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DNDN

97 Posts
Pagina: «« 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. [verwijderd] 2 maart 2010 17:28
    Wat was me dit vandaag bij DNDN.De geruchtenmolen draait hier nu op volle toeren.Vele beleggers die met een stop loss werken zijn nu hun stukken kwijt.
    Dendreon Corporation
    Mar. 1, 2010 Market Close: $ 32.51

    Was voorbeurs even tot -12% gezakt door dit bericht hier.Iets later werd dit bericht ontkend.
    Pre-Market
    Last: $ 30.98
    High: $ 31.95
    Low: $ 28.56
    Volume: 2,040,663

    1)08:11 DNDN

    Dendreon lower on concerns of a potential FDA advisory panel
    Shares of Dendreon are trading lower following comments by a boutique firm that raised concerns of a potential FDA advisory panel on Provenge. We note, however, that there has been continued investor concerns regarding an advisory panel and just yesterday Leerink said its checks reveal that Provenge's review process has gone beyond the point where the FDA would have made a decision to convene a panel. Leerink rates shares an Outperform.

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

    2)09:44 EDT DNDN
    Dendreon says no indication of FDA panel review for Provenge, Dow Jones reports

    10:11 EDT DNDN
    Dendreon says it has no indication of FDA panel, Bloomberg reports

    10:06 EDT DNDN
    FDA spokeswoman says Dendreon's Provenge won't face advisory panel

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

    3)Dendreon Corporation(NasdaqGM: DNDN)

    Real-Time: $34.84 Up 2.33 (+7.17%)
    Prev Close: 32.51
    Open: 31.03
    Day's Range: 30.81 - 35.27
    52wk Range: 2.55 - 35.27
    Volume: 20,816,502

    March 2, 2010 10:37 AM EST

    CNBC reports that two FDA officials said Dendreon (Nasdaq: DNDN) Provenge "will not" go before a FDA advisory panel.

    After trading down 9% earlier, shares of DNDN are up 8% currently.

    www.dailyfinance.com/quotes/dendreon-...

    Mvg,
    Skip

  2. [verwijderd] 4 maart 2010 03:16
    Nabeurs net op geen $35 afgesloten.
    After Hours: $34.98 Up 1.36 (+4.05%)

    UPDATE 2-Dendreon: Provenge boosts survival 40 pct

    LOS ANGELES, March 3 (Reuters)
    - Updated trial results show that an experimental cancer vaccine developed by Dendreon Corp improved three-year survival of patients with advanced prostate cancer by 40 percent compared with a placebo.

    Dendreon shares rose 4.05 percent in after-hours trade.

    The results, based on just over three years of follow-up, confirm earlier 34-month data presented last year, which showed that the drug improved survival by 38 percent.

    Patients in the 512-patient study who received Dendreon's Provenge lived an average of 4.1 months longer than those who were given a placebo, according to the latest tally announced by the company on Wednesday.

    Unlike traditional vaccines that prevent disease, Provenge treats it by stimulating the body's own immune system to attack cancer cells.

    It is produced by taking cells from a patient's tumor, incorporating them into a vaccine, then returning them to a physician to be injected back into the patient.

    The U.S. Food and Drug Administration is slated to decide by May 1 whether to approve Provenge for treating advanced prostate cancer.

    Prostate cancer is the most common cancer in American men aside from skin cancers, according to the American Cancer Society.

    More than one million men have the disease in the United States and one in six men will be diagnosed with prostate cancer during their lifetime.

    If approved, Provenge, which is administered in three doses at two-week intervals, would be the first cancer immunotherapy on the market.

    Adverse events seen in patients taking Provenge were chills, fever and headache that lasted one to two days following infusion, which is seen as an enormous advantage over the debilitating side effects typically seen with chemotherapy.

    Seattle-based Dendreon said the latest clinical trial data will be presented on Friday at a meeting of the American Society of Clinical Oncology in San Francisco.

    Skip
    Shares of Dendreon rose to $34.98 after closing at $33.62 on Nasdaq.

    www.dailyfinance.com/quotes/dendreon-...

    finviz.com/screener.ashx?v=341&f=ind_...
  3. [verwijderd] 12 maart 2010 20:21

    Real-Time: $37.08 Up 1.07 (2.97%)
    Change: Up 0.36 (0.99%)
    Prev Close: $36.01
    Day's Range: $36.36 - $36.79
    52wk Range: $2.80 - $37.05

    Dendreon (DNDN): There's no keeping Dendreon out of the news, Robert Baird initiating it Outperform with a $48 price objective. The broker sees significant upside potential ahead of Provenge's likely launch. See also Dendreon and the Prostate Cancer Battle.

    www.minyanville.com/businessmarkets/a...

    Skip
  4. [verwijderd] 14 april 2010 14:35
    quote:

    flipke 12 schreef:

    Geruchten op problemen voor de FDA uitspraak volgende maand.
    Heb je een link waar dit zwart op wit wordt geschreven?

    Weet hier bij DNDN enkel dat de koers hier voorbeurs even van zijn slotkoers $38.83 naar $36.02 was gezakt met amper 100 aandelen op een totaal van 700 verhandelde aandelen en dit allemaal omdat Citibank zijn koopadvies naar houden heeft gebracht doch het koersdoel van $35 naar $40 heeft gebracht.Er moet hier nu wel eenmaal wat leven in de brouwerij komen nu we zowat op 14 dagen staan van een eventuele goedkeuring van de FDA.

    www.streetinsider.com/Downgrades/Citi...

    Extended Hours
    $38.29 -0.54 -1.39%

    Skip

  5. [verwijderd] 14 april 2010 14:39
    quote:

    skippy44 schreef:

    [quote=flipke 12]
    Geruchten op problemen voor de FDA uitspraak volgende maand.
    [/quote]

    Heb je een link waar dit zwart op wit wordt geschreven?

    Weet hier bij DNDN enkel dat de koers hier voorbeurs even van zijn slotkoers $38.83 naar $36.02 was gezakt met amper 100 aandelen op een totaal van 700 verhandelde aandelen en dit allemaal omdat Citibank zijn koopadvies naar houden heeft gebracht doch het koersdoel van $35 naar $40 heeft gebracht.Er moet hier nu wel eenmaal wat leven in de brouwerij komen nu we zowat op 14 dagen staan van een eventuele goedkeuring van de FDA.

    www.streetinsider.com/Downgrades/Citi...

    Extended Hours
    $38.29 -0.54 -1.39%

    Skip

    Nee, dacht ik zomaar omdat ik hem zag zakken in de pre, heb ook niets gezien.
  6. [verwijderd] 14 april 2010 17:06
    quote:

    flipke 12 schreef:

    [quote=skippy44]
    [quote=flipke 12]
    Geruchten op problemen voor de FDA uitspraak volgende maand.
    [/quote]

    Heb je een link waar dit zwart op wit wordt geschreven?

    Weet hier bij DNDN enkel dat de koers hier voorbeurs even van zijn slotkoers $38.83 naar $36.02 was gezakt met amper 100 aandelen op een totaal van 700 verhandelde aandelen en dit allemaal omdat Citibank zijn koopadvies naar houden heeft gebracht doch het koersdoel van $35 naar $40 heeft gebracht.Er moet hier nu wel eenmaal wat leven in de brouwerij komen nu we zowat op 14 dagen staan van een eventuele goedkeuring van de FDA.

    www.streetinsider.com/Downgrades/Citi...

    Extended Hours
    $38.29 -0.54 -1.39%

    Skip

    [/quote]Nee, dacht ik zomaar omdat ik hem zag zakken in de pre, heb ook niets gezien.
    Terug in het groen.

    Real-Time: $39.01 Up 0.18 (+0.46%)
  7. [verwijderd] 29 april 2010 18:45
    quote:

    skippy44 schreef:

    Halted op $45.51 nadat de koers plotseling opveerde.

    NASDAQ Last Sale
    45.51 5.89 +14.87%
    Volume
    3,644,940
    Previous Close
    $ 39.62
    Today's High
    $ 47.3200
    Today's Low
    $ 39.4000

    Skip
    05/01/2010 DENDREON CORP DNDN Provenge (BLA) FDA decision on Provenge for treatment of prostate cancer ............. komt er al eerder nieuws dan?
  8. [verwijderd] 29 april 2010 18:56
    quote:

    pip 1 schreef:

    [quote=skippy44]
    Halted op $45.51 nadat de koers plotseling opveerde.

    NASDAQ Last Sale
    45.51 5.89 +14.87%
    Volume
    3,644,940
    Previous Close
    $ 39.62
    Today's High
    $ 47.3200
    Today's Low
    $ 39.4000

    Skip
    [/quote]05/01/2010 DENDREON CORP DNDN Provenge (BLA) FDA decision on Provenge for treatment of prostate cancer ............. komt er al eerder nieuws dan?
    Gezien 1 Mei op een zaterdag is zat de kans er in dat er vandaag,morgen nieuws zou lekken.Anders was het wachten tot ma 4 mei.Gezien deze plotse spike naar boven toe doet natuurlijk het beste vermoeden,alleen wacht ik hier op een officiële bevestiging.

    Hier als de bron juist is.

    * Dendreon's (DNDN) Provenge Approved by FDA; Stock Just Halted

    More News related to FDA
    April 29, 2010 12:34 PM EDT

    Dendreon's (Nasdaq: DNDN) Provenge has been approved, according to an FDA spokesperson. The stock was just halted.
    ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Dendreon volatility collapses as shares rally into trading halt
    Dendreon is halted up $5.89 to $45.51. DNDN's provenge prostate-cancer vaccine was approved by the FDA, Reuter's reports. Call option volume of 20,172 contracts compares to put volume of 28,480. May option implied is at 84, below a level of 160 from this morning according to Track Data, suggesting decreasing price movement.

    Skip
  9. [verwijderd] 29 april 2010 19:48
    Van de FDA site.

    FDA NEWS RELEASE

    For Immediate Release: April 29, 2010
    Media Inquires: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov

    FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

    The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

    Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

    Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

    “The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

    Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

    The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

    Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

    Provenge is manufactured by Seattle-based Dendreon Corp.

    www.fda.gov/NewsEvents/Newsroom/Press...

    Skip

  10. [verwijderd] 1 juli 2010 02:18


    Nu nabeurs nog op $26,69 (-17,45%) met een low van $24,51.
    After Hours Volume: 5,031,344

    Read more: www.nasdaq.com/aspxcontent/ExtendedTr...

    Deze overdreven? reactie komt er na dit nieuws.

    Dendreon Plunging After Hours (DNDN)

    Shares of Dendreon (NASDAQ: DNDN) are plunging in the after hours session on news that the Center for Medicare & Medicaid Services (CMS) has opened a national coverage determination to "determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act."

    This appears to be a Medicare/Medicaid reimbursement issue as it relates to Provenge treatment costs. If CMS determines that Provenge is both reasonable and necessary, then patients will be reimbursed. If not, Provenge treatment, which costs $93,000 for a full course, will not be covered.

    The shares have currently lost more than 18% to $26.50 in the late trading session. According to the press release at cms.gov, "CMS received informal inquiries for a national coverage determination (NCD) for autologous cellular immunotherapy treatment of prostate cancer. This interest arose upon the recent FDA approval of the Sipuleucel T treatment regimen, marketed as Provenge®."

    The formal request was accepted and review initiated today, and the press release gives the "Expected NCA Completion Date" as 6/30/2011. There will be a public comment period starting today, which will last a month.


    www.dailyfinance.com/related/dendreon...

    Skip

  11. [verwijderd] 1 juli 2010 14:56
    Er zullen zich weer vele beleggers bekocht voelen na wat zich nabeurs heeft afgespeeld.

    Pre-Market Last:

    Net / % Change $ 28.18 -4.15 (-12.84%) Pre-Market High: $ 28.46
    Pre-Market Volume: 1,280,892
    Pre-Market Low: $ 26.74

    DNDN staat nu al bol van het nieuws.

    #
    Thursday, July 01, 2010
    #
    Morgan Joseph Lowers Estimates On Dendreon (DNDN), Sees Pricing Cuts
    8:45:27 AM View all Related Articles > | StreetInsider.com

    #
    Dendreon weakness creates buying opportunity, says Rodman & Renshaw
    8:40:18 AM | Theflyonthewall.com
    #
    The Twitter-24/7 Wall St. Stock Market Report 7.1.2010 The Wisdom Of Crowds
    8:26:06 AM | 24/7 Wall Street
    #
    Dendreon weakness an overreaction, says Canaccord
    8:18:10 AM | Theflyonthewall.com
    #
    Leerink: Unlikely CMS will not cover Dendreon's Provenge
    7:48:06 AM | Theflyonthewall.com
    #
    Dendreon volatility elevated; government begins Provenge analysis
    7:37:34 AM | Theflyonthewall.com
    #
    Dendreon makes statement on CMS National Coverage Analysis
    6:11:53 AM | Theflyonthewall.com

    www.dailyfinance.com/headlines/dendre...

    $ 28.35 -3.98 (-12.31%)

    Skip
  12. [verwijderd] 13 juli 2010 16:39
    quote:

    svenhedin schreef:

    Als dit geen mooi instapmoment is dan weet ik het niet meer.
    [/quote]

    [quote=crackedtooth]
    DNDN 27.15

    www.iex.nl/forum/post.asp?forum=23&to...

    De ene een dag vroeger dan de andere maar ondertussen al zo een $ 6 hersteld
    (DNDN $33.09 Up +0.64 +1.97%) maar nog ver weg van de opgegeven koersdoelen.

    Needham & Company Reiterates a 'Buy' Rating Dendreon (DNDN); 2Q10 Earnings Preview.

    Needham & Company reiterates a 'Buy' rating Dendreon Corporation (Nasdaq: DNDN), price target $62.

    Needham analyst says, "We have adjusted our revenue projections downwards for 2010, but upwards for 2011 to reflect our belief that the PROVENGE sales ramp may be more gradual during the first few quarters and may accelerate towards mid-2Q11 as additional manufacturing facilities start production. Our new revenue estimates are $5.3MM (was $8.6MM) for 2Q10, $22.4MM (was $26.8MM) for 3Q10, $43.2MM (was $42.6MM) for 4Q10, $71MM (was $78MM) for 2010, and $362MM (was $263MM) for 2011. While revenue represents a quantifiable figure for assessment during the PROVENGE launch, we believe that 2010 is really about “getting it right,” in terms of PROVENGE manufacturing, delivery, ease of use, and reimbursement."

    To see all the upgrades/downgrades on shares of DNDN, visit our Analyst Ratings page.

    www.streetinsider.com/stock_lookup_ne...

    Skip

  13. [verwijderd] 1 maart 2011 14:35
    Dendreon Corporation (NASDAQ: DNDN) reports after the close on Tuesday. Our take is that investors will be looking for guidance over real results as there are still small numbers generated so far due to what is a minimal production scale of Provenge. Prior 2011 guidance was promised to be very back-end loaded and that poses risks if there are any delays as it ramps up capacity. Another outstanding issue is the reimbursement rates and the use of on-label versus off-label use. Thomson Reuters has estimates of -$0.49 EPS and $24.68 million in revenues. For the current quarter still ongoing, Thomson Reuters has estimates of -$0.59 EPS and $29.44 in revenues. With shares around $33.70, its 52-week range is $25.78 to $57.67 and it closed out 2010 at $34.92.

    Long op Dndn
    Mvg;
    Skip
97 Posts
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