Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 103)
neuester Beitrag 25.10.15 15:31:16 von
Neuigkeiten zur Novavax Aktie
einzige Meldungen in letzter Zeit waren über einige Käufe von Mitarbeitern des Managements sowie ein Übergang von Phase II in III.
Und in den Ami-Boards wird heftig diskutiert. In D fast gar kein Handelsvolumen mehr.
in 3 Wochen kontinuierlich von 1,25 auf 1,9 - heute wieder kräftig gestiegen.
Ohne großartige Nachrichten. Ich kann mir dabei nur Insiderwissen vorstellen - schon wegen der Käufe des Managements
Pennt ihr alle?
2 Dollar ...... über 50 % in 3 Wochen. Immer mit etwas überdurchschnittlichem Volumen.
Kommt hier bald die große Nachricht? Habe bisher noch nicht rausgefunden , womit dieser Anstieg zusammenhängt. RSV kann es nicht sein, daß ist in Phase I. Andere Impfstoffe in II bzw. III.
Novavax In Collaboration For New Malaria Vaccine In India
WASHINGTON (dpa-AFX) - Novavax Inc. (NVAX) said Monday it has formed a new collaboration with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology to develop a novel malaria vaccine in India.
Novavax said the collaboration will combine the advanced vaccine technology of Novavax with the malaria vaccine research capabilities of International Centre for Genetic Engineering and Biotechnology, or ICGEB, and vaccine manufacturing capability of CPL Biologicals, or CPLB.
The project is being funded by India's Department of Biotechnology Vaccine Grand Challenge Program.
Malaria remains a major public health problem in many regions of the tropical world. Forty percent of the world's population lives in malaria endemic regions of Africa, Asia and Central and South America.
About 210 million cases of malaria are reported each year, leading to around 650,000 deaths, primarily in children less than five years of age.
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© 2012 AFX News
Read more: http://www.benzinga.com/news/12/07/2753457/novavax-and-path-announce-partnership-on-rsv-vaccine#ixzz20z2EvpPZ
Novavax, Inc. (Nasdaq: NVAX) announced a clinical development partnership with PATH to develop its RSV (respiratory syncytial virus) vaccine to protect infants through maternal immunization in low-resource countries. Novavax has been awarded approximately $2 million by PATH for initial funding under the partnership to partially support a Phase II dose-ranging clinical trial in women of childbearing age planned for the second half of this year. Following this initial study, PATH may elect to continue to partner with Novavax and provide support for the external clinical development costs through commercialization for this indication.
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(c) 2012 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted in: News, Contracts, FDA
Read more: http://www.benzinga.com/news/12/07/2753457/novavax-and-path-announce-partnership-on-rsv-vaccine#ixzz20z28yyJJ
Novavax, PATH sign RSV vaccine clinical development partnership
Novavax and PATH have signed a clinical development partnership to develop the respiratory syncytial virus (RSV) vaccine.
According to the collaboration, Novavax's Phase II trial scheduled for second half of 2012 will be designed to evaluate the immune response to different doses of the vaccine candidate in women of childbearing age.
PATH will fund approximately $2m on a non-dilutive basis for Novavax's external clinical development costs of the trial.
The recombinant RSV fusion (F) protein vaccine candidate might then be advanced by immunising pregnant women so as to transmit high levels of maternal RSV antibodies to offspring through the placenta before birth thereby providing protection against infection in the early infancy period.
Novavax president and CEO Stanley Erck said the partnership with PATH complements the company's strategy to develop this RSV vaccine for multiple indications in affected patient populations, in all markets throughout the world with multiple partners.
"We estimate that the world-wide market for an RSV vaccine could exceed $5 billion," Erck added.
PATH may then elect to continue to partner with Novavax and provide support for the external clinical development costs through commercialisation for the indication.
Novavax will retain global rights to commercialise the product and considers making the product affordable and available in low-resource countries.
Novavax Says Primary Endpoints Achieved In Phase II Seasonal Influenza Trial
WASHINGTON (dpa-AFX) - Novavax Inc. (NVAX) reported positive top-line results from the company's Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle or VLP vaccine candidate. The study's primary objectives of demonstrating safety and immunogenicity of three ascending dose levels of the quadrivalent influenza vaccine were achieved.
The company said that the VLP vaccine candidate demonstrated immunogenicity against all four viral strains based on hemagglutination inhibition assay (HAI) responses at day 21, was also well-tolerated with no vaccine-related serious adverse events observed and reactogenicity was considered acceptable.
A secondary endpoint of the study was to evaluate the potential of the VLP vaccine to fulfill the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research or CBER criteria for accelerated approval.
In adult populations under 65 years of age, these criteria are based on demonstration of seroconversion rates (the proportion of subjects with a four-fold rise in HAI titer or attaining a titer of >=1:40 from a negative baseline) and seroprotection rates (the proportion of subjects with HAI titers >=1:40 post-vaccination) that are >=40% and >=70%, respectively, at the lower 95% confidence bound.
The company noted that the VLP vaccine candidate exceeded protocol design expectations by fulfilling the FDA seroprotection criterion at the lower 95% confidence bound for all four viral strains included. The VLP vaccine candidate also demonstrated the potential to fulfill the FDA seroconversion criterion by demonstrating >=40% seroconversion against three of four viral strains. The fourth virus, B/Brisbane/60/08, despite fulfilling the seroprotection criterion, failed to meet the seroconversion criterion.
The company also announced completion of enrollment of its two Phase I clinical trials to evaluate the safety and immunogenicity of its monovalent VLP A/H5N1 pandemic influenza vaccine comparing two different adjuvanted vaccine candidates with an unadjuvanted vaccine candidate. Top line data from these trials are expected in the fourth quarter of this year.
The company said it is developing both seasonal and pandemic vaccine candidates under a multi-million dollar contract with BARDA, who has been an active partner in planning and evaluating the development of these products.
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© 2012 AFX News