Orexigen - Alles nichts oder am 31.Januar

Beiträge: 46
Zugriffe: 8.866 / Heute: 1
Orexigen Therape. kein aktueller Kurs verfügbar
 
Orexigen - Alles nichts oder am 31.Januar cubiak
cubiak:

Orexigen - Alles nichts oder am 31.Januar

3
22.01.11 08:03
#1
FDA Panel hat Empfehlung im Dezember ausgesprochen!

PDUFA Date jetzt am 31.1.

+100% oder -60%

Alles drin!

Kurs heute: Knapp 9 Dollar.

Mögliches langfristiges Kursziel: 88 Dollar!
http://seekingalpha.com/article/...gen-s-fair-value-today?source=feed

Noch wer drin?

Habe mal ne mittelgroße Position seit Dezember aufgebaut.

Sollte gutes Chance-Risiko-Verhältnis aufweisen. Aber immer bei Biotechs. Ein schmaler Grad...Große Verluste müssen ausgehalten werden!

Gruss
-cubiak
20 Beiträge ausgeblendet.
Seite: Übersicht Alle 1 2


Orexigen - Alles nichts oder am 31.Januar butzerle
butzerle:

Kleiner Rebound läuft...

 
02.02.11 19:05
#22
falls jemand hier noch mit dabei ist....

rein technische Reaktion, aber immerhin
Orexigen - Alles nichts oder am 31.Januar butzerle
butzerle:

wird nachhaltiger

 
04.02.11 15:32
#23
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....
Orexigen - Alles nichts oder am 31.Januar ralfmv
ralfmv:

... und steigt weiter !

 
04.02.11 19:12
#24

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

Orexigen - Alles nichts oder am 31.Januar cubiak
cubiak:

Dead Cat Bounce

 
04.02.11 19:15
#25
Orexigen - Alles nichts oder am 31.Januar cubiak
cubiak:

Ganz ehrlich...

 
04.02.11 19:16
#26
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
Orexigen - Alles nichts oder am 31.Januar ralfmv
ralfmv:

cubiak, ich höre mal auf dich....

 
04.02.11 19:42
#27

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

Orexigen - Alles nichts oder am 31.Januar millemax
millemax:

hier machen einige einen fehler...

 
06.02.11 16:27
#28
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 - Alles nichts oder am 31.Januar Joschi307
Joschi307:

Orexigen 2,25 €

 
10.02.11 16:38
#29
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.
Der ARIVA.DE Newsletter
Bleiben Sie informiert mit dem
wöchentlichen Marktüberblick
von ARIVA.DE!
E-Mail-Adresse
Ich möchte Benachrichtigungen von ARIVA.DE erhalten.
Ja, ich habe die Datenschutzhinweise gelesen und akzeptiert (Pflichtfeld).
Orexigen - Alles nichts oder am 31.Januar Joschi307
Joschi307:

orexigen 1,92 €

 
24.04.11 12:21
#30
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.
Anzeige: Smartbroker
Orexigen Therapeutics-Aktie jetzt dauerhaft für 0€ handeln! + Aktienhandel für 0€

+ Derivatehandel für 0€
+ Kostenlose Sparpläne
+ Keine Depotgebühren

Jetzt KOSTENLOS handeln auf
www.smartbroker.de
Orexigen - Alles nichts oder am 31.Januar Balu4u
Balu4u:

Geht ganz schön ab heute

 
21.09.11 19:54
#31
Orexigen - Alles nichts oder am 31.Januar ChrisChris
ChrisChris:

Und wie!

 
21.09.11 19:55
#32
Orexigen - Alles nichts oder am 31.Januar Balu4u
Balu4u:

Grund des Anstieges!?

 
21.09.11 20:29
#33

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

Orexigen - Alles nichts oder am 31.Januar Bob der Bob
Bob der Bob:

kauf 5,55

 
11.12.13 19:17
#35
hier kommt was! Stichwort Contrave Zulassung.
Orexigen - Alles nichts oder am 31.Januar nordvendt
nordvendt:

q3 zahlen als wiedereinstieg

 
10.11.14 13:59
#36
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: www.twst.com

bin mal mit einer kleinen position dabei...
Orexigen - Alles nichts oder am 31.Januar nordvendt
nordvendt:

sieht gut aus

 
10.11.14 14:16
#37
Erwartungen übertroffen, Profit hoch, nächste EU-Zulassung in Aussicht, weitere Meilensteinzahlung...wüsste nicht, warum es mittelfristig nicht wieder nach oben gehen sollte,  
Orexigen - Alles nichts oder am 31.Januar nordvendt
nordvendt:

seeking alpha dreht das fähnchen im wind

 
10.11.14 19:29
#38

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!
Orexigen - Alles nichts oder am 31.Januar ellogo2
ellogo2:

news

 
19.12.14 16:20
#39
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
Orexigen - Alles nichts oder am 31.Januar wallander
wallander:

wow!

 
03.03.15 17:05
#40
Orexigen - Alles nichts oder am 31.Januar hAraldchef
hAraldchef:

wieso?

 
03.03.15 18:18
#41
steigt orexigen heute so stark?
Orexigen - Alles nichts oder am 31.Januar jonzweit
jonzweit:

Re:

 
03.03.15 18:46
#42
einfach rein
Orexigen - Alles nichts oder am 31.Januar Cephei
Cephei:

Harald

 
03.03.15 19:03
#43
Wegen aktuellem 8K
Orexigen - Alles nichts oder am 31.Januar ellogo2
ellogo2:

news

 
20.04.15 14:02
#44
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.
Orexigen - Alles nichts oder am 31.Januar NikGol
NikGol:

OREX

 
18.07.15 18:40
#45
.
(Verkleinert auf 81%) vergrößern
Orexigen - Alles nichts oder am 31.Januar 842039
Orexigen - Alles nichts oder am 31.Januar NikGol

OREX

 
#46
4.3 $ ist durch - Short Signal  

Seite: Übersicht Alle 1 2

Hot-Stocks-Forum - Gesamtforum - Antwort einfügen - zum ersten Beitrag springen

Neueste Beiträge aus dem Orexigen Therapeutics Forum

  

--button_text--