Dendreon Completes Submission of Biologics License Application for PROVENGE
SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.
The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.
"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. "We look forward to working with the FDA to potentially make PROVENGE the first active cellular immunotherapy to be licensed in the United States."
PROVENGE is available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT (PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant Active Cellular immunotherapy). For more information regarding these studies, visit www.clinicaltrials.gov.
About PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. 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.
About Prostate Cancer
According to the American Cancer Society, 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. An estimated 192,280 new cases are expected to be diagnosed in 2009. Approximately 27,360 men are expected to die this year from the disease.
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.
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 the FDA's actions with respect to the BLA and whether the FDA determines to convene an advisory committee to review the BLA; progress on the commercialization efforts for PROVENGE, including the expansion of Dendreon's manufacturing capacity and other necessary infrastructure; success in the hiring of additional personnel to support business growth and expansion; the outcome of pre-approval inspection of Dendreon's expanded manufacturing facility; and requisite receipt of FDA licensure for marketing of PROVENGE and the risk that additional capital could be needed in the future for the potential 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.
Contact Information:
Katherine Stueland
Vice President, Corporate Communications and Investor Relations
206-829-1522
[email protected]
SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.
The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.
"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. "We look forward to working with the FDA to potentially make PROVENGE the first active cellular immunotherapy to be licensed in the United States."
PROVENGE is available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT (PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant Active Cellular immunotherapy). For more information regarding these studies, visit www.clinicaltrials.gov.
About PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. 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.
About Prostate Cancer
According to the American Cancer Society, 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. An estimated 192,280 new cases are expected to be diagnosed in 2009. Approximately 27,360 men are expected to die this year from the disease.
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.
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 the FDA's actions with respect to the BLA and whether the FDA determines to convene an advisory committee to review the BLA; progress on the commercialization efforts for PROVENGE, including the expansion of Dendreon's manufacturing capacity and other necessary infrastructure; success in the hiring of additional personnel to support business growth and expansion; the outcome of pre-approval inspection of Dendreon's expanded manufacturing facility; and requisite receipt of FDA licensure for marketing of PROVENGE and the risk that additional capital could be needed in the future for the potential 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.
Contact Information:
Katherine Stueland
Vice President, Corporate Communications and Investor Relations
206-829-1522
[email protected]
2/11 2009 16:46 alpehue 0
21266 Ja HYA den takker jeg dig for,
- selv om det var lidt sent, jeg fik øje på substansen i dine gode råd her
Min GEN-udveksler aktie.
Jeg er mere sikker på denne end på GEN.
- selv om det var lidt sent, jeg fik øje på substansen i dine gode råd her
Min GEN-udveksler aktie.
Jeg er mere sikker på denne end på GEN.
Aktien har ligget været i langvarig optrend siden 14. april hvor den steg kraftigt af årsager jeg ikke har dykket ned i. Den 14. april lukkede aktien således i kurs 16.99 og er efterfølgende steget langsomt men sikkert til kurs 28.61 som den lukkede i her den 6. november. På den mere korte bane ligger aktien og handler mellem ca. 26 og 30. Det bliver derfor spændende og se hvornår aktien formår at bryde opover 30 og fortsætte stigningerne.
Rent teknisk er aktien i køb udfra Parabolsk SAR, MACD, Stochastic Oscillator og MA20 ligger over MA50 samtidig med at kursen handler over begge glidende gennemsnit. Har vedhæftet en kursgraf på dagsniveau.
Porter
Rent teknisk er aktien i køb udfra Parabolsk SAR, MACD, Stochastic Oscillator og MA20 ligger over MA50 samtidig med at kursen handler over begge glidende gennemsnit. Har vedhæftet en kursgraf på dagsniveau.
Porter
11/11 2009 18:01 fistandanti 021695 Mon ikke modstanden ved 30 brydes når DNDN får offentliggjort en partner til lanceringen af Provenge på det euroæpiske markedet, hvilket flere analytikerne venter på.
Overtagelsesrygter holder en hånd under kursen - positiv hype nyder DNDN godt af i øjeblikket modsat gen. Men man skal ikke lang tid tilbage før majoriteten af analytikerene var skeptiske overfor DNDN, en gik hvis så vidt at ændre sit kurstarget fra 2 dollars til 32 !! Det kan man så reflektere lidt over i disse tider hvor analysehuse sabler gens kurs ned.
Ps : Den voldsomme kursstigning tilbage i april skyldtes positive fase 3 resultater for deres cancervaccine Provenge.
Overtagelsesrygter holder en hånd under kursen - positiv hype nyder DNDN godt af i øjeblikket modsat gen. Men man skal ikke lang tid tilbage før majoriteten af analytikerene var skeptiske overfor DNDN, en gik hvis så vidt at ændre sit kurstarget fra 2 dollars til 32 !! Det kan man så reflektere lidt over i disse tider hvor analysehuse sabler gens kurs ned.
Ps : Den voldsomme kursstigning tilbage i april skyldtes positive fase 3 resultater for deres cancervaccine Provenge.
Jeg frygtede i går sent, at et kursfald kunne være reaktionen på emissionsbehovet. Selvom det går til udgifter med fabrik og produktion.
Har derfor idag valgt at nedbringe og ser frem til kursen de kommende dage og uger.
nye aktier 15 mio + ekstra 2,25
I dag vist ca 115 mio ?
http://www.zacks.com/stock/news/28081/Dendreon+Raising+Money+-+Analyst+Blog
Har derfor idag valgt at nedbringe og ser frem til kursen de kommende dage og uger.
nye aktier 15 mio + ekstra 2,25
I dag vist ca 115 mio ?
http://www.zacks.com/stock/news/28081/Dendreon+Raising+Money+-+Analyst+Blog
7/1 2010 15:30 fistandanti 024229 DNDN har lagt godt ud i år med stigning over 10% - spændende at følge om den lukker over de 30 denne gang.
At tænke sig at den var i 2-4 dollar for mindre end et år siden....
7/4 2010 15:17 1970 027963 Så er vi på 40
Burde måske tage lidt profit nu, men jeg kan ikke lade være med at vente lidt endnu...
Burde måske tage lidt profit nu, men jeg kan ikke lade være med at vente lidt endnu...
7/4 2010 15:54 cyber 027970 I mine øjne kan mange takke Hya for den focus og indsigt, hun gennem flere år har holdt på DNDN, og bredt ud til andre. Hurra for Hya og hendes vedvarende tro på DNDN. Min timing har ikke været god, lad det være sagt.
8/4 2010 14:05 Hya 028008 http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100408005283&newsLang=en
her kan man lige læse lidt om flere i branchen
her kan man lige læse lidt om flere i branchen
20/4 2010 19:10 1970 028355 mener at 40 er en fin kurs nu og 50 ved evt. godkendelse i løbet af måneden..
http://www.forbes.com/2010/04/14/downgrades-dndn-twx-pot-mos-marketnewsvideo.html?partner=yahootix
Citigroup downgraded shares of Dendreon from buy to hold citing valuation. The company is waiting for regulatory approval for its new prostate cancer drug and analyst Lucy Lu wrote in her report that the shares are currently "priced to perfection". With the downgrade, Citigroup raised its price target to $40 per share and noted that the price could climb to $50 per share if the drug is approved.
Shares of Dendreon ( DNDN - news - people ) were trading close to even this morning, up just a few pennies.
http://www.forbes.com/2010/04/14/downgrades-dndn-twx-pot-mos-marketnewsvideo.html?partner=yahootix
Citigroup downgraded shares of Dendreon from buy to hold citing valuation. The company is waiting for regulatory approval for its new prostate cancer drug and analyst Lucy Lu wrote in her report that the shares are currently "priced to perfection". With the downgrade, Citigroup raised its price target to $40 per share and noted that the price could climb to $50 per share if the drug is approved.
Shares of Dendreon ( DNDN - news - people ) were trading close to even this morning, up just a few pennies.
23/4 2010 14:54 1970 028470 WINNER: Provenge for Prostate from Dendreon
Den pris tager vi gerne med..:
http://www.terrapinn.com/2010/wvcdc/theAwards.stm
Den pris tager vi gerne med..:
http://www.terrapinn.com/2010/wvcdc/theAwards.stm
28/4 2010 15:00 1970 028666 Dendreon Watch 2010 (and Why You Should Ignore It)
http://www.fool.com/investing/high-growth/2010/04/26/dendreon-watch-2010-and-why-you-should-ignore-it.aspx
og lidt "hyggelæsning" om kursmanipulationen i DNDN - link taget fra indlæg under forrige link.
http://www.deepcapture.com/wp-content/uploads/2009/10/story-of-dendreon.pdf
http://www.fool.com/investing/high-growth/2010/04/26/dendreon-watch-2010-and-why-you-should-ignore-it.aspx
og lidt "hyggelæsning" om kursmanipulationen i DNDN - link taget fra indlæg under forrige link.
http://www.deepcapture.com/wp-content/uploads/2009/10/story-of-dendreon.pdf
7/4 2010 17:50 Hya 027977 Ja mine aktier er jo gratis - og jeg har taget gevinsten utallige gange - så jeg lukker øjnene og satser på at det bliver godkendt inden maj 2010
og jeg har ikke sl på fordi jeg forventer bearraid eller andre ufine trix i aktien før afklaringen
og sker det mens jeg er online så køber jeg på dippet hvis det kommer!
Kh Hya
og jeg har ikke sl på fordi jeg forventer bearraid eller andre ufine trix i aktien før afklaringen
og sker det mens jeg er online så køber jeg på dippet hvis det kommer!
Kh Hya
