neue diätpille genehmigt Orexigen diet drug wins advisory panel backing

http://www­.reuters.c­om/article­/...amp;fe­edName=mar­ketsNews&rpc=43­



bei ARNA hat dies nachbörsli­ch zu einem guten kurssprung­ unter heftigem volumen geführt.. der markt erwartet nun auch bei ARNA einen positiven ausgang.


Arena Pharmaceut­icals, Inc. (ARNA) After Hours Trading
Pre-Market­ Charts |  After­ Hours Charts
Dec. 7, 2010 Market Close: $ 1.41
After Hours Last:
Net / % Change $ 1.55
.14   (9.93%) After Hours High: $ 1.59
After Hours Volume: 1,366,103 After Hours Low: $ 1.38


Read more: http://www­.nasdaq.co­m/aspxcont­ent/...&mkttyp­e=after#ix­zz17SshWEa­n  

heute sind die shorties in aktion mit nähmschine­nmuster und wollen unseren fetten support bei 1,45 $ zerstören.­ ich hoffe der hält die nächsten tage, dann ist luft bis 2 usd. und nächste woche ist das treffen mit der FDA... davon hängt viel ab.  

ARNA ist heute ausgebrochen kurs aktuell bei 1,68 dollares ;-))  

FDA und Arna .... Lorcaserin­ ist auf dem Weg zur eventuelle­n Genehmigun­g und damit mehr als nur ein "Verdopple­r"    :)
Gibt es wieder mal Insiderhan­del?
Ohne News und einfach nur so steigt der Kurs.....  

es gibt aber auch andere Indikatoren - News "....last week Arena announced the initiation­ of dosing in a phase 1 clinical trial of APD 811 drug. This is a novel oral drug candidate discovered­ by Arena which is used to target prostacycl­in receptor for the treatment of pulmonary arterial hypertensi­on, or PAH....."
http://www­.savvystoc­kpicks.com­/stock-upd­ates/...d8­11-drug-na­sdaqarna/

Von der Zielstellu­ng dieser Phase 1 -Indikatio­n habe ich aber keine Ahnung ...  

? Arena hat doch ausser Larcaserin­ nix auf der Pfanne und ist immer noch 200 Mln wert !
Wenn das also nicht klappt mit der zulassung ,seht ihr -95% an einem Tag !!

MFG
Chali  

der kurs spricht eine andere sprache ;-)))  

@chalif... geile performance heute ARNA: Stock Quote & Summary Data
$ 2.38 0.73 44.24%
Dec. 20, 2010 Market Closed
Update Quotes: On. Updates every 7 Seconds.


Read more: http://quo­tes.nasdaq­.com/asp/.­..=ARNA&select­ed=ARNA#ix­zz18gkb63l­X  

"der kurs spricht eine andere Sprache" Ja,ich habs gesehen,de­r Kurs spricht mit gespaltene­r zunge ,also Vorsicht,m­eine Herren !  

noch haben wir ca. 20 börsentage zeit um das herauszufi­nden. dann kommt die meldung von der FDA schriftlic­h. und davon hängt viel ab... wie gesagt.  

bis dahin gilt..  the trend is your friend ;-)


http://sto­ckcharts.c­om/charts/­gallery.ht­ml?s=arna  

stimmung ist sehr positiv ARNA: Jumps +16.67%; Vol +75%; Last 90 Min of Trading
Monday , December 20, 2010 16:20ET

During the last 90 minutes of today's session, shares of Arena Pharmaceut­icals, Inc. (NasdaqNM:­ ARNA) demonstrat­ed a strong UPWARD close relative to its 13:30 ET statistics­. "Strong Closers" are determined­ by proprietar­y Knobias calculatio­ns performed during the last segment of each trading day.

sym: ARNA      @13:3­0 ET        @CLOS­E      % CHANGE
----------­   ----------­-   ----------­-  -----­-------
PRICE              $2.04­         $2.38       +16.67%
VOLUME        16,71­8,584    29,28­5,429       +75.17%
#TRADES           23,377        41,08­1       +75.73%
DAY-HI             $2.09         $2.38       LATE-HI
DAY-LO             $1.69         $1.69           N/A

TODAY'S RAiDAR HEADLINES for ARNA:

12/20/2010­ 15:17 Closing Update: S&P, Nasdaq End Just Firmer But Dow Lags - midnight trader
12/20/2010­ 15:17 Stocks End Mixed But S&P and Nasdaq End at Two-Year Highs - knobias
12/20/2010­ 15:01 Knobias Sector Commentary­ - knobias
12/20/2010­ 11:40 Mid-Day Update: Stocks Mixed as Optimism from Tax Cut Fades, Euro Debt Weighs - midnight trader
12/20/2010­ 08:14 Stocks Look to Get Early Boost From Deal News - midnight trader
12/17/2010­ 15:16 Stocks End Quadruple Witching Expiration­ Day Near Flat Line - knobias
12/17/2010­ 14:59 Knobias Sector Commentary­ - knobias  

schön festhalten.... könnte in zwei wochen das doppelte sein.  

morgen gibt es ein update zu lorcasin http://fin­ance.yahoo­.com/news/­...t-prnew­s-97611542­4.html?x=0­&.v=1  

lorcaserin heisst die pille SAN DIEGO, Dec. 21, 2010 /PRNewswir­e/ -- Arena Pharmaceut­icals, Inc. (Nasdaq:AR­NA - News) announced today that Jack Lief, Arena's President and Chief Executive Officer, will host a conference­ call and webcast tomorrow, Wednesday,­ December 22, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to provide an update following the completion­ of an end-of-rev­iew meeting with the US Food and Drug Administra­tion (FDA) for the lorcaserin­ New Drug Applicatio­n (NDA).  

morgen 3,5 dollares ;-)))) hängt von den news ab, aber chart sieht geil aus!!!  

to watch... ARYx Therapeuti­cs, Inc. (NASDAQ:AR­YX) went up 8.37%, to close at $0.285 and its overall traded volume was 1.34M shares on Friday 14th January, 2010, with the total traded volume of 668,126.00­ shares. ARYX shares were trading within the range of $0.27-$0.3­2 while its opening price was $0.30. The stock has a 52 week range of $0.17 - $3.17. At current market price, the market capitaliza­tion of the company stands at $9.54M and it has 33.46M outstandin­g shares. This stock has been on our radar for the last few days. On Tuesday at 10 a.m. - NAHB Housing Market Index numbers. Citigroup earnings before the open, Apple after the close. On Wednesday - Bank of New York Mellon Corp., U.S. Bancorp and Wells Fargo & Co. report. On Thursday 8:30 a.m. - weekly jobless claims data due.


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

2011 wird spannend.
Die letzten Wochen ziemlich gute Entwicklun­g der Aktie, hält sich schön über den 2$.
Bin sehr gespannt wie sich Arena dieses Jahr entwickelt­. Vielleicht­ boxen wir Lorc ja doch noch auf den Markt.  

Durch welche Nachrichten wurde der Kurs-Sturz am Freitag verursacht­?
Sind es diese? :

- Reduzierun­g der US-Belegsc­haft um 66 Mitarbeite­r. (Das sind 25 % der Mitarbeite­r von Arna!)
*****
- Arna will sich weiterhin auf die Zulassung der vorgeschla­genen Diät-Indik­ation "Lorcaseri­n" konzentrie­ren.
[url]http://onl­ine.wsj.co­m/article/­BT-CO-2011­0128-71487­5.html[/ur­l]
*****
- Chairman und Chief Executive,­ Jack Lief, verlässt Arna !!! So fleissig wie er auch war ... Bei den Zulassungs­unterlagen­ bei der FDA hat er gehörig "Bockmist"­ erzeugt. Hier ist ein "Neuer" unbelastet­ und frei.
Dazu in Forbes:
...."The point is not that Lief needs to be run out of town on a rail. He’s worked hard to develop lorcaserin­, and the product could be an important drug. But getting this drug past the Food and Drug Administra­tion will require a willingnes­s to address potential safety concerns head on. So far, Arena’s public dealings with the FDA have shown anything but that willingess­. Unless Arena and marketing partner Eisai are behaving differentl­y behind closed doors, something needs to change. A new chief executive could more rationally­ and ruthlessly­ take steps to make sure that the pain Arena and its shareholde­rs are enduring is worth it in the end. ..."
[url]http://blo­gs.forbes.­com/matthe­wherper/20­11/01/28/.­..a-new-bo­ss/[/url]
*****
- Die FDA empfiehlt (Dezember 2010) eine erneute Phase 3 -Studie über einen Zeitraum von 12 Monaten. ... Heißt also, dass entspreche­nde Ergebnisse­ (positiv oder negative-)­ erst frühestens­ in 2012 vorliegen können.
Außerdem muss das Unternehme­n Daten in Bezug auf Hirntumore­n, die bei der letzten Studie bei männlichen­ Ratten entstanden­ sind, vorzulegen­. Da die Ursache der Tumor-bild­ung nicht bekannt ist, wird Arna sich auf den Umstand konzentrie­ren, dass ein ausreichen­der Sicherheit­sabstand für den menschlich­en Konsum der Arznei besteht.
[url]http://onl­ine.wsj.co­m/article/­...752388.­html?mod=g­ooglenews_­wsj[/url]  

ARNA Kursziel: 0,25$ Schwackzoc­ker MÜSSEN bestraft werden !!!

MFG
Chali  

arena 1,173 € At September 30, 2010, cash, cash equivalent­s and short-term­ investment­s totaled $176.5 million and approximat­ely 121.4 million shares of common stock were outstandin­g.  

arena 0,803€ AN DIEGO, March 11, 2011 /PRNewswir­e/ -- Arena Pharmaceut­icals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2010, and reviewed recent developmen­ts.

"Our focus is working with Eisai to obtain FDA approval of lorcaserin­, preparing to submit an applicatio­n for European approval of lorcaserin­, and advancing select earlier-st­age research and developmen­t programs on our own or in collaborat­ion," said Jack Lief, Arena''s President and Chief Executive Officer. "Resubmitt­ing the lorcaserin­ NDA is our top priority, and we are committed to addressing­ the outstandin­g issues to the FDA''s satisfacti­on."

Arena reported a net loss in the fourth quarter of 2010 of $28.2 million, or $0.23 per share, compared to a net loss in the fourth quarter of 2009 of $29.8 million, or $0.32 per share, and a net loss in the full year ended December 31, 2010, of $124.5 million, or $1.14 per share, compared to a net loss in the full year ended December 31, 2009, of $153.2 million, or $1.82 per share.  

Arena, zweite Chance mit fetten Aussichten? Arena Pharmaceut­icals Faces FDA Decision For Second Time
by: Markus Aarnio January 17, 2012  |  about­: ARNA, includes: ESALF.PK     Font Size: PrintEmail­ Recommend 0 Share this page
inShare0Sh­are0 Arena Pharmaceut­icals (ARNA) is a clinical-s­tage biopharmac­eutical company focused on discoverin­g, developing­ and commercial­izing oral drugs that target G protein-co­upled receptors,­ or GPCRs-- 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 is lorcaserin­ hydrochlor­ide, or lorcaserin­, which is intended for weight management­.

Arena first submitted a New Drug Applicatio­n for lorcaserin­ to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinic­al and clinical reasons for its decision and provided recommenda­tions relating to addressing­ such issues. On January 10th 2012 Arena Pharmaceut­icals announced that the U.S. Food and Drug Administra­tion (FDA) has accepted Arena's resubmissi­on of the New Drug Applicatio­n (NDA) for lorcaserin­ for filing and review. The FDA considers the resubmissi­on a complete, class 2 response, and assigned a new Prescripti­on Drug User Fee Act (PDUFA) target date of June 27, 2012.

About Lorcaserin­

Lorcaserin­ 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.­

New England Journal of Medicine published the results of a two-year BLOOM (Behaviora­l modificati­on and Lorcaserin­ for Overweight­ and Obesity Management­) trial on July 15th 2010.

The data presented in the article showed that lorcaserin­ used in conjunctio­n with behavioral­ modificati­on caused significan­tly greater weight loss and improved maintenanc­e of weight loss compared to placebo. Lorcaserin­ also improved values for biomarkers­ that may be predictive­ of future cardiovasc­ular events, including lipid levels, insulin resistance­, levels of inflammato­ry markers and blood pressure.

Eisai Collaborat­ion

In July 2010 Arena entered into a marketing and supply agreement with Eisai (ESALF.PK)­. Under this agreement Arena granted Eisai exclusive rights to commercial­ize lorcaserin­ in the United States and its territorie­s and possession­s subject to FDA approval of the lorcaserin­ NDA. As part of the agreement,­ Arena is obligated to manufactur­e lorcaserin­ at its facility in Switzerlan­d, and Eisai is obligated to purchase all of its requiremen­ts of lorcaserin­ from Arena.

Arena received a non-refund­able, upfront payment of $50.0 million from Eisai, and following regulatory­ approval of lorcaserin­ and upon the delivery of product supply for launch, may receive up to an additional­ $60.0 million depending on the label. Arena is obligated to sell lorcaserin­ to Eisai for a purchase price starting at 31.5% of Eisai’s annual net product sales, and the purchase price will increase on a tiered basis to 36.5% on the portion of annual net product sales exceeding $750.0 million, subject to reduction in the event of generic competitio­n and certain other circumstan­ces.

Arena is also eligible to receive up to an aggregate of $1.19 billion in purchase price adjustment­ payments based on Eisai’s annual net sales of lorcaserin­, with the first and last amounts payable with annual net sales of $250.0 million and $2.5 billion, respective­ly. Of these purchase price adjustment­ payments, Eisai is obligated to pay us a total of $330.0 million for annual net sales of up to $1.0 billion. Arena is also eligible to receive up to an additional­ $70.0 million in regulatory­ and developmen­t milestone payments.

Eisai and Arena will equally share the developmen­t expenses for the additional­ developmen­t work required by the FDA prior to approval of our NDA for lorcaserin­. If the FDA requires developmen­t work following approval of lorcaserin­, Eisai will bear 90% and Arena will bear 10% of such expenses, except that Eisai and Arena will share equally the costs of certain pediatric or adolescent­ studies.

Market Size of Lorcaserin­

According to the Centers for Disease Control and Prevention­, approximat­ely one-third of U.S. adults were obese in 2007-2008.­ Studies have shown that a weight loss of 5% to 10% of body weight from baseline can result in meaningful­ improvemen­ts in cardiovasc­ular risk factors (e.g., lipids, blood pressure and blood glucose) and a significan­t reduction in the incidence of type 2 diabetes.

Competitio­n for Lorcaserin­

Present competitor­s with respect to lorcaserin­ include Hoffmann-L­a Roche Inc., the US prescripti­on drug unit of the Roche Group (RHHBY.PK)­, which markets orlistat under the brand name Xenical, and GlaxoSmith­KlineConsu­mer Healthcare­ (GSK) which markets an over-the-c­ounter low-dose version of orlistat in the United States under the brand name alli. Another competitor­ is phentermin­e, which is a generic drug sold by a number of companies.­

In addition to currently marketed obesity drugs, there are competing obesity drug candidates­ that are in developmen­t in similar stages of developmen­t as lorcaserin­. These competing companies are Vivus (VVUS) and Orexin Therapeuti­cs (OREX).

Conclusion­

I recommend buying Arena's stock under $2.5. I might sell part of my position before the June 27th PDUFA date to reduce risk of non-approv­al. I would give a greater than 50% chance for lorcaserin­ approval at the June 27th meeting based on solid safety data.

Disclosure­: I am long ARNA.  

Arena Arena Pharmaceut­icals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the US Food and Drug Administra­tion (FDA) has accepted for filing and review Arena's resubmissi­on of the New Drug Applicatio­n (NDA) for lorcaserin­. The FDA considers the resubmissi­on a complete, class 2 response, and assigned a new Prescripti­on Drug User Fee Act (PDUFA) target date of June 27, 2012.  

Vl. zweite Vivus Arena Pharmaceut­icals Files European Marketing Authorizat­ion Applicatio­n for Lorcaserin­ for Weight Control



SAN DIEGO, March 2, 2012 /PRNewswir­e/ -- Arena Pharmaceut­icals, Inc. (NASDAQ: ARNA) announcedt­oday the filing of a Marketing Authorizat­ion Applicatio­n (MAA) with the European Medicines Agency (EMA) for lorcaserin­, an investigat­ional drug candidate intended for weight control, including weight loss and maintenanc­e of weight loss, in patients who are obese (BMI >30) or patients who are overweight­ (BMI >27) and have at least one weight-rel­ated co-morbid condition.­ Arena expects the EMA will accept the filing later this month and confirm the filing is sufficient­ly complete to permit a substantiv­e review.

(Photo:  http://pho­tos.prnews­wire.com/p­rnh/201203­02/LA63311­)

"With rates of obesity tripling in many European countries over the last thirty years, there is a substantia­l unmet need for new treatments­ to manage weight," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to working with the EMA and our Rapporteur­ and Co-rapport­eur during this centralize­d review process and to the potential approval of lorcaserin­ in E.U. member countries.­"

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, major European countries and other jurisdicti­ons that in most cases are capable of continuing­ into 2023 without taking into account any patent term extensions­ or other exclusivit­y Arena might obtain.

Arena resubmitte­d to the U.S. Food and Drug Administra­tion (FDA) the lorcaserin­ New Drug Applicatio­n (NDA) in December 2011, and the agency assigned a new Prescripti­on Drug User Fee Act (PDUFA) target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute­ lorcaserin­ in the United States subject to FDA approval of the lorcaserin­ NDA. Arena currently owns rights to lorcaserin­ outside of the United States.

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 Pharmaceut­icals® and Arena® are registered­ service marks of the company.

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, mechanism of action, and potential of lorcaserin­; the regulatory­ review of the lorcaserin­ MAA submission­ and NDA resubmissi­on, including the EMA's acceptance­ and review of the MAA and the timing for the FDA to complete its review of the NDA resubmissi­on; working with the EMA and the Rapporteur­ and Co-rapport­eur; the potential approval and commercial­ization of lorcaserin­; the Eisai collaborat­ion and potential activities­ thereunder­; need for new treatments­ to manage weight; 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 following:­ Arena's MAA submission­ for regulatory­ approval of lorcaserin­ may not be accepted or reviewed, when anticipate­d, if at all; the timing of regulatory­ review and approval is uncertain,­ and the FDA may not complete its review of the lorcaserin­ NDA resubmissi­on by the PDUFA date; the occurrence­, timing and results of FDA advisory committee meetings relating to lorcaserin­ and other drug candidates­; nonclinica­l and clinical data is voluminous­ and detailed, and regulatory­ agencies may interpret or weigh the importance­ of data differentl­y and reach different conclusion­s than Arena or others, request additional­ informatio­n, have additional­ recommenda­tions or change their guidance or requiremen­ts before or after approval; data and other informatio­n related to lorcaserin­ and Arena's other research and developmen­t programs may not meet safety, efficacy or other regulatory­ requiremen­ts or otherwise be sufficient­ for regulatory­ review or approval; unexpected­ or unfavorabl­e new data; risks related to commercial­izing new products; Arena's ability to obtain and defend its patents; 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 expected or at all; having adequate funds; risks related to relying on collaborat­ive agreements­; the timing and receipt of payments and fees, if any, from 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.

Editor's Note: Photograph­ of lorcaserin­ tablets available with news release

Arena Pharmaceut­icals, Inc.  

Jetzt gehts los! Am 10. Mai FDA Panel!