Sellas Life Sciences Group (ehemals Galena Biopharma) (Seite 206)
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ISIN: US81642T2096 · WKN: A2PU3T · Symbol: SLS
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| 2,25 | +63,04 | |
| 0,8000 | +45,45 | |
| 1,0000 | +42,86 | |
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| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 114,60 | -13,61 | |
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| 0,7800 | -29,73 |
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Was bedeutet dieser Brief denn genau?
für mich ist das Chancen/Risiko Verhältnis leider gestiegen!
ohh! das sieht gar nicht gut aus! Verlust je Aktie doch größer als geplant?
Galena Biopharma (GALE) Receives FDA Warning Letter, Not Expected to Impact Guidance
http://www.streetinsider.com/Corporate+News/Galena+Biopharma…" target="_blank" rel="nofollow ugc noopener">http://www.streetinsider.com/Corporate+News/Galena+Biopharma…As previously reported by Galena Biopharma (NASDAQ: GALE) in its Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 5, 2015 following an inspection, of our Portland, Oregon facility in November 2014, the U.S. Food and Drug Administration (the “FDA”) issued a Form 483 Notice of Inspectional Observations (the “Form 483 Notice”) noting deficiencies pertaining to post-marketing adverse drug experience reporting and current good manufacturing practices for Abstral and Zuplenz, our only approved products. We responded to the Form 483 Notice in a letter dated December 11, 2014. In conjunction with our response to the FDA, we initiated a number of programs and corrective actions to address the FDA's observations.
On April 6, 2015, we received a Warning Letter from the FDA relating to certain of the matters originally identified in the Form 483 Notice. Specifically, the Warning Letter cites deficiencies in our response letter related to the adequacy of our written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences from all sources, and the failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals.
The Warning Letter will be posted on the FDA’s website at www.fda.gov and, once posted, will be available for viewing. We have 15 business days to respond to the Warning Letter, and intend to fully respond in a timely manner.
We do not expect any interruption in our commercial operations or impact on our 2015 financial guidance as a result of the Warning Letter. However, we cannot give any assurances that the FDA will be satisfied with our response to the Warning Letter or our proposed resolution of the outstanding issues cited by the FDA
Nice....
Can Galena Biopharma (GALE) Keep the Earnings Streak Alive This Quarter? - Tale of the Tape
Looking for a stock that might be in a good position to beat earnings at its next report? Consider Galena Biopharma, Inc. (GALE), a firm in the Medicine-Biomedicine/Genetic industry, which could be a great candidate for another beat.
This company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. In fact, in these reports, GALE has beaten estimates by at least 15% in both cases, suggesting it has a nice short-term history of crushing expectations
This is particularly true when you consider that GALE has a great Zacks Rank #2 (Buy) which can be a harbinger of outperformance and a signal for a strong earnings profile. And when you add this solid Zacks Rank to a positive Earnings ESP, a positive earnings surprise happens nearly 70% of the time, so it seems pretty likely that GALE could see another beat at its next report, especially if recent trends are any guide
http://finance.yahoo.com/news/galena-biopharma-gale-keep-ear…
...Time will tell
Can Galena Biopharma (GALE) Keep the Earnings Streak Alive This Quarter? - Tale of the Tape
Looking for a stock that might be in a good position to beat earnings at its next report? Consider Galena Biopharma, Inc. (GALE), a firm in the Medicine-Biomedicine/Genetic industry, which could be a great candidate for another beat.
This company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. In fact, in these reports, GALE has beaten estimates by at least 15% in both cases, suggesting it has a nice short-term history of crushing expectations
This is particularly true when you consider that GALE has a great Zacks Rank #2 (Buy) which can be a harbinger of outperformance and a signal for a strong earnings profile. And when you add this solid Zacks Rank to a positive Earnings ESP, a positive earnings surprise happens nearly 70% of the time, so it seems pretty likely that GALE could see another beat at its next report, especially if recent trends are any guide
http://finance.yahoo.com/news/galena-biopharma-gale-keep-ear…
...Time will tell
Trading Spotlight
Antwort auf Beitrag Nr.: 49.520.792 von Growth2012 am 08.04.15 20:38:32GALE Agenda Übersicht-(etwas vertieft)- April-Mai:-
Apr 14, 2015
10:40 AM ET 14th Annual Needham Healthcare Conference (Hier präsentiert CEO Schwartz höchstpersönlich...kommen hier Neuerigkeiten beim Doppelauftritt am gleichen Tag?!?)
Location: New York, NY
http://investors.galenabiopharma.com/events.cfm
April 14, 2015
(highflier2go)
Elizabeth Mittendorf will discuss Neuvax trials
Breast Cancer Immunotherapy Symposium (BRECIS) in Doha, Qatar
http://sidrasitcqatar.com/
http://sidrasitcqatar.com/wp-content/uploads/2015/03/mittend…
April 28, 2015
(rocketjock1)
Judge's decision coming up
Class Action Suit Update - Oregon Federal Court
https://sites.google.com/site/rocketbusinessandfinance/
(ein mögliche Freispruch wurde "The funny money gang" (Biotech Fonds), wieder grünes Licht signalisieren um hier erneut bedenklos einzusteigen...Blackrock (der größte Fond/Private Equity Fa. Weltweit) ist übrigens jetzt schon-auf kleine Flamme- dabei )
May 4, 2015
Keynote Presentations
Injecting Hope: Clinical Development of the NeuVax Breast Cancer Vaccine
Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor and Deputy Chair, Research, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center
http://www.ibclifesciences.com/TIDES/plenary.xml
May 7, 2015
Q1 2015 Galena Biopharma Inc Earnings Release (Tentative) - 4:00PM EDT
...ich denke die endlose bashers- (und zumteil eigenes verschuldete miese GALE PR aus 2014) bietet ein sehr guten KGV verhältnis für neueinsteiger an zurzeit
Apr 14, 2015
10:40 AM ET 14th Annual Needham Healthcare Conference (Hier präsentiert CEO Schwartz höchstpersönlich...kommen hier Neuerigkeiten beim Doppelauftritt am gleichen Tag?!?)
Location: New York, NY
http://investors.galenabiopharma.com/events.cfm
April 14, 2015
(highflier2go)
Elizabeth Mittendorf will discuss Neuvax trials
Breast Cancer Immunotherapy Symposium (BRECIS) in Doha, Qatar
http://sidrasitcqatar.com/
http://sidrasitcqatar.com/wp-content/uploads/2015/03/mittend…
April 28, 2015
(rocketjock1)
Judge's decision coming up
Class Action Suit Update - Oregon Federal Court
https://sites.google.com/site/rocketbusinessandfinance/
(ein mögliche Freispruch wurde "The funny money gang" (Biotech Fonds), wieder grünes Licht signalisieren um hier erneut bedenklos einzusteigen...Blackrock (der größte Fond/Private Equity Fa. Weltweit) ist übrigens jetzt schon-auf kleine Flamme- dabei
) May 4, 2015
Keynote Presentations
Injecting Hope: Clinical Development of the NeuVax Breast Cancer Vaccine
Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor and Deputy Chair, Research, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center
http://www.ibclifesciences.com/TIDES/plenary.xml
May 7, 2015
Q1 2015 Galena Biopharma Inc Earnings Release (Tentative) - 4:00PM EDT
...ich denke die endlose bashers- (und zumteil eigenes verschuldete miese GALE PR aus 2014) bietet ein sehr guten KGV verhältnis für neueinsteiger an zurzeit
Ab Mitte April dürfen wir ständig news erwarten, mit "volldampf" ins rebound Modus.
Ein paar Beispiele 'to go'...
Elizabeth Mittendorf will discuss Neuvax trials on April 14, 2015 09:25-09:45 local time Doha, Quatar
(Breast Cancer Immunotherapy Symposium (BRECIS) in Doha, Qatar)
Abstract: Clinical Development of HER2-Derived Peptide Vaccines in Breast Cancer
NeuVax is a major histocompatibility complex (MHC) class I peptide vaccine consisting
of the E75 epitope derived from the HER2 protein’s extracellular domain mixed with the immunoadjuvant GM-CSF. Phase I/II studies showed NeuVax to be safe and able to
stimulate an antigen-specific immune response. In addition, there was an approximately 50% reduction in relative recurrence risk in 108 vaccinated patients compared with 79 unvaccinated controls. Based on these encouraging data, NeuVax is currently being evaluated in a phase III registration trial. This presentation will focus on the early phase trials evaluating NeuVax as well as an update of the phase III trial and additional studies evaluating a novel combination immunotherapy strategy combining the vaccine with trastuzumab. In addition, phase II trials evaluating GP2, a second MHC class I vaccine and AE37, an MHC class II vaccine have recently reported their primary endpoint analyses and these results will be discussed.
CEO Schwartz (am gleichen Tag) in New York
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the 14th Annual Needham Healthcare Conference. The presentation will take place on Tuesday, April 14, 2015 at 10:40 a.m. ET at The Westin Grand Central Hotel in New York, NY.
...ich habe irgendwie das dumpfe Gefühl sie haben "einiges" berichtungswürdiges auf Lager zurzeit, und ab Mitte April wird GALE erstmalig 2015 wieder redselig
Ein paar Beispiele 'to go'...
Elizabeth Mittendorf will discuss Neuvax trials on April 14, 2015 09:25-09:45 local time Doha, Quatar
(Breast Cancer Immunotherapy Symposium (BRECIS) in Doha, Qatar)
Abstract: Clinical Development of HER2-Derived Peptide Vaccines in Breast Cancer
NeuVax is a major histocompatibility complex (MHC) class I peptide vaccine consisting
of the E75 epitope derived from the HER2 protein’s extracellular domain mixed with the immunoadjuvant GM-CSF. Phase I/II studies showed NeuVax to be safe and able to
stimulate an antigen-specific immune response. In addition, there was an approximately 50% reduction in relative recurrence risk in 108 vaccinated patients compared with 79 unvaccinated controls. Based on these encouraging data, NeuVax is currently being evaluated in a phase III registration trial. This presentation will focus on the early phase trials evaluating NeuVax as well as an update of the phase III trial and additional studies evaluating a novel combination immunotherapy strategy combining the vaccine with trastuzumab. In addition, phase II trials evaluating GP2, a second MHC class I vaccine and AE37, an MHC class II vaccine have recently reported their primary endpoint analyses and these results will be discussed.
CEO Schwartz (am gleichen Tag) in New York
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the 14th Annual Needham Healthcare Conference. The presentation will take place on Tuesday, April 14, 2015 at 10:40 a.m. ET at The Westin Grand Central Hotel in New York, NY.
...ich habe irgendwie das dumpfe Gefühl sie haben "einiges" berichtungswürdiges auf Lager zurzeit, und ab Mitte April wird GALE erstmalig 2015 wieder redselig
Antwort auf Beitrag Nr.: 49.508.831 von tancho am 07.04.15 15:36:58Dir ist hoffentlich klar das Sean Williams ein bezahlte Gale basher ist, oder?
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong , track every pick he makes under the screen name TrackUltraLong , and check him out on Twitter, where he goes by the handle @TMFUltraLong . The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Siehe auch Beitrag Nr. 880 hier im Forum für weitere Williams spinnerei (seine bash versuche sind so unverblümt offensichtlich dass ich fast darüber lachen muss)
http://www.investopedia.com/stock-analysis/033115/4-ways-gal…
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong , track every pick he makes under the screen name TrackUltraLong , and check him out on Twitter, where he goes by the handle @TMFUltraLong . The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .
Siehe auch Beitrag Nr. 880 hier im Forum für weitere Williams spinnerei (seine bash versuche sind so unverblümt offensichtlich dass ich fast darüber lachen muss)
http://www.investopedia.com/stock-analysis/033115/4-ways-gal…
Antwort auf Beitrag Nr.: 49.508.831 von tancho am 07.04.15 15:36:58Schau mal hier:
https://clinicaltrials.gov/ct2/show/NCT01479244?term=neuvax&…
https://clinicaltrials.gov/ct2/show/NCT01570036?term=neuvax&…
https://clinicaltrials.gov/ct2/show/NCT02297698?term=neuvax&…
Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)
Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (HER3+)
Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/NCT01479244?term=neuvax&…
https://clinicaltrials.gov/ct2/show/NCT01570036?term=neuvax&…
https://clinicaltrials.gov/ct2/show/NCT02297698?term=neuvax&…
Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)
Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (HER3+)
Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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