Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2167)
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Antwort auf Beitrag Nr.: 56.679.896 von gerdass am 10.01.18 21:56:25sieht gut aus
Novavax up 44% on positive expectations from late-stage study of RSV vaccine in newborns via maternal immunization
Novavax (NVAX +44.4%) is up on almost 5x higher volume on the heels of its announcement of encouraging developments in a Phase 3 clinical trial assessing the effectiveness of its RSV F vaccine in newborns by immunizing mothers. The information was part of a corporate presentation delivered at JPM18.
The primary endpoint of the study is the incidence of RSV lower respiratory tract infection. In order to inform on further investment in the program, the company conducted an informational analysis based on a target efficacy threshold of at least 40% at day 90. The analysis showed that the observed efficacy should be 45 - 100%. It also concluded that the medically significant secondary endpoints (e.g., hospitalizations, more severe RSV infections) would likely exceed the threshold for vaccine efficacy.
A Data Safety Monitoring Board statistician communicated to the company that the vaccine successfully met these criteria based in an analysis of unblinded data (company remains blinded).
Enrollment efforts have been ramped up in order to accelerate the timing of the interim data readout, expected by Q4 2018/Q1 2019. If positive, a U.S. marketing application could be filed by late 2019. If approved, it will be the only game in town. Management sees global peak sales of at least $1.5B ($750M in U.S.).
https://seekingalpha.com/news/3322167-novavax-44-percent-pos…
Novavax (NVAX +44.4%) is up on almost 5x higher volume on the heels of its announcement of encouraging developments in a Phase 3 clinical trial assessing the effectiveness of its RSV F vaccine in newborns by immunizing mothers. The information was part of a corporate presentation delivered at JPM18.
The primary endpoint of the study is the incidence of RSV lower respiratory tract infection. In order to inform on further investment in the program, the company conducted an informational analysis based on a target efficacy threshold of at least 40% at day 90. The analysis showed that the observed efficacy should be 45 - 100%. It also concluded that the medically significant secondary endpoints (e.g., hospitalizations, more severe RSV infections) would likely exceed the threshold for vaccine efficacy.
A Data Safety Monitoring Board statistician communicated to the company that the vaccine successfully met these criteria based in an analysis of unblinded data (company remains blinded).
Enrollment efforts have been ramped up in order to accelerate the timing of the interim data readout, expected by Q4 2018/Q1 2019. If positive, a U.S. marketing application could be filed by late 2019. If approved, it will be the only game in town. Management sees global peak sales of at least $1.5B ($750M in U.S.).
https://seekingalpha.com/news/3322167-novavax-44-percent-pos…
Hammer Volumen heute
hier der Link zur Januar Präsentation
http://novavax.com/download/files/presentation/36th_Annual_J…
Sollten dann noch die NanoFLu Daten in Februar überzeugen könnte es noch weiter gehen
http://ir.novavax.com/news-releases/news-release-details/nov…
hier der Link zur Januar Präsentation
http://novavax.com/download/files/presentation/36th_Annual_J…
Sollten dann noch die NanoFLu Daten in Februar überzeugen könnte es noch weiter gehen
http://ir.novavax.com/news-releases/news-release-details/nov…
Antwort auf Beitrag Nr.: 55.388.442 von Cyberhexe am 24.07.17 23:40:05Sehe ich auch so. Nun noch eine neue PII, da wird's eng mit der Kohle.
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Antwort auf Beitrag Nr.: 55.384.653 von DasTier666 am 24.07.17 15:16:29
...da soll dem einfältigen Investor eine Mogelpackung verkauft werden: "positive topline data” jedoch nicht zu Wirksamkeit, lediglich Info zu Nebenwirkungen und Immunogenicity bei dieser gescheiterten ph2-Studie. Wer macht wann das Licht aus?
Zitat von DasTier666: Novavax to Host an RSV F Vaccine Update Conference Call and Webcast on July 24, 2017 at 4:30 PM
Preliminary webcast agenda:
1. Announce topline data from the Phase 2 safety and immunogenicity trial in Older Adults
2. Provide additional findings from prior Phase 2 and Phase 3 clinical trials in Older Adults
3. Update on the Prepare™ trial for Infants via Maternal Immunization
http://ir.novavax.com/news-releases/news-release-details/nov…
Na mal schauen, was die Jungs zu berichten haben. Vorbörse sieht gut aus, zur Zeit 7% im Grünen.
...da soll dem einfältigen Investor eine Mogelpackung verkauft werden: "positive topline data” jedoch nicht zu Wirksamkeit, lediglich Info zu Nebenwirkungen und Immunogenicity bei dieser gescheiterten ph2-Studie. Wer macht wann das Licht aus?
nur so am Rande
Genocea Reports Positive Top-Line 12-Month Phase 2b Data for GEN-003 in Genital Herpes
Jul 24, 2017
...
About GEN-003
Inducing a T cell response against genital herpes is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class investigational T cell-directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea's ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease and identifies antigen targets that drive effective T cell responses. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M™ adjuvant (licensed from Novavax, Inc. (NASDAQ:NVAX)). For more information about GEN-003, please visit the GEN-003 section of the Genocea website.
...
http://ir.genocea.com/releasedetail.cfm?releaseid=1034082
Genocea Reports Positive Top-Line 12-Month Phase 2b Data for GEN-003 in Genital Herpes
Jul 24, 2017
...
About GEN-003
Inducing a T cell response against genital herpes is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class investigational T cell-directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea's ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease and identifies antigen targets that drive effective T cell responses. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M™ adjuvant (licensed from Novavax, Inc. (NASDAQ:NVAX)). For more information about GEN-003, please visit the GEN-003 section of the Genocea website.
...
http://ir.genocea.com/releasedetail.cfm?releaseid=1034082
Novavax to Host an RSV F Vaccine Update Conference Call and Webcast on July 24, 2017 at 4:30 PM
Preliminary webcast agenda:
1. Announce topline data from the Phase 2 safety and immunogenicity trial in Older Adults
2. Provide additional findings from prior Phase 2 and Phase 3 clinical trials in Older Adults
3. Update on the Prepare™ trial for Infants via Maternal Immunization
http://ir.novavax.com/news-releases/news-release-details/nov…
Na mal schauen, was die Jungs zu berichten haben. Vorbörse sieht gut aus, zur Zeit 7% im Grünen.
Preliminary webcast agenda:
1. Announce topline data from the Phase 2 safety and immunogenicity trial in Older Adults
2. Provide additional findings from prior Phase 2 and Phase 3 clinical trials in Older Adults
3. Update on the Prepare™ trial for Infants via Maternal Immunization
http://ir.novavax.com/news-releases/news-release-details/nov…
Na mal schauen, was die Jungs zu berichten haben. Vorbörse sieht gut aus, zur Zeit 7% im Grünen.
starker Kursgewinn
NASDAQ und Lang & Schwarz machen heute bei Novavax weiter große Schritte nach oben. Die Rückkehr - die Seitwärtsbewegung ist beendet
Die neuen Zahlen sprechen für sich und die bevorstehende Veröffentlichung lässt bei Insidern die Vermutung aufkommen, endlich sind die Testphasen erfolgreich verlaufen! Warum sollte Novavax denn auch sonst schon seit Tagen Gerüche streuen, dass die Herstellung der Impfstoffe direkt nach der Veröffentlichung beginnen könnte?! 
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