ARNA - Arena Pharmaceuticals

Intraday hat der 15min bei $1.56 ein Kaufsignal geliefert.
Einsteigen und liegen lassen bis wir bei $2+ sind.
 

http://www.petitiononline.com/passlorc/petition.html  

 

 

Schlusskurs $1.71!
Shorts haben heute angefangen Ihre Bestände zu covern , welche den Kurs weiter nach oben treiben werden.
$2+ ist nur eine Frage der Zeit in dieser Woche !
Doppebottom bei $1.51 - würde einen Stopp Loss bei $1.50 setzen und stückchenweise mit steigenden Kursen nach oben ziehen.
Auf geht´s !!  

 

ich setze auf den Complete Response Letter  

Pre-Market
Time (ET) Pre-Market
Price Pre-Market
Share Volume
08:27 $ 1.73 800
08:25 $ 1.73 132
08:24 $ 1.73 300
08:23 $ 1.73 1,000
08:23 $ 1.73 300
08:23 $ 1.73 933
08:23 $ 1.73 300
08:23 $ 1.73 167
08:22 $ 1.74 200


Read more: http://www.nasdaq.com/aspxcontent/...NA&mkttype=pre#ixzz11UFPlFKw  

Investors Smell a Rat
Last month, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals (ARNA) outweigh the benefits. That move came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA briefing documents and caught some people, including Wall Street analysts, by surprise.

The decision caused a stir among investors and a subsequent controversy about whether Arena properly and promptly disclosed the existence of the tumor data (look here). In comments made to Wall Street analysts following the FDA panel vote, CEO Jack Lief insisted the info was handled correctly. An FDA decision is expected later this month.

Now, a petition has begun circulating the Internet ,in which the FDA is being asked to override the panel vote and approve the diet pill. The basic case is that the FDA staff made some fundamental mistakes in their analysis. In the FDA briefing documents, the petition contends, an FDA reviewer made “a highly damaging, but incorrect, statement” that “an excess number of malignant tumors developed in female rats with (Lorqess) at doses within seven-fold of the proposed clinical dose of 10mg BID.” In other words, the FDA analysis overstated the case and confused some of the panelists, who were not experts in such matters.

For instance, the petition argues that of the nine panelists who voted ‘no,’ only two did not cite tumors in rats as their main concern. “This suggests seven panelists that voted no might have voted yes if the FDA had provided a toxicology or a carcinogenic expert as support for any concerns the panelists might have had regarding the relevance to human subjects.It is clear that these panelists were confused or uncertain what the rat data showed, and therefore voted no, not based on scientific evidence but rather the fear of uncertainty.

And then there’s this closing appeal to FDA officials:

“We believe that the long term effects of this event could result in irreparable damage to the biotechnology and pharmaceutical industry as a whole. The dramatic elevation of concern over rat cancer…has prompted class action lawuits against Arena Pharmaceuticals. Clearly these data were adjusted to show significance in cancer occurrence where none existed. If all pharmaceutical and research firms were to release all toxicological results from their pre-clinical or animal studies to the investing community, equity markets in that industry might cease to exist…”

“The pendulum has swung too far at the FDA if they influence Advisory Committees to vote no for a drug that poses very little risk to the public at large, and certainly less than currently available therapies, and where there is a demonstrable clinical benefit in terms of additional weight loss and reduction in cardiovascular risk factors. This is particularly true if the methodology underlying that influence is unscientific and based upon assumptions that are contrary to accepted scientific knowledge.”

The people who initiated the petition do not reveal their identity and instead preferred to be called ‘Concerned Citizen,’ and they argue that by approving the Lorqess pill, the agency would promote public health, saving untold dollars from the nation’s health costs. Beyond such concerns, however, it is unclear whether the petitioners are tied to Arena or are simply investors who were angered by the FDA review.

In any event, their belief that releasing all toxicology data from pre-clinical or animal studies may fatally damage equity markets may be construed as rather sweeping, if not dramatic. Proper disclosure - and proper analysis - remain desirable. The real issue, of course, was whether the rat data was not only disclosed as it should have been, but scrutinized correctly by the FDA staff.

Diet pills, though, are a whole other animal, you’ll pardon the pun. For more than a decade, as you may recall, various diet drugs have been linked to safety issues, most notably the fen-phen weight-loss cocktail, half of which was withdrawn in 1997 over serious links to heart and lung conditions. Given the current environment in which safety is a prime concern, one should not be surprised if the FDA errs on the side of caution. Whether the equity markets then collapse also remains to be seen.

http://seekingalpha.com/article/...investors-smell-a-rat?source=yahoo  

Aktueller Kurs $1.81!  

 

Arena and Eisai Announce Upcoming Lorcaserin Presentations at Obesity 2010

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today upcoming lorcaserin presentations at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society, in San Diego, California.Lorcaserin, which Arena discovered and developed, is intended for weight management, including weight loss and maintenance of weight loss , in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.

"Obesity 2010 is an excellent scientific forum to present results from our recently completed clinical study evaluating the effects of lorcaserin on appetite, energy intake and energy expenditure," stated William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We look forward to presenting at this event, and to lorcaserin's October 22nd PDUFA date."

The meeting schedule includes presentations of a lorcaserin mechanism of action study conducted by Drs. Eric Ravussin, Leanne Redman, Corby Martin and Steven Smith at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.

Saturday, October 9, 2010

* Oral Abstract Presentation: Lorcaserin, a Novel 5-HT2C Receptor Agonist, Causes Weight Loss Without Stimulating Energy Expenditure
* Session Time: 4:45 p.m. - 6:15 p.m. Pacific Time (PT)

Sunday, October 10, 2010

* Poster Presentation: Lorcaserin, a Selective 5-HT2C Receptor Agonist, Reduces Energy Intake and Appetite
* Session Time: The poster will be on display from 9:30 a.m. to 1:45 p.m. PT and from 3:15 p.m. to 6:30 p.m. PT. Presenters will be available to discuss the poster from 12:30 p.m. to 1:30 p.m. PT.

About Lorcaserin

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for review of the application. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, therapeutic indication and use, safety, efficacy, tolerability, mechanism of action and regulatory review and approval of lorcaserin; how lorcaserin is believed to act; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the risk that regulatory authorities may not find data from Arena's clinical trials and other studies sufficient for regulatory approval; the timing of any regulatory review and approval is uncertain; Arena's ability to obtain and defend its patents; risks related to commercializing new products; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner Arena or others expect or at all; Arena's ability to obtain adequate funds; the timing and receipt of payments and fees, if any, from Eisai and Arena's collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contacts: Arena Pharmaceuticals, Inc.



Investor Inquiries:


Media Inquiries: Russo Partners


Cindy McGee


David Schull


cmcgee@arenapharm.com


david.schull@russopartnersllc.com


858.453.7200, ext. 1479


858.717.2310



Contacts: Eisai Inc.



Investor Inquiries:


Media Inquiries:


Dave Melin


Lynn Kenney


david_melin@eisai.com


lynn_kenney@eisai.com


908.255.6378


201.746.2294  

http://www.signonsandiego.com/news/2010/oct/09/...t-back-against-fda/  

bin heute pre market noch rein, denke vor dem hearing wird sie noch etwas hoch getradet.  

fast ne million getradet in der ersten stunde... und das HEUTE am columbus day! das wird ne gute woche. viel spass allen  

Könnte ne Überraschung geben...

Die Sache mit dem Krebs bei den Ratten wird überbewertet...

Nach unten sollte vieles schon eingepreist sein...

Gruss
-cubiak  

denke ich auch "nach unten vieles eingepriesen".... es geht theoretisch schon noch weiter nach unten - aber ich habe eher die erfahrung gemacht, dass vor verhandlungen schnell noch mal nach oben getradet wird und dann am verhandlungstag großer ausverkauf ist. daher vorerst nur ein kurzer zock geplant.

nachdem ich mich mittlerweile mehr eingelesen habe, könnte daraus aber auch mehr werden - vielleicht gibts ja wirklich eine überraschung. klar ist: WENN es diese gibt wird es heftige ausschläge nach oben geben.  

weiß nicht ob es am feiertag liegt oder am wert... aber in amerika haben heute wohl schon mehrere probleme gehabt, den wert zu ordern. dann schnallen wir uns mal an für morgen ;-)  

... lief ganz gut heute, mal sehen wie dienstag und mittwoch verlaufen.
aktueller kurs bei 1,76 $ .... ich tippe auf ähnlichen oder besseren verlauf bis zur verhandlung, daher 1.90$ bis donnerstag -> bis zu 10% in zwei tagen meine prognose.

viel glück bis zur entscheidung!  

Werft auch mal einen Blick in den CIIC Thread. CIIC ist völlig unterbewertet.Das Volumen war gestern das erste Mal seit Langem über dem 3Monats Volumen...  

die 10% die ich gestern erwartet hatte haben wir nun mit gestern und heute bereits ugetoppt - und das war heute noch nicht das tageshoch glaube ich... außerdem bleiben noch zwei weitere tage.  

Posted on 10/11/2010 by Leo Goldman

NEW YORK (Market Intellisearch) -- ARNA options saw interesting call activity today. A total of 550 put and 2,198 call contracts were traded raising a low Put/Call volume alert. Today's traded Put/Call ratio is 0.25. There were 4.00 calls traded for each put contract.

Summary of all Unusual Trading Activities

A significant increase in the trading volume of a stock's option often is a precursor of movement by the underlying stock. In such instances, Put/Call Ratio can be used as an investor sentiment indicator, where a high ratio implies that the overall investor sentiment is bearish and a low Put/Call ratio implies that the overall sentiment is bullish.

Arena Pharmaceuticals (ARNA) closed at $1.67 in the last trading session and opened today at $1.70. ARNA is trading at $1.76, up $0.09 (+5.39%) in today's trading session. The daily low is $1.68 and the high is $1.78. The trading volume of 4,925,267 is below the average volume of 14,041,600 shares. ARNA is trading below the 50 day moving average and lower than the 200 day moving average. The technical momentum Relative Strengh Index indicator shows oversold conditions. The stock's 52 week low is $1.51 and 52 week high is $8.00.  

habe hier mal ein paar meinungen aus usa eingeholt und die tendieren eher zu "alles negative eingepriesen - am donnerstag wird nichts schlimmes passieren"... gut, sogar noch besser als meine variante. *g*  

chart is bullish and 22. of oktober comes near...  

.....würde den chart ebenso als eher bullish deuten. meinungen?