Beleggen.nl
Uitgebreid zoeken
Markt MonitorMarkt Monitor

BioPharma Terug naar discussie overzicht

Mooi instap moment Dendreon

1.743 Posts
Pagina: «« 1 ... 51 52 53 54 55 ... 88 »» | Laatste | Omlaag ↓
  1. [verwijderd] 22 april 2007 09:34

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    www.thestreet.com/_googlen/newsanalys...

    Dit gaat niet om Dendreon,maar om een klein bedrijf met mogelijkheden,en ook met een cancer drug middel.

    De vergelijkingen zijn er wel tussen die twee,en misschien kan de een voordeel doen bij de ander(koersverloop).

    Met vriendelijke groet.
  3. [verwijderd] 23 april 2007 17:22

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    quote:

    psycho-pharma schreef:

    Op de weg terug omhoog (raar taaltje, dat Nederlands).
    15.90 (++ 80 cents, 5,4%)

    P.
    ook leuk tradersaandeel, was zelf helaas weg
  4. [verwijderd] 23 april 2007 19:01

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Gaat lekker vandaag. Bied 16.71, laat 16.73 inmiddels.
    Terug naar de $25? Lijkt me logisch na al dat geshort vanaf $25.
    Nieuwe posities innemen straks....wordt lachen trouwens als approval al eerder dan de 15e mei komt.

    Ik houd ze gewoon vast tot na de 15e.
  10. [verwijderd] 24 april 2007 22:46

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    quote:

    Eisbear schreef:

    Hij krabbelt weerop Psycho richting 15 mei!
    Ja Knut, maar ik moet vanaf morgen tot zeker 4 mei voor zaken naar Chicago. Ik zal dan maar weinig tijd hebben om te kijken en te posten.
    Ik hoop niet, dat de approval komende week valt en ik er pas 3 dagen later achter kom.

    Dus Knut, hou het schip drijvend!!

    Psycho
  12. [verwijderd] 24 april 2007 23:29

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Een uur geleden.

    By Adam Feuerstein
    Senior Writer
    4/24/2007 4:24 PM EDT

    www.thestreet.com/_tsccom/newsanalysi...

    The latest on Dendreon (DNDN - Cramer's Take - Stockpickr - Rating): We still wait for the Food and Drug Administration to render its decision on Provenge, which is expected on or before May 15.

    My best guess remains that the agency will
    approve
    the prostate cancer drug.
    And to be clear: Approval, to me, means the FDA will not require Dendreon to submit additional proof of Provenge's efficacy before allowing the drug to be marketed. Additional clinical data on the drug will be necessary only as a post-marketing commitment.

    In the past couple of days, sell-side analysts at Banc of America Securities and JMP Securities have both come out favoring approval as the most likely outcome of the May 15 decision. Previously, both analysts were more skeptical about Provenge's chances.

    Many readers have asked if my thinking about Provenge has changed. No. But am I nervous about my call? Yes.

    Several people also have asked if I've updated my revenue projections for Provenge, and if not, why not, since they believe I'm way too conservative with my peak sales forecast ($1 billion in the U.S.) and my Dendreon price target of $27.

    There will be plenty of time to update Provenge numbers when (or if) the drug is approved. At this point, I'm very comfortable where I stand. Given the controversial nature of the Provenge data, I want to see the drug's label and get a sense of how urologic oncologists and medical oncologists view it. I believe that will tell us a lot about how well Provenge launches.

    With that in mind, if Provenge is approved on May 15, a couple of important events for investors will be the annual meeting of the American Urological Association (May 19-24) and the American Society of Clinical Oncology meeting (June 1-5). One of or both of these medical confabs could serve as Provenge's coming-out party.

  16. [verwijderd] 27 april 2007 17:05

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Dendreon Short Sellers Bet Drug Won't Win Approval (Update1)

    By Luke Timmerman

    April 27 (Bloomberg) -- Dendreon Corp. shares are being sold short at a record pace as some investors bet the company's experimental prostate cancer drug will fail to win approval from U.S. regulators.

    About 44 percent of Dendreon shares in mid-April were borrowed stock sold short, in anticipation of being replaced at a lower price, according to Nasdaq Stock Market data compiled by Bloomberg. That's a big bet against a stock that has tripled since March 29, when advisers to the Food and Drug Administration recommended the medicine.

    The drug, called Provenge, is the first of a new class designed to trigger the body's immune system to attack tumors. While Provenge prolonged lives of patients with advanced prostate cancer in one study presented to the panel, the drug didn't meet the trial's primary goal of slowing the spread of the disease.

    ``Some people are assuming the FDA won't listen to the panel'' because of the discrepancy in the study findings, said David Miller, president of Biotech Stock Research, an independent equity research firm in Seattle.

    The short-selling is up 28 percent from mid-March and double the amount in January. It's the second-biggest increase on the Nasdaq this month, after ON Semiconductor Corp., a maker of computer chips in Phoenix.

    Shares of Seattle-based Dendreon fell 24 cents, or 1.6 percent, to $15.21 at 9:48 a.m. New York time in Nasdaq Stock Market composite trading. The shares have almost quadrupled since Jan. 1, the best performance in the Nasdaq Biotechnology Index.

    Dendreon says it expects to hear May 15 whether Provenge will be released for use in the U.S. The company didn't respond to requests for comment on short-selling of the stock.

    Advisory Panel

    The FDA, while usually following the advice of advisory panels of scientists and doctors, isn't required by law to do so. Short sellers say the FDA may counter the advisers' ruling and hold off approving Provenge until results come in from another company-sponsored study. Dendreon has said that trial, measuring survival of 500 men with advanced prostate cancer, could take until 2010 to produce results.

    ``The short data says to me that people do not believe the panel's decision will be mirrored by the FDA,'' said Jonathan Aschoff, an analyst with Brean Murray Carret & Co. in New York, in a telephone interview. He has rated Dendreon shares ``sell'' since November 2004 and doesn't own any.

    The stock's price surge reflects the lack of good treatments for advanced forms of the cancer, which is often lethal once it spreads beyond the prostate. The disease kills 27,000 men in the U.S. a year. Doctors say they often try treating terminal patients with Taxotere, a drug from Paris-based Sanofi-Aventis SA. That medicine has side effects and limited usefulness.

    $1 Billion in Sales

    Provenge will be Dendreon's first product and may generate $1 billion a year in sales if approved by the FDA. Dendreon, founded in 1992, is trying to be the first drugmaker to market a new class of experimental medicines scientists are developing that stimulate the body's immune system to attack cancer.

    The company began its final-stage study in prostate cancer patients in 2000. Its only other product in clinical development is an immune-stimulator against breast cancer. Dendreon had an accumulated deficit of $392 million through the end of 2006, according to its annual report.

    Short-sellers may be betting that the FDA won't go along with the panel because of the conflicting clinical trial results. Dendreon's own statistical consultant told the advisory panel on March 29 that the research data is ``less than perfect.''

    Longer Survival

    Dendreon's first trial of 127 men showed that patients on Provenge lived a median 25.9 months, compared with 21.4 months for those on a placebo. A second trial of 98 men showed a median survival of 19 months, compared with 15.7 months for those taking a placebo. That finding wasn't valid because it didn't reach a statistical threshold, the company said.

    Both studies failed to demonstrate the drug slowed the cancer's spread, which was their primary goal. Dendreon says the measurement of whether Provenge was slowing the cancer's progress may have been carried out too early in the studies to detect the drug's ability to generate an attack by the immune system.

    Dendreon supporters say the chances of Provenge winning approval are good, given limited treatment options for the disease. The FDA can require additional trials after the drug goes to market if it wants more evidence it works, said Charles Duncan, an analyst with JMP Securities in New York, in a note to clients April 24.

    The first three of the 17 FDA panelists who were polled voted against recommending approval. The entire panel later voted 13-4 to recommend approval after the definition of the drug's effectiveness was changed by FDA staffers who analyzed the drug studies.

    William Ho, an analyst with Bank of America Securities in New York, told clients in a note April 24 that he expects FDA approval. He said the staff's revised definition of the drug's effectiveness was designed to ``lower the bar'' in evaluating Provenge.

    To contact the reporter on this story: Luke Timmerman in San Francisco ltimmerman@bloomberg.net .

    Last Updated: April 27, 2007 09:50 EDT
    www.bloomberg.com/apps/news?pid=20601...

    Met vriendelijke groet.
  19. [verwijderd] 27 april 2007 17:53

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Ik heb er genoeg...wachten is op de 15e mei.
    De grote lijn die ik zie is gewoon een approval.
    Als er al bezwaren waren waren die al lang veel eerder uitgesproken. Niets wijst op een afkeuring.

    Maar goed, met beleggen is niets zeker, daar ben ik nu wel achter gekomen.

  20. [verwijderd] 1 mei 2007 10:20

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Dendreon: Provenge's Shortcomings Have the Shorts Coming
    Tuesday May 1, 4:01 am ET

    Ishmiel Kapur submits: Perhaps one of the fastest stocks being shorted this past week and this coming week will be the one and only Dendreon Corporation (NasdaqGM: DNDN). That's right, this was the one that soared a few hundred percent a few weeks back as FDA advisors recommended the approval of their prostate cancer drug. You see how I emphasized 'recommended'? That's because the actual FDA regulators haven't actually given the final approval. And now there have been plenty of signs pointing to the possibility that they'll get a big red stamp on their application papers stating either rejected, turned-down, or even dismissed.
    ADVERTISEMENT


    Before I move on to the juicy indicators on a possible drop in share prices, understand that Dendreon Corporation is a biotechnology company that spends all its time trying to development and make a business out of therapeutics (a.k.a. chemicals) that boost up the human immune system's ability to fight evil cancers of all forms. Their biggest and potentially biggest cash-cow is their "Provenge (sipuleucel-T)", which is explained as "...an active cellular immunotherapy that has completed two Phase III trials for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer..." - in plain English, it means it's medicine for men's prostate cancer. It is expected to generate at least $1 billion in sales if formally approved, and on March 29, when the advisory panel to the FDA had recommended it for approval, their stock prices went up over $20 dollars, to later drop back to $15.

    More on the Advisory Panel: They're basically an aggregate of "experts", being scientists and doctors that give the thumbs up or down, and then the FDA comes out to make the decision formal. After so much publicity on DNDN's Provenge drug, experts have come out to reiterate what the news was all about. And life wouldn't be interesting without tons of criticism, and that's exactly what's been happening. While studies have shown that the drug prolongs the lives of patients with advanced prostatecancer, it doesn't show that it slows the spread of the disease (cancer cells still spreads to other major organs) - which is supposing the primary objective. The FDA comes out with their decision on May 15.

    Now the Indicators: Do you believe in inside information? Well you better start if you don't! One of the biggest indicators that I watch when looking at stocks is the holding and transaction activities carried out by the company's management. For DNDN, several big time management guys sold off their share holdings:

    The CEO, Mitchelle Gold, sold 202,090 shares of the company early in April - over 50% of his total holdings
    Two Directors, Ruth Kunath and Bogdan Dziurzynski, sold close to 100,000 throughout the month My question is, if these prominent company officials sold so many shares to capture in the gains, does that mean that they know something we don't? Maybe the possibility that the share prices might drop soon? You see, if it was just this stand-alone incident, maybe I wouldn't have been so boggled, but there were more. For example, how does this sound? Already made public is the fact that three of the 17 FDA panelists that were questioned came out to say that they're against recommending an approval. And then you also have other analysts like Jonathan Aschoff from Brean Murray Carret & Co. says that he expects the unsuccessful decision by the FDA. Others like Charles Duncan, an analyst at JMP Securities hints at the fact that he expects the FDA to ask for more support, trials and other need-bes.
    So we got some disapprovals from within the FDA, we've got some analyst doubts, what else? How about top oncologists advising the U.S. Food and Drug Administration to delay the approval of the drug. Maha Hussain and Howard Scher are a couple I can think of that are against it, both saying that the existing clinical trials for the drug just don't cut it for approval.

    Meanwhile, about 44% of the Company's shares are sold short. This number comes mid-April, and for all we know it could have gone up already - it definitely won't make any sense for the existing to cover their shorts as the price since that time has stayed relatively stagnant. This certainly implies that the market, if not several major fund houses, are bare on their expected chances of an approval.

    Finally, guess what DNDN's own researchers commented on the drug? "...the research data is less than perfect."

    You know what I think? I'm not a biotech or cancer expert, but I think the indicators speak for themselves. I'm going along with the short-sellers on betting that the FDA won't go along with the panel.

    biz.yahoo.com/seekingalpha/070501/340...
1.743 Posts
Pagina: «« 1 ... 51 52 53 54 55 ... 88 »» | Laatste |Omhoog ↑

Neem deel aan de discussie

Word nu gratis lid van Beleggen.nl

Al abonnee? Log in

Direct naar Forum

Zoek alfabetisch op forum

  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
Forum # Topics # Posts
Aalberts 466 7.019
AB InBev 2 5.506
Abionyx Pharma 2 29
Ablynx 43 13.356
ABN AMRO 1.582 51.701
ABO-Group 1 22
Acacia Pharma 9 24.692
Accell Group 151 4.132
Accentis 2 265
Accsys Technologies 23 10.714
ACCSYS TECHNOLOGIES PLC 218 11.686
Ackermans & van Haaren 1 189
ADMA Biologics 1 34
Adomos 1 126
AdUX 2 457
Adyen 14 17.752
Aedifica 3 916
Aegon 3.258 322.866
AFC Ajax 538 7.088
Affimed NV 2 6.297
ageas 5.844 109.893
Agfa-Gevaert 14 2.050
Ahold 3.538 74.339
Air France - KLM 1.025 35.047
AIRBUS 1 12
Airspray 511 1.258
Akka Technologies 1 18
AkzoNobel 467 13.042
Alfen 16 24.881
Allfunds Group 4 1.473
Almunda Professionals (vh Novisource) 651 4.251
Alpha Pro Tech 1 17
Alphabet Inc. 1 406
Altice 106 51.198
Alumexx ((Voorheen Phelix (voorheen Inverko)) 8.486 114.822
AM 228 684
Amarin Corporation 1 133
Amerikaanse aandelen 3.837 243.269
AMG 971 133.465
AMS 3 73
Amsterdam Commodities 305 6.691
AMT Holding 199 7.047
Anavex Life Sciences Corp 2 491
Antonov 22.632 153.605
Aperam 92 15.009
Apollo Alternative Assets 1 17
Apple 5 383
Arcadis 252 8.780
Arcelor Mittal 2.033 320.724
Archos 1 1
Arcona Property Fund 1 286
arGEN-X 17 10.305
Aroundtown SA 1 219
Arrowhead Research 5 9.745
Ascencio 1 28
ASIT biotech 2 697
ASMI 4.108 39.190
ASML 1.766 107.536
ASR Nederland 21 4.498
ATAI Life Sciences 1 7
Atenor Group 1 491
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 13.675
Axsome Therapeutics 1 177
Azelis Group 1 64
Azerion 7 3.392