362 di 491
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24/10/2007 07:53
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simoncinimauro
N° messaggi: 342 -
Iscritto da: 09/4/2007
Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge® For Advanced Prostate Cancer
--FDA Has Agreed That Positive Survival Data from IMPACT Study Would Support Licensure of PROVENGE—
--Interim Survival Results Expected in Second Half of 2008--
SEATTLE, WA, October 23, 2007 – Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has completed enrollment of over 500 patients in the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo.
Earlier this year, following a positive recommendation from an outside panel of experts, Dendreon received a complete response letter from the U.S. Food and Drug Administration (FDA) that asked for additional evidence that would support the efficacy of PROVENGE. Subsequently, Dendreon received confirmation that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE.
"The completion of enrollment of over 500 patients into the IMPACT study is a major achievement for the organization, as the data from this trial may provide the FDA with the additional clinical data they need for the approval of PROVENGE," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Men with late stage prostate cancer currently have few appealing treatment options available to them. We believe PROVENGE has the potential to offer both oncologists and urologists a well tolerated treatment option for their patients that has the ability to extend survival."
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363 di 491
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24/10/2007 12:18
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xantos2
N° messaggi: 288 -
Iscritto da: 23/5/2007
Ciao a tutti,ciao Ivanoski,per il momento io dndn non l'ho neanche più monitorato,mi hanno detto che se le ho in carico 7,8/8,00 non mi devo preoccupare.La notizia bomba non la vogliono ancora dare,tutto è stato bloccato.Secondo me puoi lasciare una parte dell'investimento su dndn,sempre che non ti servano quei soldi,in modo tale da non perdere l'eventuale partenza.Se invece hai solo quelli,allora mio consiglio è girarli in altri titoli,tanto per il momento non farà grossi balzi in avanti.
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371 di 491
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07/11/2007 15:52
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xantos2
N° messaggi: 288 -
Iscritto da: 23/5/2007
CIAO simoncini,scusa ma ieri sono stato tutto il giorno impegnato e non ho potuto risponderti.Mi è stato riferito che non daranno nessuna notizia-bomba per il momento,come ti avevo già accennato,e che il calo di oggi è conseguenza del fatto che chi sperava in quella notizia ieri,oggi sta vendendo.Comunque mi dicono di non preoccuparmi se in carico 7,5-8 eu.Appena so qualcosa ti avviso,ciao
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378 di 491
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15/11/2007 22:48
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simoncinimauro
N° messaggi: 342 -
Iscritto da: 09/4/2007
Dendreon Reports Third Quarter 2007 Financial Results
- Management Will Host Conference Call at 1:30 PM ET -
SEATTLE, Nov. 15 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended September 30, 2007. Revenue for the third quarter of 2007 was $112,000 compared to $84,000 for the quarter ended September 30, 2006. Revenue for the nine months ended September 30, 2007 was $715,000 compared to $187,000 for the nine months ended September 30, 2006.
Dendreon's total operating expenses for the third quarter of 2007 were $19.8 million compared to $21.7 million in 2006. Dendreon's total operating expenses for the nine months ended September 30, 2007 were $75.2 million compared to $73.6 million for the same period in 2006.
The net loss for the quarter ended September 30, 2007 was $19.2 million, or $0.23 per share, compared to a net loss of $20.7 million, or $0.29 per share, for the quarter ended September 30, 2006. The net loss for the nine months ended September 30, 2007 was $72.3 million, or $0.88 per share, compared to $70.2 million, or $0.98 per share for the nine months ended September 30, 2006.
Cash, cash equivalents and short-term and long-term investments at September 30, 2007 totaled $138.8 million compared to $121.3 million at December 31, 2006.
Recent Highlights:
-- Completed enrollment of over 500 patients in the Phase 3 IMPACT
(IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as
D9902B) clinical trial of PROVENGE(R) (sipuleucel-T). Dendreon
received confirmation that the FDA will accept either a positive
interim or positive final analysis of overall survival from the IMPACT
study to amend the Biologics License Application (BLA) and support the
efficacy claim for PROVENGE.
-- Implemented a committed equity financing facility under which the
Company may sell up to $130 million of its registered common stock to
Azimuth Opportunity, Ltd. over an 18-month period. Dendreon is not
obligated to utilize any of the $130 million facility and remains free
to enter into and consummate other equity and debt financing
transactions.
-- Results from a Phase 1 study of NEUVENGE, an investigational active
cellular immunotherapy, were published in the August 20th issue of the
Journal of Clinical Oncology. The article highlighted the safety
profile, immune response and clinical activity of NEUVENGE in women
with HER2/neu-positive breast cancer who have failed standard therapy.
"We achieved an important milestone this quarter by completing enrollment of our Phase 3 IMPACT trial of PROVENGE, a therapy we believe has the potential to positively impact the lives of many prostate cancer patients who currently have few treatment options," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are grateful to the patients, clinical investigators and nurses who participated in this study. In addition, we would like to thank our vendors and suppliers, in particular the American Red Cross, Progenitor Cell Therapy and the Mayo Clinic, each of which provided high-quality, consistently excellent cell processing and service throughout the trial. We look forward to receiving interim results from this important study next year."
Conference Call Information
Dendreon will host a conference call today at 1:30 p.m. PT, 4:30 p.m. ET. To access the live call, dial 1-877-397-0235 (domestic) or +1 719-325-4876 (international). The call will also be audio webcast and will be available from the Company's website at http://www.dendreon.com under the "Investor/Webcasts and Presentations" 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 5547646. The replay will be available from 7:30 pm ET on Thursday, November 15 until 11:59 pm ET on Saturday, November 17. In addition the webcast will be archived for on-demand listening for 30 days at http://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 http://www.dendreon.com .
Except for historical information contained herein, 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, market demand for the Company's securities, pricing and other terms related to the sale of the notes, 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 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 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 http://www.sec.gov .
DENDREON CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Nine months ended
September 30, September 30,
2007 2006 2007 2006
Revenue $112 $84 $715 $187
Operating expenses:
Research and development 13,449 15,754 54,780 56,995
General and administrative 6,364 5,974 20,458 16,634
Total operating expenses 19,813 21,728 75,238 73,629
Loss from operations (19,701) (21,644) (74,523) (73,442)
Interest income 2,022 1,353 4,744 4,641
Interest expense (1,551) (452) (2,534) (1,354)
Net loss $(19,230) $(20,743) $(72,313) $(70,155)
Basic and diluted net
loss per share $(0.23) $(0.29) $(0.88) $(0.98)
Shares used in
computation of basic
and diluted net
loss per share 82,965 71,320 82,356 71,236
September 30, December 31,
2007 2006
Balance Sheet Data:
Cash and cash
equivalents $90,950 $60,964
Short-term investments 30,184 45,492
Long-term investments 17,694 14,827
Total assets 181,059 163,643
Convertible notes 85,250 -
Total stockholders' equity 64,611 125,717
SOURCE Dendreon Corporation
CONTACT: Jennifer Cook Williams, Investor Relations of Dendreon Corporation, +1-206-829- 1500 -0- Nov/15/2007 21:17 GMT
Last Updated: November 15, 2007 16:17 EST
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379 di 491
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16/11/2007 10:12
0
xantos2
N° messaggi: 288 -
Iscritto da: 23/5/2007
Ciao ragazzi,tutto quello che vi posso dire e che mi è stato riferito,è che per il momento si muoverà lateralmente o con piccole oscillazioni,ma come già detto a 7,5/8 ci ritorna sempre.Stanno solo aspettando di dare "la notizia".Forse la fanno sciendere per caricare a un costo minore,e poi farla partire.Certo converrebbe lasciarne lì un pò,perchè nel momento in cui daranno la notizia,il titolo sarà già schizzato,e continuano a dirmi che potrà essere domani come tra un mese.Io ne ho rimesse in pt a questi prezzi,speriamo mi arrivi la telefonata tanto attesa.Ciao e buona giornata.
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