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

[la-onda]

fyi:
Dendreon (NASDAQ:DNDN): Expect to see additional buy interest today
- Banc of America has some positive comments on Dendreon (NASDAQ:DNDN) saying they anticipate an approval decision on Provenge by May 15th, under the condition of completing the Ph III IMPACT trial, and expect potential stock price appreciation in the near term. This view is based on firm's recent interviews with an ex-FDA general counsel, a regulatory executive in a major pharmaceutical company and CBER panel members.
Despite questionable statistical data, the decision remains highly political and given the safety profile, CBER appears motivated to approve additional products to stimulate R&D activities in cancer immunotherapy. BAC notes that Jesse Goodman, Director of CBER, appears to have influenced Celia Witten to 'lower the bar' by changing the efficacy question during the initial advisory panel voting and believe it is a good indicator of CBER's intentions.

Firm understands that DNDN is well prepared for a potential launch and believe Provenge can be out on the market by late 2007. If approved, they see potential upside to their TP to $29 and if an approvable letter is received potential downside to $6. Maintains Neutral as they remain cautious about the outcome of the IMPACT trial.

Notablecalls: DNDN was in play yesterday and I suspect this note by BAC's William Ho will create some additional buy interest in the name. Mr. Ho assigns a 2:1 (66%) probability to the approval. I suspect DNDN can move past the $18 level today.

[la-onda]

.......... 

My intuition, looking at the recent action, makes me think that 14.50-15 should be support.  And I think we could well see a bounce off this level as shorts from the $20 range start covering their positions.  I don't have any position in DNDN anymore (too much bloodshed made me re-think things a bit and I wanted to see where the dust settles), but considering the potential (and I still think we will se a provenge approval), I'll be looking to develop a position once again. 

Scotsman, DNDN is now inside your support area!
Will you invest again (shares/options) ?
If yes, before options expiration?
DNDN is definetly on my radar!

cheers from Singapore
Oliver

[ScottishTrader]

I already have, unfortunately in the low $17 area, but am looking to pick up some calls if we see the price stabilise here.  I still like the August calls more, as May calls could be a bit tight.

Interestingly, looking at the 1 month chart for the May 15 calls and puts, there was some very heavy volume of selling May 15 calls and buying 15 puts yesterday.  This also showed up on the 17.50 strikes.  Not totally sure what this may suggest, but someone is hedging heaily on provenge failing by the looks of it.

[la-onda]

just fyi; May 15th is coming soon

DNDN: Next Generation Ups to Buy from Hold; Sets Tgt @ $25
Thursday , May 03, 2007 09:41ET
Issuer: Dendreon Corporation (NasdaqNM: DNDN)
Analyst Firm:  Next Generation Equity Research
Ratings Action: UPGRADE
Current Rating: Buy (from Hold)
Target Price: $25.00

&
DNDN: AG Edwards Starts @ Hold; Analyst Notes
Thursday , May 03, 2007 10:11ET
Issuer: Dendreon Corporation (NasdaqNM: DNDN)
Analyst Firm:  A.G. Edwards Inc.
Ratings Action: INITIATE
Current Rating: Hold
Analyst Comments: The firm foresees significant risks surrounding the upcoming May 15th PDUFA action date for lead cancer vaccine Provenge. Provenge was the subject of a recent FDA panel meeting where committee members voted unanimously that Provenge was safe and 13 to 4 that there was substantial evidence of efficacy. Beyond a positive panel vote, there may be political forces within Center for Biologics Evaluation and Research (CBER) that increase the odds of Provenge being approved. However, given that Provenge failed to achieve any primary or secondary endpoints in either Phase III trial and that the primary statistical analysis for comparing overall survival was not pre-specified, the firm believes additional confirmatory data may be required by the agency.

[la-onda]

Dendreon Receives Complete Response Letter From FDA for Provenge(R) Biologics License Application
Wednesday May 9, 5:30 am ET

SEATTLE, May 9 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for PROVENGE (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.


The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner.

"Given our strong belief in the survival benefit and safety profile of PROVENGE, coupled with the positive outcome of the Advisory Committee meeting, we are disappointed that this decision will cause a delay in the availability of PROVENGE for patients who suffer from advanced prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring PROVENGE to patients with advanced prostate cancer who currently have few appealing treatment options."

On March 29, 2007, the FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee was asked if the submitted data established that PROVENGE is reasonably safe and whether there is substantial evidence that the product is efficacious. The Advisory Committee voted 17 to 0 in favor of the safety of PROVENGE and 13 to 4 in favor of the efficacy of PROVENGE.

PROVENGE Biologics License Application

Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

[ScottishTrader]

Oh dear.... It ain't gonna be pretty....

I'm holding a couple of August calls right now, which I may hold on to (depending on what price the stock opens at), but I think this will push DNDN back below $10 for the forseeable future.  Obviusly there were no time frames for resolution set forth in this PR, but one can expect that it will be a year to 18 months minimum before these issues are resolved, depending on whether they want full results from the IMPACT trial or not

[raspi]

I am glad to see that FDA wants to see more info on survival benefit. I was shocked that they would approve something that has no effect at all. Absence of adverse affects is meaningless even placebo has no adverse affects.
I have been trying to short DNDN for the past month but Interactive Brokers does not have DNDN available for short sale 

[akclide]

I think it is an over reaction.I just bought some June calls.I am hoping the over reaction to be in the tone of 2-3 dollars .Between today and tomorrow would like to see stock down 7-8 dollars and not 10+.

[setravis]

SEATTLE, May 10, 2007 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (DNDN, Trade) today reported results for the first quarter ended March 31, 2007. Revenue for the first quarter of 2007 was $80,000 compared to $25,000 for the quarter ended March 31, 2006. Revenue in 2007 and 2006 includes recognition of deferred revenue related to two license agreements.

Dendreon's total operating expenses for the three months ended March 31, 2007 were $32.0 million compared to $25.6 million for the same period in 2006. Operating expenses for the three months ended March 31, 2007 included purchases of commercial scale quantities of the antigen used in connection with Dendreon's lead investigational product, Provenge(R) (sipuleucel-T), of $6.3 million.

The net loss for the quarter ended March 31, 2007 was $30.9 million, or $0.38 per share which, included $0.08 per share associated with the commercial antigen purchases, compared to a net loss of $24.4 million, or $0.34 per share, for the same quarter a year ago.

Cash, cash equivalents, short-term, and long-term investments at March 31, 2007 totaled $88.5 million compared to $121.3 million at December 31, 2006.


 
    Recent Events: 
    -- The U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene 
       Therapies Advisory Committee review of Dendreon's Biologics License 
       Application (BLA) for the use of PROVENGE in the treatment of patients 
       with asymptomatic, metastatic, androgen-independent (also known as 
       hormone refractory) prostate cancer was held on March 29, 2007. 
          - The Advisory Committee was unanimous (17 yes, 0 no) in its opinion 
            that the submitted data established that PROVENGE is reasonably 
            safe for the intended population and the majority (13 yes, 4 no) 
            believed that the submitted data provided substantial evidence of 
            the efficacy of PROVENGE in the intended population. 
    -- The Company received a Complete Response Letter, commonly referred to 
       as an "approvable letter," on May 8, 2007 from the FDA regarding its 
       BLA for PROVENGE. 
          - The FDA has requested additional clinical data in support of the 
            efficacy claim contained in the BLA.  The Company is seeking a 
            clarification from the FDA as to the nature of the data that is 
            being requested. 
          - The FDA has requested additional information with respect to the 
            chemistry, manufacturing and controls (CMC) section of the BLA, 
            which the Company believes it can supply to the FDA in a timely 
            manner. 
    -- The Company continues to have strong patient enrollment in its Phase 3 
       IMPACT study, which is on track for completion of enrollment this year. 
    Conference Call Information 
    Time: 4:30 pm ET / 3:30 pm CT / 2:30 pm MT / 1:30 pm PT 
    Date: May 10, 2007 
    Dial-in: 1-866-293-8972 (domestic) or +1-913-312-1232 (international) 
    Webcast: www.dendreon.com (homepage and investor relations section) 

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 or +1-719-457-0820 for international callers; the conference ID number is 3324857. The replay will be available from 2:00 pm ET on Thursday, May 10th until 11:59 pm ET on Monday, May 14th. In addition, the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.

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 that harness the immune system to fight cancer. 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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle 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 outcome of the FDA's review of the Company's BLA submitted in November 2006 and the efficacy of PROVENGE to treat men suffering from prostate cancer. Factors that may cause such differences include, 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, risks associated with completing our ongoing clinical trials for PROVENGE and other product candidates, risks that we may lack the financial resources and access to capital to fund commercialization of PROVENGE and/or further required clinical trials, our dependence on relationships with third parties for components used in PROVENGE and services related to production of PROVENGE, 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.


SOURCE Dendreon Corporation


Monique Greer, Sr. Director, Corporate Communications of Dendreon Corporation, 
+1-206-829-1500 

http://www.dendreon.com/ 

Copyright (C) 2007 PR Newswire. All rights reserved ********************************************************************** As of Sunday, 05-06-2007 23:59, the latest Comtex SmarTrend? Alert, an automated pattern recognition system, indicated an UPTREND on 03-26-2007 for DNDN @ $4.99. For more information on SmarTrend, contact your market data provider or go to www.mysmartrend.com SmarTrend is a registered trademark of Comtex News Network, Inc. Copyright ? 2004-2007 Comtex News Network, Inc. All rights reserved.



Fiday...May 11, 2007.......Closing chart


 

[setravis]

This thread is dominated by DNDN....... 

So lets just drop the CTIC from the thread topic title,cause it is not worth the
time it takes to look at the chart.......

[la-onda]

not on my watchlist anymore....

fyi:
DNDN: UBS Securities Keeps @ Reduce; Cuts Tgt to $4.5 vs $9; Analyst Notes
Monday , May 14, 2007 12:55ET
Issuer: Dendreon Corporation (NasdaqNM: DNDN)
Analyst Firm:  UBS Securities Inc.
Ratings Action: REITERATION
Current Rating: Reduce
Target Price Action: DECREASE
Target Price: $4.50 (-50.00% from $9.00)
Analyst Comments: The firm comments on DNDN reaffirming that its SPA with the FDA for the IMPACT study indicates that the basis for the approval of Provenge may be the positive interim data on survival, anticipated in 2008. They noted, however, there are doubts regarding overall efficacy and the statistical robustness of the analysis. Provenge is expected to be launched earlier by 2011 and near-term financing risk is likely to exert pressure on the company's share price. The firm's EPS estimate for 2008 has been reduced from -$1.05 to -$1.14.

[setravis]

Press Release Source: Dendreon Corporation


Dendreon Announces Presentation of Data at American Urological Association Annual Meeting
Sunday May 20, 6:30 pm ET 
-Data May Support Use of PROVENGE(R) as Front-line Treatment in Advanced Prostate Cancer-


SEATTLE and ANAHEIM, Calif., May 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the presentation of data from an analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients who were initially treated with PROVENGE (sipuleucel-T) who then went on to receive docetaxel chemotherapy after disease progression. The data were presented today at the American Urological Association (AUA) Annual Meeting in Anaheim, California.


The abstract, titled "Advanced Prostate Cancer Patients who Receive Sipuleucel-T followed by Docetaxel Have Prolonged Survival" (#605), authored by Daniel P. Petrylak, M.D., associate professor of medicine at New York- Presbyterian Hospital at the Columbia University Medical Center, is based on an exploratory analysis conducted to assess the influence of the active cellular immunotherapy PROVENGE on the clinical outcome of patients who subsequently went on to receive docetaxel chemotherapy after primary treatment with PROVENGE. The analysis was conducted by evaluating data from two Phase 3 clinical trials of PROVENGE in patient with asymptomatic, metastatic, androgen-independent prostate cancer (AIPC).

"The results of this analysis suggest that the use of sipuleucel-T as a first-line treatment followed by the chemotherapy docetaxel upon disease progression may provide patients with a substantially prolonged survival benefit," said Dr. Petrylak. "This analysis provides valuable clinical insight as to how the treatment of men with advanced prostate cancer will likely evolve with the potential introduction of new products like sipuleucel- T that complement the currently available treatment regimens for men with advanced prostate cancer."

Study Design and Results

This analysis was conducted by evaluating data from two identically designed randomized Phase 3 trials (D9901 and D9902A; n=225) conducted in men with asymptomatic, metastatic, androgen independent prostate cancer. Survival analyses were performed on the subgroup of 82 patients in the trials that were documented to have received docetaxel chemotherapy following initial treatment with either PROVENGE or placebo.

According to the analysis, the patients who received initial treatment with PROVENGE followed by docetaxel had a median survival of 34.5 months compared to 25.4 months for those patients in the placebo arm who received treatment with docetaxel chemotherapy, a 9.1 month difference. In addition, an analysis of overall survival demonstrated that patients in the PROVENGE arm who received subsequent therapy with docetaxel had a 47 percent reduction in their risk of death compared to those in the placebo arm who received subsequent therapy with docetaxel (HR = 1.90, p-value = 0.023).

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 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease.

About PROVENGE

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

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 that harness the immune system to fight cancer. 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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has headquarters in Seattle and is traded on The Nasdaq Stock Market® under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.

Except for historical information, 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 a clinical trial for PROVENGE will not support our biologics license application, 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 biologics license application for a therapeutic, the risk that the results of existing clinical trials data or from additional clinical trials for PROVENGE or other products 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.

--------------------------------------------------------------------------------
Source: Dendreon Corporation

[tokyopua]

Got some DNDN now at 11
Ouch, had to get out at 10.20 

[tokyopua]

Got some DNDN now at 11
Ouch, had to get out at 10.20 

Closed at 8.55, lol.  I had the opportunity there for about all of a minute to sell the dog at $12 but that is how it goes sometimes chasing momentum, was lucky to get out bruised but not totally burned!

[Ares]

DNDN moving.
On paper, I got in at 8.32 this morning. Happy trading, Pls. do your own DD. Just want to point out that it recently broke yesterday's high of 8.40.