CMS does not come as a surprise for us as earlier intimation from the agency had supported Provenge coverage. The agency believed there was enough evidence to justify the use of Provenge for the treatment of advanced prostate cancer. Apart from that, last year, the CMS Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) supported reimbursement for on-label use of Provenge vaccine.

We are encouraged by CMS' decision to reimburse Provenge for on-label usage as it will allow doctors to be more comfortable with prescribing the drug. Moreover, reimbursement of the vaccine by Medicare is crucial for the commercial success of Provenge as it is primarily meant for men older than 60 who are dependent on Medicare for their treatment.

Provenge now also has the Q-code, which becomes effective from July 1. The Q-code is a product specific code that enables electronic submission of claims, which in turn can expedite payment, thereby facilitating the reimbursement process further.

Dendreon also intends to provide grants to independent foundations that provide financial assistance to qualifying prostate cancer patients. Dendreon will also establish a patient assistance program for uninsured patients.

The positive CMS decision comes on the heels of announcement of clearance from the US Food and Drug Administration (FDA) to expand manufacturing facility for manufacturing Provenge in the US. The company's Los Angeles facility can now be operational with 36 workstations. Earlier, in March 2011, Dendreon's New Jersey facility received FDA clearance. The facility has 48 workstations, some of which are already operational. The LA and NJ facilities, geared for manufacturing Provenge, now total 84. We believe the expanding manufacturing capacity will significantly increase the availability of Provenge which will help Dendreon to meet pent up demand for the vaccine. The company is also building additional capacity in Atlanta for which the FDA is expected to give its decision in August 2011.

All the above efforts are intended to help in making Provenge easily and broadly accessible to victims of prostate cancer. Prostate cancer is the most common non-skin cancer in men in the U.S. The disease affects more than 2 million men in the US. Efforts such as these would also increase demand for the vaccine.

Our Recommendation

We currently have a Neutral recommendation on Dendreon. The stock carries a Zacks #3 Rank (short-term "Hold" recommendation). We believe that the launch of Provenge has been impressive. Successful commercialization of Provenge is crucial for the financial performance of Dendreon as it can drive the company to profitability. We are encouraged by the company's efforts to expand capacity and CMS' decision to reimburse Provenge for on-label usage, which could subsequently spur sales at Dendreon. However, in the long run, we remain concerned about the company's dependence on Provenge and the lack of a robust pipeline. We believe Dendreon has little to fall back on if Provenge fails to keep its promise. We also remain cautious of the continuous up tick in operating expenses.

Moreover, there are products currently under development for treatment of prostate cancer. Johnson and Johnson's (NYSE: JNJ - News) Zytiga (abiraterone acetate) received FDA approval in April 2011 and Medivation's (NasdaqGM: MDVN - News) MDV3100 is in late stage trials. If these products prove to be successful, the prostate cancer market will become more crowded and competitive.


DENDREON CP (DNDN): Read the Full Research Report

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JOHNSON & JOHNSON (JNJ): Read the Full Research Report

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"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis