Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 329)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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20.07.23 · Business Wire (engl.)  |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8000 | +45,45 | |
| 1,0000 | +42,86 | |
| 3,0000 | +42,18 | |
| 6,2500 | +24,75 | |
| 1,2420 | +23,83 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,3200 | -16,98 | |
| 23,700 | -19,52 | |
| 28,60 | -24,06 | |
| 1,3500 | -25,62 | |
| 0,7800 | -29,73 |
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was ist blos mit sppi los die bios kennen nur den weg nach oben und sppi 
da ist doch irgendwas oberfaul
da ist doch irgendwas oberfaul
Antwort auf Beitrag Nr.: 36.810.726 von Magnetfeldfredy am 20.03.09 12:22:03und was bringts ????
Antwort auf Beitrag Nr.: 36.781.066 von Ville7 am 17.03.09 10:29:02Bay Rating!
New York (aktiencheck.de AG) - Shiv Kapoor, Analyst von Morgan Joseph & Co, stuft die Aktie von Spectrum Pharmaceuticals (ISIN US84763A1088/ WKN 164623) mit dem Rating "buy" ein. (18.03.2009/ac/a/u)
New York (aktiencheck.de AG) - Shiv Kapoor, Analyst von Morgan Joseph & Co, stuft die Aktie von Spectrum Pharmaceuticals (ISIN US84763A1088/ WKN 164623) mit dem Rating "buy" ein. (18.03.2009/ac/a/u)
Nur Geduld. Heute abend gibts eine Company Presentation:
Cowen and Company Healthcare Conference
Tuesday March 17, 2009
4:30 PM EST/1:30 PM PST
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=SPP…
Cowen and Company Healthcare Conference
Tuesday March 17, 2009
4:30 PM EST/1:30 PM PST
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=SPP…
jetzt sollten sie auch langsam mal das cti von der zevalin - seite nehmen :-)
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Antwort auf Beitrag Nr.: 36.772.688 von Ville7 am 16.03.09 10:50:43News:
Press Release Source: Spectrum Pharmaceuticals
Spectrum Pharmaceuticals Acquires 100% of ZEVALIN®, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Monday March 16, 7:00 am ET
2008 ZEVALIN Sales Were Approximately $11.4 Million
Spectrum Will Book 100% of ZEVALIN Sales Moving Forward
PDUFA Action Date for ZEVALIN in First-Line Use is July 2, 2009
Multiple Synergies Anticipated With FUSILEV™
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM:SPPI - News) announced today the closing of the transaction whereby Spectrum Pharmaceuticals acquired 100% control of RIT Oncology, LLC™, to commercialize ZEVALIN® ([90Y]-ibritumomab tiuxetan) in the United States. In connection with the closing, Spectrum Pharmaceuticals will pay its former partner a total of $16.5 million, which is subject to further adjustments based on outstanding liabilities and obligations. Additionally, there will be no further payments or milestones to the former partner. Spectrum Pharmaceuticals now has 100% ownership of RIT Oncology, LLC, and will be responsible for all activities relating to ZEVALIN. Spectrum Pharmaceuticals will now book 100% of ZEVALIN revenues.
ADVERTISEMENT
ZEVALIN is currently approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. ZEVALIN is under review by the FDA for use as a first line consolidation therapy for patients with NHL. The FDA recently established July 2, 2009 as a target date for a decision regarding the ZEVALIN sBLA.
“We are excited to have 100% ownership of ZEVALIN,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Recent clinical data have dramatically underscored the clinical benefits of ZEVALIN in NHL. We believe that approval of the supplemental Biologics License Application (sBLA) for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to ZEVALIN.”
“The anticipated FDA approval of the sBLA for ZEVALIN on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population,” added Dr. Shrotriya. “We expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for ZEVALIN in July. This asset, along with FUSILEV™, creates added synergies across multiple cost centers, thereby maximizing the return on our investments.”
On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as a first line consolidation therapy for patients with NHL. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted. A Prescription Drug User Fee Act (PDUFA) target date of July 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.
If approved, ZEVALIN would be the first therapeutic available to patients as first-line consolidation therapy to treat NHL. Following the anticipated approval, the addressable patient population would increase by approximately 18,000. Together with ZEVALIN's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients that are rituximab-refractory or rituximab-naive, approval of ZEVALIN as first-line consolidation therapy may allow ZEVALIN to be used in several lines of NHL therapy.
Press Release Source: Spectrum Pharmaceuticals
Spectrum Pharmaceuticals Acquires 100% of ZEVALIN®, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Monday March 16, 7:00 am ET
2008 ZEVALIN Sales Were Approximately $11.4 Million
Spectrum Will Book 100% of ZEVALIN Sales Moving Forward
PDUFA Action Date for ZEVALIN in First-Line Use is July 2, 2009
Multiple Synergies Anticipated With FUSILEV™
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM:SPPI - News) announced today the closing of the transaction whereby Spectrum Pharmaceuticals acquired 100% control of RIT Oncology, LLC™, to commercialize ZEVALIN® ([90Y]-ibritumomab tiuxetan) in the United States. In connection with the closing, Spectrum Pharmaceuticals will pay its former partner a total of $16.5 million, which is subject to further adjustments based on outstanding liabilities and obligations. Additionally, there will be no further payments or milestones to the former partner. Spectrum Pharmaceuticals now has 100% ownership of RIT Oncology, LLC, and will be responsible for all activities relating to ZEVALIN. Spectrum Pharmaceuticals will now book 100% of ZEVALIN revenues.
ADVERTISEMENT
ZEVALIN is currently approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. ZEVALIN is under review by the FDA for use as a first line consolidation therapy for patients with NHL. The FDA recently established July 2, 2009 as a target date for a decision regarding the ZEVALIN sBLA.
“We are excited to have 100% ownership of ZEVALIN,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Recent clinical data have dramatically underscored the clinical benefits of ZEVALIN in NHL. We believe that approval of the supplemental Biologics License Application (sBLA) for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to ZEVALIN.”
“The anticipated FDA approval of the sBLA for ZEVALIN on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population,” added Dr. Shrotriya. “We expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for ZEVALIN in July. This asset, along with FUSILEV™, creates added synergies across multiple cost centers, thereby maximizing the return on our investments.”
On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as a first line consolidation therapy for patients with NHL. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted. A Prescription Drug User Fee Act (PDUFA) target date of July 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.
If approved, ZEVALIN would be the first therapeutic available to patients as first-line consolidation therapy to treat NHL. Following the anticipated approval, the addressable patient population would increase by approximately 18,000. Together with ZEVALIN's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients that are rituximab-refractory or rituximab-naive, approval of ZEVALIN as first-line consolidation therapy may allow ZEVALIN to be used in several lines of NHL therapy.
Die Zahlen müssten diese oder nächste Woche kommen. Um Mitte März herum war immer der Zeitpunkt für die Q4-/Vorjahreszahlen.
Yo! i m back!
Wann kommen die Q4 Zahlen raus? Hoffe euch geht es allen gut!
Wer hat den Streit gewonnen, Ville oder VaJo? oder keiner oder wie?
Wann kommen die Q4 Zahlen raus? Hoffe euch geht es allen gut!
Wer hat den Streit gewonnen, Ville oder VaJo? oder keiner oder wie?
Gibt es irgendwelche Einnahmen eigentlich noch aus satraplatin, falls es doch noch zur marktreife geführt werden würde????
Einer eine Ahnung?
Einer eine Ahnung?
Hi Ville,
mit der drug shortage habe ich heute früh mir auch schon angeschaut.
Für SPPI super.
Langsam beschäftige ich mich mehr mit Zevalin. Das Medikament ist von der Wirksamkeit ja sehr gut. Ich verstehe nur nicht, warum so wenig davon Gebrauch gemacht wird????
Als Patient würde ich mich nach Belesen zu einer Behandlung mit Zevalin entscheiden. Auch wenn ich dafür die Praxis oder Krankenhaus wechseln müsste.
Das selbe eigentlich auch in Europa. Die Umsätze sind ja noch eher verhalten.
Fast alle Studien durchweg sehr positiv. Oder sehe ich was falsch???
mit der drug shortage habe ich heute früh mir auch schon angeschaut.
Für SPPI super.
Langsam beschäftige ich mich mehr mit Zevalin. Das Medikament ist von der Wirksamkeit ja sehr gut. Ich verstehe nur nicht, warum so wenig davon Gebrauch gemacht wird????
Als Patient würde ich mich nach Belesen zu einer Behandlung mit Zevalin entscheiden. Auch wenn ich dafür die Praxis oder Krankenhaus wechseln müsste.
Das selbe eigentlich auch in Europa. Die Umsätze sind ja noch eher verhalten.
Fast alle Studien durchweg sehr positiv. Oder sehe ich was falsch???
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