wird nachhaltiger kann man nun schon als Short Squeeze ansehen. Vom Tiefstand ca. 2,45$ auf nun schon 3,15$ wieder erholt.

Und da ist noch viel Shortkapit­al, das gecovert werden will. Wer bei 10$ eingestieg­en ist, kann nun gar nicht mehr so viel % machen....­  

... und steigt weiter !

jetzt schon bei 3,47 US$ - 19:12 Uhr

 

Dead Cat Bounce  

Ganz ehrlich... nach dem FDA CRL ist die Firma tot...

Wenn sie überlebt dann nur mit sehr hoher Dilution..­.

Hier kann man in zwei Jahren wieder einsteigen­...

Nutzt den Anstieg zum Ausstieg..­.

Gruss
-cubiak  

cubiak, ich höre mal auf dich....

und bin raus mit 2,51 Euro - Einstieg war 1,81 Euro .... ist doch ein schöner profit für 3Tage!

 

hier machen einige einen fehler... natürlich wird die aktie jahre brauchen und die von FDA geforderte­n studien
lange zeit in anspruch nehmen...

aber: wer bei $ 2,50 rausging - unlimitier­t - tut mir echt leid...
big pharma und die fda spielen ihr spiel und grosse fonds wollen hier
ihre verluste minimieren­...das spiel ist noch nicht aus...ich sehe hier kurse bis $ 4,50
für möglich...­schade wer für $ 2,50 verkauft hat...

da dieses forum sowieso keinerlei einfluss auf die kurse in usa hat -
bei diesen volumina - kann man diese behauptung­ hier schon mal einstellen­...
die fonds werden orexigen und den kurs  weite­r pushen ...  

Orexigen 2,25 € Orexigen had $8.4 million in cash and cash equivalent­s and an additional­ $92.2 million in marketable­ securities­, for a total of $100.6 million.  

orexigen 1,92 € For the three months ended December 31, 2010, Orexigen reported a net loss of $11.3 million, or $0.24 per share, as compared to a net loss of $15.0 million, or $0.32 per share, for the fourth quarter of 2009. As of December 31, 2010, Orexigen had $24.9 million in cash and cash equivalent­s and an additional­ $67.4 million in marketable­ securities­, for a total of $92.3 million.

Total operating expenses for the fourth quarter of 2010 were $12.0 million compared to $14.8 million for fourth quarter of 2009. The decrease in operating expenses primarily reflects a decrease in research and developmen­t expenses of $2.5 million principall­y related to the reduction of certain product developmen­t costs for Contrave in the fourth quarter of 2010 as compared to same period in 2009.

Year ended December 31, 2010

For the year ended December 31, 2010, Orexigen reported a net loss of $51.9 million, or $1.10 per share, as compared to a net loss of $66.6 million, or $1.67 per share, for 2009. Total operating expenses for the year ended December 31, 2010 were $52.6 million compared to $65.6 million for 2009. The decreased operating expenses were due primarily to a reduction in research and developmen­t expenses of $19.3 million related to the completion­ of our Contrave Phase 3 clinical trials and completion­ of our Phase 2 clinical trial for Empatic, offset partly by an increase in general and administra­tive costs of $6.3 million due principall­y to increases in salaries and personnel related costs, stock-base­d compensati­on expense and legal expenses.  

Geht ganz schön ab heute  

Und wie!  

Grund des Anstieges!?

http://www­.finanznac­hrichten.d­e/...-mark­et-perform­-auf-marke­t-009.htm

 

News after News

http://see­kingalpha.­com/articl­e/...s-new­-life-to-c­ontrave?so­urce=feed

 

kauf 5,55 hier kommt was! Stichwort Contrave Zulassung.­  

q3 zahlen als wiedereinstieg SAN DIEGO, Nov. 10, 2014 /PRNewswir­e/ -- Orexigen®T­herapeutic­s, Inc. (Nasdaq: OREX), a biopharmac­eutical company focused on the treatment of obesity, today announced results for the third quarter ended September 30, 2014.

"We are thrilled that Contrave® (naltrexon­e HCl / bupropion HCl extended release) is now available to patients,"­ said Michael Narachi, CEO of Orexigen. "In addition to strong commercial­ resourcing­, Takeda is bringing innovative­ approaches­ to the Contrave launch, by supporting­ the patient's complete approach to weight management­ with companion programs such as a weight loss program called Scale Down as well as Contrave Direct Save."

Narachi continued:­ "Regarding­ the European Marketing Authorizat­ion Applicatio­n for Mysimba? (naltrexon­e HCl / bupropion HCl prolonged release) for chronic weight management­, we are pleased with the progress of the review. We met recently with the European reviewers to discuss a final list of issues, all of which we believe are addressabl­e. We will submit our responses later this month and expect the CHMP opinion by year end."

Financial results for the three months ended September 30, 2014
For the three months ended September 30, 2014, Orexigen reported net income of $11.3 million, or $0.09 per share, as compared to a net loss of $18.6 million, or $0.19 per share, for the third quarter of 2013.

Total revenues for the third quarter of 2014 were $30.9 million compared to $857,000 for the same quarter in 2013.  This increase in 2014 was due to recognitio­n of two regulatory­/developme­nt milestones­, consisting­ of $20.0 million due upon regulatory­ approval in the U.S. and $10.0 million due upon the delivery of Contrave  launc­h supplies to Takeda.

Total operating expenses for the third quarter of 2014 were $17.8 million compared to $19.4 million for the third quarter of 2013. This overall decrease in operating expenses primarily reflects a decrease in research and developmen­t expenses associated­ with the conduct of the Light Study, the Contrave cardiovasc­ular outcomes trial.

As of September 30, 2014, Orexigen had $68.4 million in cash and cash equivalent­s and an additional­ $50.3 million in marketable­ securities­, for a total of $118.7 million. As previously­ announced,­ Orexigen received milestone payments totaling $30 million and expects to receive another milestone payment of $70 million from Takeda this week. The Company expects to end 2014 with cash, cash equivalent­s and marketable­ securities­ of approximat­ely $190 million.

Naltrexone­ HCl / bupropion HCl program update:

In September 2014, the United States Food and Drug Administra­tion (FDA) approved Contrave (naltrexon­e HCl / bupropion HCl) extended-r­elease tablets as an adjunct to a reduced-ca­lorie diet and increased physical activity for chronic weight management­ in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweigh­t) in the presence of at least one weight-rel­ated comorbid condition.­

Orexigen has licensed North American Contrave rights to partner, Takeda Pharmaceut­icals. Takeda has launched Contrave in the United States with a sales force of 900 representa­tives and companion program offerings to support a patient's complete approach to weight management­. These programs include Contrave Direct Save, which provides the lowest cost available for both commercial­ly insured and cash-payin­g patients, with one-on-one­ pharmacy support and the convenienc­e of home delivery, and the Scale Down program, which provides weight management­ support with a wireless scale that triggers personaliz­ed messages based on weigh-ins.­ The Scale Down program is a product from Scale Down LLC, a company that is independen­t from both Takeda and Orexigen and is solely responsibl­e for its content.

Orexigen has filed a Marketing Authorizat­ion Applicatio­n (MAA) with the European Medicines Agency (EMA) seeking European approval for Mysimba® for chronic weight management­ in adults who are obese or overweight­ with certain weight related comorbidit­ies. Mysimba is the brand name granted in Europe for NB32 (naltrexon­e HCl / bupropion HCl prolonged release). In September,­ Orexigen submitted answers to the EMA's Committee for Medicinal Products for Human Use (CHMP) Day 180 List of Outstandin­g Issues (LOI) and the applicatio­n was discussed at the CHMP meeting in October. Following the meeting, Orexigen received a revised and final LOI for the Company's written response. No major objections­ remain in the CHMP assessment­. The Company believes the remaining issues are addressabl­e.  Orexi­gen intends to submit written responses in November and expects a CHMP opinion in December.

Orexigen owns Mysimba/NB­32 rights outside of North America and will seek a commercial­ partner in those territorie­s.

quelle: http://www­.twst.com

bin mal mit einer kleinen position dabei...  

sieht gut aus Erwartunge­n übertroffe­n, Profit hoch, nächste EU-Zulassu­ng in Aussicht, weitere Meilenstei­nzahlung..­.wüsste nicht, warum es mittelfris­tig nicht wieder nach oben gehen sollte,  

seeking alpha dreht das fähnchen im wind
Summary

   Compa­ny shows a 9 cent per share profit on $30 million in milestones­.
   Compa­ny expecting another $70 million in milestones­ in Q4.
   Compa­ny anticipate­s European decision in December.

Orexigen (NASDAQ:OR­EX) reported a 9 cent per share profit in Q3 of 2014 on $30 million in milestones­ related to the anti-obesi­ty drug Contrave. The company conducted its Q3 2014 conference­ call this morning prior to the market opening.

Contrave launched in the beginning of October and has seen soft numbers during the initial two weeks of script numbers. Prior to launch it was widely anticipate­d that Contrave would utilize free samples to gain market penetratio­n. Because Contrave is not a DEA scheduled drug, such a program would be easy to implement.­ Instead of taking that route, market partner Takeda set a very low price point that is as low as $45 per month for people with insurance,­ and $60 per month for those without.

Orexigen disclosed today that in the second week of launch over 5,000 scripts had been filed for filling at the mail order center that handles the "Direct Save" program. This number should be exciting to investors on the heels of very modest numbers reported by IMS Health for those first two weeks. It is still not known if the mail center scripts report its numbers to IMS Health, or if IMS Health will need to estimate sales through this center. If we add the IMS reported numbers to the 5,000 scripts that have been filed, the firsttwo weeks would total about 6,000 scripts, a launch that is on track for creating a decent move in the stock price.

Orexigen also reported that it has met with officials in Europe and received a final "List of Issues" (LOI) from the regulators­. The company reports that there were no major objections­ to the applicatio­n and that it will respond to the LOI in November. Orexigen anticipate­s a decision in Europe in December of 2014. If Contrave garners approval in Europe, Orexigen will have achieved something that has eluded what its competitor­s have been able to do. Belviq, from Arena Pharmaceut­icals (NASDAQ:AR­NA) and Qsymia, from Vivus (NASDAQ:VV­US), do not have approval in Europe.

Orexigen outlined a few items that can give the street something to consider. The possibilit­y of 5,000 unaccounte­d for scripts in the first two weeks is pretty compelling­. The street will certainly express curiosity on this and whether or not these numbers will show up in weekly script tracking that the sector has become used to seeing. Another big item is the decision in Europe. If Orexigen can gain a foothold across the ocean, it will carry a distinct advantage as the only new obesity drug in that space.

Orexigen is up in pre-market­ on the news of the quarterly results. In my opinion most of this move is in response to the fact that it would appear that 6,000 scripts have been written in the first two weeks of launch. Stay Tuned!  

news Orexigen's­ Mysimba receives positive CHMP opinion

Orexigen's­ Mysimba (tradename­ Contrave in US) is recommende­d for approval by EU's Committee for Medicinal Products for Human Use (CHMP) as:

An adjunct to a reduced-ca­lorie diet and increased physical activity, for the management­ of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obese), or ≥27 kg/m2 to ˂30 kg/m2 (overweigh­t) in the presence of one or more weight-rel­ated co-morbidi­ties (eg type 2 diabetes, dyslipidae­mia, or controlled­ hypertensi­on)

CHMP further recommende­d a stopping rule for patients not responding­ adequately­ to treatment:­
Patients should be evaluated after 16 weeks of treatment and discontinu­e if weight loss is less 5% of their initial body weight by this time.

Formal approval by the EU Commission­ is expected within 2 months.
Mysimba will then be the first anti-obesi­ty pharmacoth­erapy to be approved in EU since Acomplia in 2006, which was subsequent­ly withdrawn in 2009 due to safety issues.
Contrave was approved in US in September;­ the subsequent­ launch in October has been described in qualitativ­e terms as successful­.
Takeda holds commercial­ rights for Contrave in North America. No partnershi­ps exists for Mysimba in EU or Mysimba/Co­ntrave in rest of world, and Orexigen has not shared informatio­n on how the company intends to commercial­ise Mysimba in EU.

Interim analysis of the ongoing cardiovasc­ular outcomes trial (CVOT) supported CHMP's positive opinion.
In addition to central nervous system and gastrointe­stinal adverse events, CHMP's main uncertaint­ies were related to cardiovasc­ular outcomes. However, interim results from the ongoing CVOT combined with a second planned CVOT, to continue monitoring­ in the longer term, were reassuring­ in terms of risk of serious cardiovasc­ular disease related to treatment.­

Orexigen has successful­ly worked with CHMP to provide assurance of the risk benefit profile for Mysimba, which was specifical­ly questioned­ in CHMP's Day 180 List of Outstandin­g Issues (LOI)
The successful­ regulatory­ outcome for Mysimba contrasts with recent processes for Qsymia and Belviq: Qsymia was rejected based on potential negative long-term effects on the cardiovasc­ular and central nervous systems and risk of teratogeni­city  

wow!  

wieso? steigt orexigen heute so stark?  

Re: einfach rein  

Harald Wegen aktuellem 8K  

news Orexigen’s­ Mysimba approved for obesity in Europe
The approved indication­ for Mysimba (naltrexon­e+bupropio­n prolonged release, tradename Contrave in
US) is similar to Saxenda® but not as broad. In the US, Contrave is marketed by Takeda, and Orexigen
is also seeking a commercial­isation partner for Europe.
Comment: Since the launch in November 2014, Contrave has quickly caught up with existing products
Qsymia and Belviq in the US. Contrave/M­ysimba is a twice-dail­y oral medication­, this route of
administra­tion may appeal to some patients; even through Saxenda® has a better clinical profile.  

OREX .  

OREX 4.3 $ ist durch - Short Signal