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    Neurocrine Biosciences [NBIX] Gibt es einen Rebound ??? - 500 Beiträge pro Seite

    eröffnet am 16.05.06 19:57:58 von
    neuester Beitrag 20.02.07 22:27:25 von
    Beiträge: 15
    ID: 1.060.488
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    ISIN: US64125C1099 · WKN: 900964 · Symbol: UOT
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      Avatar
      schrieb am 16.05.06 19:57:58
      Beitrag Nr. 1 ()
      Biotech-Titel stürzt vorbörslich ab

      Aktien der Neurocrine Biosciences sind am Dienstag vorbörslich auf der Handelsplattform Instinet dramatisch abgerutscht, nachdem die die Arzneimittelbehörde FDA die Zulassung des Schlafmittels „Indiplon“ in der 15mg-Dosierung abgelehnt hat.

      Die FDA erklärte, im Moment sei Indiplon in dieser Dosierung nicht zulassungsfähig, allerdings habe man nicht alle eingereichten Informationen sichten können, so die FDA. Neurocrine erklärte, daß das Präparat in reduzierter Dosierung allerdings zugelassen worden sei. Neurocrine hat nach eigenen Angaben die Entscheidung der Behörde akzeptiert und wird weitere Schritte zur vollständigen Zulassung des Präparates mit der FDA abstimmen.

      Zuletzt notierte der Titel bei 31,02 Dollar (-43,2%).

      Quelle: © BörseGo - 16.05.2006

      Im Moment an der NADSAQ 21,73 $ minus 60,22 %

      Man sollte zwar nie in ein fallendes Messer greifen, aber hier kribbelt es. Was meint ihr ???
      Avatar
      schrieb am 16.05.06 21:10:14
      Beitrag Nr. 2 ()
      Aktuelle news zu Indiplon .
      Sollte Pfizer wirklich die Partnerschaft aufgeben würde das Neurocrine hart treffen also vorsicht.

      Neurocrine stock takes a big hit on FDA's Indiplon review
      Tuesday May 16, 2:51 pm ET
      By Aaron Smith, CNNMoney.com staff writer


      Neurocrine Biosciences' stock price plunged nearly 60 percent after the FDA gave mixed approval to Indiplon, a sleeping pill that the biotech developed with Pfizer, and analysts believe the partnership is at risk.

      The Food and Drug Administration approved 5 mg and 10 mg immediate release pills for Indiplon, but did not approve 15 mg extended release pills.

      Pfizer spokeswoman Betsy Raymond said her company was informed Monday night of the FDA decision by Neurocrine.

      Neurocrine released this statement from chief executive officer Gary Lyons: "While we are disappointed in the FDA action, we will move forward expeditiously to address the FDA's outstanding questions regarding the applications."

      Barbara Ryan, analyst for Deutsche Bank North America, said Pfizer will probably cut its partnership with Neurocrine, because the FDA's decision to not approve the larger-dose Indiplon - the dose that allows insomniacs to sleep through the night - has "no appeal whatsoever for Pfizer."

      "In light of today's developments, we expect that Pfizer will terminate its collaboration with Neurocrine for Indiplon," said Ryan in a published note.

      Al Rauch, analyst for A.G. Edwards & Sons, also said the Pfizer-Neurocrine partnership could be at risk.

      "We believe that if the XR tablet does not make it to the market, Pfizer's incentive to remain in the relationship with Neurocrine on Indiplon is greatly diminished; we are therefore removing Indiplon from our estimates," said Rauch, in an analyst note.

      Rauch said the impact on Pfizer was "negligible."

      Miller Tabak analyst Les Funtleyder said the FDA might have gotten scared over the fallout surrounding another sleeping pill: Ambien from the drugmaker Sanofi-Aventis. Researchers from the University of Minnesota Medical School and the Mayo Clinic recently found that Ambien causes some people to gorge on food while sleeping in the middle of the night. There have also been reports of sleep-driving and sleep-sex, with no memory of it afterwards.

      "It appears the FDA watches television news and did not like the idea of approving another drug that might make people run off the road," said Funtleyder, in a note published this morning.

      Pfizer, based in New York City, is the biggest drug maker in the world, with $51.3 billion in 2005 sales. San Diego-based Neurocrine reported $123 million in 2005 sales.

      To read more about the sleeping pill industry, click here.
      Avatar
      schrieb am 17.05.06 09:01:55
      Beitrag Nr. 3 ()
      The FDA Tries to Put Neurocrine to Sleep

      By Stephen D. Simpson, CFA
      May 16, 2006

      If you're a Neurocrine Biosciences (Nasdaq: NBIX) investor, this is a terrible day. If you're a DOV Pharmaceuticals (Nasdaq: DOVP) investor, you might feel stuck in a waking nightmare. If you're a Pfizer (NYSE: PFE) investor, you probably just shrug and move on to the next bit of news.

      Before Tuesday's open, Neurocrine announced that the Food and Drug Administration had issued approvable letters for the 5 mg and 10 mg versions of Indiplon, the company's promising insomnia drug, but not for the 15 mg extended-release version. This is not a case where the best two out of three wins -- there's some modest market opportunity for the lower doses, but it was the 15 mg dose that was to be the centerpiece to the story.

      That's bad news, of course, but it's not completely unheard of -- FDA rejections are an unfortunate part of the biotech/pharmaceutical process. What really fired me up, though, was the wording in the press release -- "the FDA indicated that they did not have an opportunity to review all of the information submitted during the NDA review cycles."

      What? Were the FDA folks in a rush to get home to watch American Idol? Were they too busy playing World of Warcraft? Of all the reasons, rationale, and excuses I've heard for rejecting a drug application, "we didn't have time to look at your data" has to score as the worst -- presuming that I'm interpreting this statement correctly. Seriously, even though I don't own any of these shares, this is the sort of thing that angries up the blood and makes me wonder whether the whole FDA should be scrapped and rebuilt.

      So, what now?

      Well, I don't see Pfizer really wanting to bother launching Indiplon without an extended-release formula. So maybe the best-case scenario is that I'm reading this statement correctly and the FDA simply couldn't review all of the clinical data by the decision's due date -- thereby raising the possibility that it could be approved later. Although that's not good news, since it gives competitors time to dig in, it's better than nothing for Neurocrine and DOV, which originally licensed the drug to Neurocrine after in-licensing it from Wyeth (NYSE: WYE) a while ago.

      Setbacks aren't always terminal -- as Elan (NYSE: ELN) and Biogen Idec (Nasdaq: BIIB) hope to soon experience -- though they are difficult. My gut instinct is to tell the investors in the biotechs to hang on, but I can't and won't pretend that this is going to be easy. I'm a longtime fan of Neurocrine, though, so my hope is that this all ends up working out for the company and its investors.
      Avatar
      schrieb am 17.05.06 16:42:55
      Beitrag Nr. 4 ()
      By Val Brickates Kennedy, MarketWatch
      Last Update: 10:24 AM ET May 17, 2006
      On Tuesday, the biotech group said the FDA issued an approvable letter for lower-dosage capsules of indiplon, meaning the agency believes the drug can be approved at a later date if certain conditions are met. However, the agency also determined a higher-dosage tablet form of the drug was not approvable.
      Neurocrine shares lost over 60% of their value on Tuesday. On Wednesday, Lehman Brothers cut its rating of the stock to equal weight while Morgan Stanley lowered its price target to $16 a share.
      Avatar
      schrieb am 17.05.06 17:20:58
      Beitrag Nr. 5 ()
      "not approvable"... "approvable"... das ist doch lächerlich. DSCO hat schon zwei "approvable" für Surfaxin erhalten und es ist völlig offen, ob Surfaxin jemals auf den Markt kommen wird. ENCY hat "approvable" erhalten mit Zulassung auf unbestimmte Zeit verschoben und ist um 50% abgestürzt wie NBIX. Ich sehe effektiv keinen Unterschied zwischen "approvable" und "not approvable", denn auch ein "not approvable" ist nicht definitiv, ebenso wie ein "approvable" noch lange nicht heißt, das jemals eine Zulassung erfolgt... denn offensichtlich scheinen manche Konditionen der FDA nicht erfüllbar zu sein und ein ewiges "approvable" hilft keinem.

      Wie dem auch sei... ich habe NBIX long gekauft... die weitere Entwicklung hängt wohl von Pfizer ab - werfen die ihre Big-Pharma Macht in den Ring oder ziehen sie sich jetzt zurück und lassen NBIX im Regen stehen? Nur eins ist im Moment klar... und zwar das alles unklar ist. Die ganzen Analysten drehen ihr Fähnchen schneller im Wind, als man danach irgendwie handeln könnte und natürlich grundsätzlich postum... und wenn NBIX dann auf einmal doch nur scheintot ist switchen sie wieder auf buy. Dies Analysten wissen in der Regel auch nicht mehr und dementsprechend wird nur das bereits bekannte durchgekaut... mal sehen...

      mfg ipollit

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      Avatar
      schrieb am 17.05.06 21:57:36
      Beitrag Nr. 6 ()
      FDA Sends NBIX Reeling



      Back on April 26, when Neurocrine Biosciences (Nasdaq:NBIX) was made the Bear of the Day selection, I said that investors should beware a "sell the news" scenario with respect to FDA approval of NBIX's lead candidate Indiplon. But I did not expect a "not approved" judgment on the 15-milligram Indiplon tablet; mostly, I thought the valuation at roughly $62 per share was still too high, given the competitive landscape of the potential Indiplon market - Ambien from Sanofi-Aventis (NYSE:SNY) and Lunesta from Sepracor (Nasdaq:SEPR) - was likely going to result in more of a zero-sum game than NBIX and its partner Pfizer (NYSE:PFE) were thinking at the time.

      The FDA gave an "approvable" rating - meaning, essentially, that maybe it's OK, but we may need more data - for the 5 and 10-milligram immediate-release Indiplon capsule. But it was the 15-milligram tablet that was going to have the sleep maintenance indication, which was going to compete directly with Lunesta and the new Ambien CR. The "not approved" for this indication is an enormous negative for Neurocrine, as I had modeled that 90% of Indiplon sales were to be for this 15-milligram tablet. And Indiplon itself was representing 90% of NBIX's value at around $60 per share. As of this posting, shares of NBIX are trading at $23.

      What we're waiting for is the FDA reasoning for its judgment. All the department has said so far is that there was an insufficient ability to approve the Indiplon tablet. Whether that means there was insufficient data or the FDA simply has not had enough time to review all of it makes all the difference. I won't upgrade shares of NBIX until I find out for certain whether this drug is dead. If it's merely a matter of paperwork, the drug could be back in as few as three months. If it's got to go back to the clinic, they're likely looking at 18 months to two years.
      Avatar
      schrieb am 15.08.06 18:12:53
      Beitrag Nr. 7 ()
      Antwort auf Beitrag Nr.: 21.611.004 von MorkMan am 16.05.06 19:57:58so, ich meine, dass man sich mit einer kleinen Position heranwagen könnte. Allerdings sollte man noch Pulver trocken halten.
      Andererseits, was soll denn noch an schlechten Nachrichten kommen?
      Cash ist ja auch erstmal vorhanden und macht einen nicht geringen Teil der MK aus...
      Avatar
      schrieb am 16.08.06 11:04:09
      Beitrag Nr. 8 ()
      Antwort auf Beitrag Nr.: 23.458.168 von mr.lukoil am 15.08.06 18:12:53Genau deswegen bin ich bereits drin.
      Das kann nach einer positiven Entscheidung im August ganz schnell wieder nach oben gehen...

      Gruss Loseit :cool:
      Avatar
      schrieb am 17.08.06 21:18:43
      Beitrag Nr. 9 ()
      Sensationeller Kursanstieg. Weiß jemand wieso?
      Übernahme?
      Dass man die Probleme mit dem Schlafmittel so schnell in den Griff bekommen hat, ist wohl unwahrscheinlich.
      Avatar
      schrieb am 18.08.06 09:47:19
      Beitrag Nr. 10 ()
      Antwort auf Beitrag Nr.: 23.488.288 von harahikari am 17.08.06 21:18:43Dazu aus dem yahoo-Board:


      Only two possible reasons exist for this price volume explosion. Either way longs are in for their turn.

      Reason 1:
      The FDA meeting is this month. There are only 10 business days remaining in August. This could be short covering in fear of a positive PR upon the FDA meeting. NBIX has 37.8 million shares outstanding with 3.9 million shares short last time I checked ( been awhile since I checked short list,but the numbers should be pretty close and the point remains the same I am making). That equals 15.67% of shares shorted that may want to cover. We traded 4.2 million shares today. Average volume the last ten days I am guessing was about 400,000. That means a large percentage of shorts could have theoretically covered in todays trading volume. Therefore the price volume increase today could be the result of short covering. Question is why did so many decide to cover today so close to the end of August and the FDA meeting? Seems like more shorts would have covered earlier in the month to reduce their risk of getting caught in a squeeeze. Read on for next possible reason.

      Reason 2.
      Someone knows a positive news release is imminent. Info is out that the FDA meeting is to be positive. This would cause buying which in turn would increase price which in turn gets the shorts to start covering further driving the price up. That is what I did this morning, covered my short because of price volume action.

      So there you all have it. One of these is the correct answer as I believe they are the only two possibilities. That's my take on todays movement. Anyone else have a different explanation? I would love to hear your input. Thanks for reading this long oration and I hope it proves helpful.

      Seems like most of the posts on this board are just a bunch of slams with no thought to adding investment value. I am in stocks to make money, whether I make it shorting or going long doesn't matter and it should not to you either. I have been on both sides of the fence as to NBIX and will switch in a second if I can make money taking the opposite position. Good Luck to All.
      Avatar
      schrieb am 18.08.06 11:17:34
      Beitrag Nr. 11 ()
      Antwort auf Beitrag Nr.: 23.491.775 von loseit am 18.08.06 09:47:19naja. könnte doch auch einfach sein, dass nbix zu billig ist.
      der einbruch war heftig und eine Stabilisierung des Kurses ist eingetreten. Eine Gegenreaktion auf den einbruch gab es bislang nicht.

      Mich freut, dass der Anstieg nun so kurz nach meinem Kauf erfolgt ist, die gründe warum jemand anders gerade jetzt kauft, interessieren mich dabei eher nicht. Die entscheidende Frage ist ja eher, wird es eine nachhaltige Erholung geben.

      Mittel- bis langfristig wird sich wohl ein Investor finden, der sich an nbix beteiligen wird, sei es nun ein Pharmaunternehmen oder ein finanzinvestor. Darauf hoffe ich zumindest.
      Avatar
      schrieb am 21.08.06 15:37:59
      Beitrag Nr. 12 ()
      Antwort auf Beitrag Nr.: 23.493.216 von mr.lukoil am 18.08.06 11:17:34bin heute mit eröffnung long gegangen.....NBIX ist mir bei meiner wochenend recherche aufgefallen; auch wenn das candle am FR nicht verheißungsvoll war.....den starke move am do hat mich überzeugt.
      potential kurzfristig bis gap-close

      der kornspitz
      Avatar
      schrieb am 21.09.06 10:38:43
      Beitrag Nr. 13 ()
      Antwort auf Beitrag Nr.: 23.546.066 von Kornspitz am 21.08.06 15:37:59Jetzt sollte bald zum Jahresende evt. eine Übernahme kommen, ich sehe hierfür eine hohe Wahrscheinlichkeit, wenn die Zulassungsdaten wieder mehr im Mittelpunkt stehen werden. Ob noch eine lange PhaseIII Studie selber finanziert werden muss, wird dann eher nebensächlich.
      Avatar
      schrieb am 23.01.07 12:25:08
      Beitrag Nr. 14 ()
      Antwort auf Beitrag Nr.: 24.078.297 von flow_solver am 21.09.06 10:38:43Jetzt kommt langsam ein Run, der sicher noch bis 25$ in diesem Jahr gehen könnte.
      Avatar
      schrieb am 20.02.07 22:27:25
      Beitrag Nr. 15 ()
      Antwort auf Beitrag Nr.: 27.127.197 von flow_solver am 23.01.07 12:25:08Neurocrine Biosciences Announces the Resignation of Adrian Adams From the Board of Directors

      SAN DIEGO, Feb. 20 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, (Nachrichten) Inc. announced today that Adrian Adams has resigned from the Company's Board of Directors.

      "We are grateful to Adrian for the extensive experience that he has brought to Neurocrine over the past two years," said Joseph A. Mollica, Ph.D, Chairman of the Board, Neurocrine Biosciences.

      "We want to thank Adrian for his hard work and dedication and for being such a valuable resource for Neurocrine," said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences.

      Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, irritable bowel syndrome, endometriosis and CNS related disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com/.

      In addition to historical facts, this press release may contain forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general. Other risks are described in the Company's report on Form 10-K for the year ended December 31, 2006. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.


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      Neurocrine Biosciences [NBIX] Gibt es einen Rebound ???