ARNA - Arena Pharmaceuticals
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
Gibt es wieder mal Insiderhandel?
Ohne News und einfach nur so steigt der Kurs.....
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| Boardmail an "karl79" |
Wertpapier: Arena Pharmaceuticals |
http://www.savvystockpicks.com/stock-updates/...d811-drug-nasdaqarna/
Von der Zielstellung dieser Phase 1 -Indikation habe ich aber keine Ahnung ...
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| Boardmail an "karl79" |
Wertpapier: Arena Pharmaceuticals |
Wenn das also nicht klappt mit der zulassung ,seht ihr -95% an einem Tag !!
MFG
Chali
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| Boardmail an "Chalifmann3" |
Wertpapier: Arena Pharmaceuticals |
$ 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
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Wertpapier: Arena Pharmaceuticals |
Angehängte Grafik:
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bis dahin gilt.. the trend is your friend ;-)
http://stockcharts.com/charts/gallery.html?s=arna
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
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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 $1.69 N/A
TODAY'S RAiDAR HEADLINES for ARNA:
12/20/2010 15:17 Closing Update: S&P, Nasdaq End Just Firmer But Dow Lags - midnight trader
12/20/2010 15:17 Stocks End Mixed But S&P and Nasdaq End at Two-Year Highs - knobias
12/20/2010 15:01 Knobias Sector Commentary - knobias
12/20/2010 11:40 Mid-Day Update: Stocks Mixed as Optimism from Tax Cut Fades, Euro Debt Weighs - midnight trader
12/20/2010 08:14 Stocks Look to Get Early Boost From Deal News - midnight trader
12/17/2010 15:16 Stocks End Quadruple Witching Expiration Day Near Flat Line - knobias
12/17/2010 14:59 Knobias Sector Commentary - knobias
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Die letzten Wochen ziemlich gute Entwicklung der Aktie, hält sich schön über den 2$.
Bin sehr gespannt wie sich Arena dieses Jahr entwickelt. Vielleicht boxen wir Lorc ja doch noch auf den Markt.
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]
Optionen
| Boardmail an "karl79" |
Wertpapier: Arena Pharmaceuticals |
MFG
Chali
Optionen
| Boardmail an "Chalifmann3" |
Wertpapier: Arena Pharmaceuticals |
"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.
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.
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.