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

[wrangler]

Looks like shorts covering here also
Average Volume (3 month)3: 2,623,120
Average Volume (10 day)3: 4,333,010
Shares Outstanding5: 84.57M
Float: 83.48M
% Held by Insiders1: 9.62%
% Held by Institutions1: 34.20%
Shares Short (as of 09-Nov-07)3: 29.99M
Short Ratio (as of 09-Nov-07)3: 16
Short % of Float (as of 09-Nov-07)3: 36.00%
Shares Short (prior month)3: 29.58M

[la-onda]

DNDN: Short Interest UP 2.8% to 33.6M at the End of Aug 2008
Wednesday, September 10, 2008 16:17ET

According to new short interest data from NASDAQ, short interest for Dendreon Corporation (NasdaqNM: DNDN) INCREASED 2.8% to 33,599,660 shares as reported at month-end August, 2008.

Based on DNDN's 20-day average daily share volume of 1,135,895, it would require approximately 30 day(s) of buying to cover this short interest.

[setravis]

Spec play (Long Recommendation)
DNDN has been holding this level for some time now liking the action.
This stock could go back to $16 based on all news release..

52wk Range: 4.05 - 10.00
Volume: 805,731
Avg Vol (3m): 1,263,880

Technicals
Last Price Quote is:
-2.45%below 13-day MA
-6.04%below 50-day MA
RS Rating: 32 

Fundamentals
Key Data:
Market Cap (M): $431.39 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/04/2009
Last Analyst Rating: Sell

[setravis]

Dendreon Shares Soar Over Good News On Provenge...

The American Urological Association has added a "placeholder" for the highly anticipated data on Dendreon's prostate cancer treatment, Provenge, as a prostigious "late breaker" at the group's upcoming annual conference, CNBC has confirmed.

The information was posted on the AUA website today and confirmed by Dendreon's [DNDN  5.99    1.65  (+38.02%)   ] CFO Greg Shiffman.

Late-breaker status means clinical trial restults are important enough to warrant being highlighted in a larger, marquis venue at a scientific conference.

Provenge is the controversial theraputic vaccine for prostate cancer.

The data to be presented are from a late-stage clinical trial and, if positive, would provide a basis for potential FDA approval of Provenge. The result could be presented the end of this month at the AUA's annual meeting in chicago if they are ready in time.

Dendreon has previously communicated the data would be available in April. AUA is simply keeping a place in the program open for the Provenge results in the event they are ready.

DNDN shares closed at $5.99 a share, up more than 38 percent.

-----------------------------------------------------------------------------------------------------

52wk Range: 2.55 - 10.00
Volume: 22,413,741
Avg Vol (3m): 2,366,820

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
44.54%above 13-day MA
54.20%above 50-day MA
RS Rating: 84 

Fundamentals
Key Data:
Market Cap (M): $434.05 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Sell

[setravis]

Spec play (Long Recommendation)
DNDN has been holding this level for some time now liking the action.
This stock could go back to $16 based on all news release..

Finally...shares at 24+ in premarket..."what a difference a day makes"...congratulations to all that held on to your shares...retire and enjoy!!!

[setravis]

Buy signal...
Seems to be ready for additional run up prior to news later this month.
Current Action...
Represents positive momentum for DNDN, I forsee this stock moving forward with it's cancer treatment and finding a partner. This could easily cash in, within the 24 to 36 area.
Go DNDN, sustained immune responses that correlate with survival points and can be boosted that will Not affect the immune reaction...Need I say anymore. THE SHORTS WILL/HAS BEEN caught BIG TIME on this one; especially, with the information coming out on a Sunday, morning. 
Hold Long and make the SHORTS pay dearly for the shares at least $30.


52wk Range: 2.55 - 22.10
Volume: 17,717,575
Avg Vol (3m): 4,955,940

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
77.13%above 13-day MA
207.29%above 50-day MA
RS Rating: 99 

Fundamentals
Analyst Upgrade to Buy

Key Data:
Market Cap (M): $1,766.65 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Buy

[setravis]

Press Release Source: Dendreon Corporation
Dendreon Announces Data on PROVENGE Potency and Long-Term Immune Responses in Androgen-Dependent Prostate Cancer
Sunday April 19, 2009, 10:00 am EDT


Data presented at 100th Annual Meeting of the American Association for Cancer Research --

SEATTLE and DENVER, April 19 /PRNewswire-FirstCall/ -- Researchers from Dendreon Corporation (Nasdaq: DNDN - News) presented today data from its PROTECT (PROvenge Treatment and Early Cancer Treatment) or P-11 Phase 3 study suggesting that PROVENGE® (sipuleucel-T) induces long-term memory immune responses that are durable and can be maintained following boosting. The results of the study also indicate that CD54 upregulation on Antigen Presenting Cells (APCs), a measure of potency, is a correlate of immune activation.

P-11 is an ongoing Phase 3 clinical trial designed to evaluate the safety and biologic activity of PROVENGE in patients with non-metastatic androgen-dependent (hormone sensitive) prostate cancer who have had a prostate-specific antigen (PSA) recurrence following surgical removal of the prostate. Patients were randomized to PROVENGE or placebo following 3 months of hormone therapy. This study evaluated CD54 upregulation and peripheral immune responses in men enrolled in the trial.

PROVENGE or placebo was administered at weeks zero, two and four. A treatment booster infusion of PROVENGE or placebo was offered after confirmed PSA greater than or equal to 3.0ng/mL. Immune responses were measured pre-treatment, at weeks four and 13, and at four and 13 weeks following the booster infusion.

At the week zero dose of PROVENGE, the expression of CD54 on APCs was upregulated 5.8 fold. At the week two dose, it was 10.1 fold, significantly increased from week 0 (p < 0.001). The increase in CD54 upregulation persisted at week four (10.7 fold) and at the time of the booster infusion (12.0 fold). There was an increase in cellular immune response between pre-treatment and week four (p < 0.001), which persisted through 13 weeks after the booster infusion (p < 0.001). The PROVENGE booster infusions occurred from 0.2 to 5.5 years (median 1.1 years) after the week four dose.

Data is being presented in a session titled, "Cancer Vaccines: Human Studies" in a presentation titled, "Antigen presenting cell activation in sipuleucel-T and long-term immune responses in prostate cancer trial" today at 8:00 AM MDT at the 100th Annual Meeting of the Association for Cancer Research in Denver, Colorado.

"We are encouraged to see that CD54 upregulation in APCs is maintained after boosting in men with androgen-dependent prostate cancer," said David Urdal, chief scientific officer of Dendreon. "This pattern of CD54 upregulation suggests that the first dose 'primes' the immune system for subsequent 'memory' responses and is consistent with that observed in our studies of men with androgen-independent disease where the cumulative CD54 upregulation dose correlated with survival. We also are encouraged by these data which suggest that the immune response generated by PROVENGE is durable for a year or more after initial treatment and that it can be maintained following boosting."

Study Design

The study, known as PROTECT (PROvenge Treatment and Early Cancer Treatment) or P-11, is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and biologic activity of PROVENGE in men with non-metastatic androgen-dependent prostate cancer who have had a prostate-specific antigen (PSA) recurrence following surgical removal of the prostate. A total of 176 patients at 19 sites in the United States were randomized two to one to receive PROVENGE or placebo following a three-month course of hormonal therapy. Patients were then followed with serial PSA measurements to evaluate the impact of PROVENGE on PSA and PSADT (PSA doubling time). At the time of biochemical progression, defined as a PSA of 3 ng/mL or greater, men became eligible for one booster infusion of either PROVENGE or placebo in accordance with the treatment arm to which they were randomized. Patients continue to be followed for the clinical endpoints of time to distant failure, which typically would be the appearance of a positive bone scan, and for overall survival.

About PROVENGE

PROVENGE ® (sipuleucel-T), an investigational product in development for men with androgen-independent prostate cancer, may represent the first product in a new class of active cellular immunotherapies (ACIs). PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

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 is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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.


Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further 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.

[setravis]

Dendreon's Provenge: Moment of Truth
04/27/09 - 09:00 AM EDT


If Dendreon(DNDN Quote) is now king of all cancer vaccines, the company's coronation may come Tuesday inside a Chicago convention hall.

That's where a large crowd of urologists (and perhaps an equal number of investors) are gathering to witness the presentation of data from a pivotal clinical trial of Provenge, Dendreon's cancer therapeutic vaccine.
Dendreon shares are up markedly ever since the company announced April 14 that the phase III Provenge study was successful in extending the lives of men with advanced prostate cancer. Missing from Dendreon's triumphant announcement, however, were any details from the study, including the specifics about Provenge's survival benefit.


Which is why the annual meeting of the American Urological Association at Chicago's McCormick Place convention center is suddenly so important. The Provenge data, culled from the phase III study known as IMPACT, will be presented at 2:20 p.m. Central Daylight Time.

The continued rally in Dendreon's stock price depends on the actual Provenge data matching, or exceeding, expectations set by the company's April 14 announcement.

What exactly are those Provenge expectations? They're hard to pinpoint precisely, but Dendreon CEO Mitch Gold stated that the survival benefit seen in the IMPACT trial was "consistent" with results in the previous Provenge studies. That suggests a survival benefit favoring Provenge in the range of four to four-and-a-half months compared to patients in the control arm.

The IMPACT study was designed to succeed if Provenge could reduce the risk of death by 22%. Stated statistically, that equates to a "hazard ratio" of 0.78. Again, Dendreon hasn't provided any hard numbers yet, but the company did state that Provenge hit its pre-specified level of statistical significance, which implies at least a 22% reduction in the risk of death.

Dr. Howard Adler, a urologist and director of the Prostate Care Program at the State University of New York, Stony Brook, predicts a four-month survival benefit for Provenge but says that anything more than two to three months will be viewed by most doctors as positive and clinically meaningful for prostate cancer patients.

Taxotere, marketed by Sanofi-Aventis(SNY), is the only other prostate cancer drug used extensively to treat patients with advanced disease, with a known survival benefit of two to three months.
"If Taxotere could be approved [by the FDA] with a survival benefit of two to three months, then that should also be good enough for Provenge, especially since Provenge is going to be safer and more easily tolerated than Taxotere," said Adler.

While the Provenge data appear to be very positive, not everyone is a believer just yet.

Dr. Robert Reider, a professor of urology at the UCLA Jonsson Comprehensive Cancer Center, is a self-described Provenge skeptic in part because he's uncomfortable that Provenge appears to prolong patient survival without having any measurable effect on the tumor itself.

"In all the studies to date, Provenge has not stopped tumors from shrinking, nor has it had any positive effect on a patient's quality of life or PSA scores," said Reider. PSA is a protein marker found in blood used to detect prostate cancer.

"There has never been a drug approved that improved survival yet had no impact on the disease itself," Reider added, although he conceded that Provenge may well be the first if the drug posts a strong survival benefit Tuesday afternoon.

[setravis]

April 29, 2009, 6:56 PM ET.
Provenge Data Give Dendreon a Takeover Glow

After its stock fell off a cliff yesterday only to soar back later, Dendreon is looking no worse for wear today. In fact, it was looking all the better to some on Wall Street as a potential takeover target.

Analysts are focusing on study data for its new prostate cancer treatment Provenge rather than the latest stock gyrations. Reuters notes the seven analysts following the company had two "sell" ratings and five "hold" ratings on the stock a little more than two weeks ago; now now five have "buy" or "outperform" and two have "holds."

"If you look at a product like Provenge that could be on the market by mid next year, that's a product that could be instantly accretive to earnings," Joe Pantginis, an analyst for Merriman Curhan Ford & Co., told Reuters.

The often-volatile Dendreon stock jumped 94% to $22.94 today after reaching as high as $27. That followed its plunge yesterday just before the new study results were to be detailed as our earlier posts described here and here.

Market watchers were still trying to figure out what caused the sudden plunge, which Nasdaq says it is investigating. An order-entry error was believed to be one possibility.

Of course, Provenge still needs FDA approval to reach market, something the agency balked at doing before the new study was completed. But many biotechs with far dimmer prospects have been snapped up by pharma shops desperate to strengthen their pipelines of experimental drugs.


52wk Range: 2.55 - 27.40
Volume: 48,318,944
Avg Vol (3m): 7,002,590

Technicals
Record Price High
Close Above the 13-day E
MA
Most Actives
Percentage Gainer
Price Gainer

Last Price Quote is:
35.21%above 13-day E
MA
130.59%above 50-day E
MA
RS Rating: 99 

Fundamentals
Analyst Upgrade to Buy
Earnings Expected on May 7

Key Data:
Market Cap (M): $1,971.89 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Outperform

[setravis]

Dendreon Study Removes Uncertainty
On Wednesday April 29, 2009, 11:32 am EDT


Yesterday (April 28), Dendreon Corp. (NasdaqGM: DNDN - News) shares swung widely before the final data of IMPACT trial were reported. Share price of this tiny biotech company rose as high as $25 and then declined to as low as $7.5 per share, which prompted a brief probe and trade halt by the NASDAQ market oversight body.

We believe the wild ride reflected investors' nervousness about the data of the company's phase III IMPACT trial for Provenge.

At 2 pm ET yesterday, Dendreon reported detailed data at the American Urological Association (AUA) Annual Meeting held in Chicago. Key findings from the trial include:

Provenge extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months). Provenge improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%). The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by the study's design (p-value less than 0.043), and Provenge reduced the risk of death by 22.5% compared to placebo (HR=0.775).

Provenge exhibited a favorable safety profile consistent with prior trials.

We think the data are robust, which confirmed findings from previous clinical studies for Provenge for the treatment of prostate cancer.

Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year. Now the FDA has all the data it needs to approve Provenge. The agency will probably take 6 months to review the filing.

We believe the FDA will finally approve Provenge in mid-2010 based on the IMPACT results. We also expect the company will announce a partner for Provenge in Europe soon.

We think the approval of Provenge is not only an incremental advance to prostate cancer patents but also a big win for science. Once approved, Provenge will represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.

Provenge has blockbuster potential if it is approved for marketing. We estimate US sales will be $120 million in 2010, and $200 million in 2011, respectively. We further estimate the company will be profitable in 2010 with an EPS of $ 0.36. With sales potential over $1 billion, Provenge will provide both top-line and bottom-line growth for Dendreon in the coming years.

We reiterate our Buy rating on DNDN.

[setravis]

Dendreon Investors, Be Patient 
This company is on the up. It is a high beta stock and will not trade with the market. Look at the calls...there are around 50 thousand $30 may calls. I'm telling you this will be over $30 come expiration in 2 weeks since yesterday was the first Friday of the month.



52wk Range: 2.55 - 27.40
Volume: 7,376,011
Avg Vol (3m): 7,358,820

Technicals
Last Price Quote is:
20.90%above 13-day MA
102.94%above 50-day MA
RS Rating: 99 

Fundamentals
Earnings Expected on May 7

Key Data:
Market Cap (M): $2,161.42 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Outperform


Relax, people!

Dendreon isn't going to $30 overnight. All is well. The stock will probably work higher over time. Sensibly, hopefully, once the drama (insanity might be a more apt description) of this past week subsides.

Look at this way: For the past two years, Dendreon has been largely a trading vehicle, exquisitely sensitive to all types of rumors and innuendo. It takes time to transition from that short-term mindset to a stock that is more suitable for investment.

Dendreon is in the transition period now. This week brought concrete clinical evidence that Provenge extends the lives of men with prostate cancer. The data are good and consistent. As I said earlier this week, Wall Street spent Tuesday afternoon looking for red flags in the Provenge data, but came up with very little of consequence.

[setravis]

updated chart look...


52wk Range: 2.55 - 27.40
Volume: 7,467,961
Avg Vol (3m): 7,981,710


Technicals
Close Above the 13-day MA
Stochastic - Bullish

Last Price Quote is:
7.30%above 13-day MA
62.70%above 50-day MA
RS Rating: 99 

Fundamentals
Analyst Downgrade to Sell

Key Data:
Market Cap (M): $1,940.40 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/10/2009
Last Analyst Rating: Sell

[setravis]

Dendreon Investors, Be Patient 
This company is on the up. It is a high beta stock and will not trade with the market. Look at the calls...there are around 50 thousand $30 may calls. I'm telling you this will be over $30 come expiration in 2 weeks since yesterday was the first Friday of the month.



Relax, people!

Dendreon isn't going to $30 overnight. All is well. The stock will probably work higher over time. Sensibly, hopefully, once the drama (insanity might be a more apt description) of this past week subsides.

Look at this way: For the past two years, Dendreon has been largely a trading vehicle, exquisitely sensitive to all types of rumors and innuendo. It takes time to transition from that short-term mindset to a stock that is more suitable for investment.

Dendreon is in the transition period now. This week brought concrete clinical evidence that Provenge extends the lives of men with prostate cancer. The data are good and consistent. As I said earlier this week, Wall Street spent Tuesday afternoon looking for red flags in the Provenge data, but came up with very little of consequence.

52wk Range: 2.55 - 27.40
Volume: 5,130,689
Avg Vol (3m): 9,022,650

Technicals
Close Above the 13-day MA

Last Price Quote is:
2.68%above 13-day MA
19.82%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $2,419.45 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/10/2009
Last Analyst Rating: Hold

[setravis]

Dendreon Raising Money

Seattle-based biotechnology company Dendreon (NasdaqGM: 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 AdenoCarcinoma Treatment) study of Provenge in men with advanced prostate cancer. Following the positive results, the company is once again gearing up to market Provenge once the FDA approval comes through.

Provenge has blockbuster potential; we estimate U.S. sales to be $120 million in 2010 and $200 million in 2011. If the drug is approved, we believe the company will be profitable in 2010. Dendreon will market Provenge in the U.S. on its own and we expect it to announce a partner for the drug in rest of the world soon.

Dendreon will market Provenge in the U.S. on its own. However, on a global basis, we anticipate a partner soon. Once sales start to flow, Dendreon can focus back on the development of its pipeline candidates once more.

Following the positive results announced in late April, Dendreon's shares have been on the upswing and is trading above the $20 mark. The stock closed on July 2 at $23.48. We believe that the current share price represents an attractive entry point for long-term investors.

[setravis]

Pulled back into buy range...chart looks good...
following the 13-day MA up, really seems to have finally found a base. It should stay pretty stable. Then when 50-day MA gets closer look for a pop to the upside.
Target $33-38, stop $23. Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of therapeutics to enhance cancer treatment options for patients. It's only major candidate close to approval is Provenge for prostate cancer. If approved, it can be a huge blockbuster for the company.


52wk Range: 2.55 - 27.40
Volume: 1,993,934
Avg Vol (3m): 3,979,230

Technicals
Last Price Quote is:
-1.10%below 13-day MA
3.54%above 50-day MA
RS Rating: 48 

Fundamentals
Earnings Expected on Aug 11

Key Data:
Market Cap (M): $2,441.64 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/11/2009
Last Analyst Rating: Hold