Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage - Älteste Beiträge zuerst (Seite 122)

[STEV-o]

New Data from Novavax Phase 3 Prepare™ Trial of ResVax™ Presented at 2019 IDSOG Annual Meeting

Data demonstrate significant vaccine efficacy against infant pneumonia through the first year of life

GAITHERSBURG, Md., Aug. 12, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the presentation of new data from the company’s Prepare™ trial, a global Phase 3 clinical trial of ResVax™, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine. Geeta K. Swamy, M.D., Associate Professor of Obstetrics and Gynecology and Vice Dean and Associate Vice Provost for Scientific Integrity at Duke University, made the presentation at the 2019 IDSOG Annual Meeting held in Big Sky, Montana.

Dr. Swamy’s presentation included new observations based on the recently completed analyses of the 1-year safety data, including a 59.6% (95% CI 34.5, 71.7%) reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life. A similar efficacy of approximately 50% (95% CI 31.3, 62.7%) was found for all SAEs with a clinical diagnosis of pneumonia, also extending over a year. When x-ray-confirmed pneumonia SAEs associated with detection of RSV were considered, efficacy was 72.9% (95% CI. 45.7, 86.5%) through 180 days of life, the last time point at which active detection of RSV was carried out.

“Ongoing analysis of the Prepare trial data is teaching us more about how and where the vaccine was most efficacious in reducing RSV infections and its most severe complications,” said Louis F. Fries III, M.D., Chief Medical Officer of Novavax. “Based on the incidence rate for clinical pneumonia SAEs in placebo subjects in the Prepare trial and the vaccine’s efficacy in reducing this rate, ResVax could have a public health impact, in terms of vaccine-preventable disease incidence or number of women needed to vaccinate to prevent one case of infant pneumonia, that is similar or in excess of pneumococcal conjugate vaccines for similar outcomes. Such insights are valuable as we explore potential regulatory and clinical development paths forward to deliver an effective vaccine to address a serious global unmet need.”

Please click here to view a PDF of Dr. Swamy’s presentation along with other scientific presentations.

About ResVax™ and the Prepare Trial

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. In February 2019, Novavax announced top-line data from Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Novavax

Novavax, Inc. (NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection which is the second leading cause of death in children under one year of age worldwide. Novavax is also advancing NanoFlu™, its quadrivalent influenza nanoparticle vaccine, to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
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Gute Studienergebnisse. Kann Novavax irgendwann seinen investoren mal was zurückzahlen? Ich mag noch nicht so recht dran glauben...

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Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu

Novavax, Inc.: Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu Influenza Vaccine in Older Adults
First participants enrolled in pivotal Phase 3 clinical trial of NanoFlu
Top-line clinical data expected in the first quarter of 2020
Phase 3 results expected to support a future BLA and licensure of NanoFlu using the FDA's accelerated approval pathway

[TZ350]

Novavax Reports Third Quarter 2019 Financial Results

http://ir.novavax.com/news-releases/news-release-details/nov…

Drittes Quartal 2019 und nachfolgende operative Höhepunkte

NanoFlu ™ Programm

Novavaxleitete eine entscheidende klinische Phase-3-Studie für NanoFlu, seinen rekombinanten vierwertigen saisonalen Influenza-Impfstoffkandidaten, ein und schloss die Aufnahme von 2.652 gesunden älteren Erwachsenen an 19 klinischen Standorten in den USA ab. Das Hauptziel der randomisierten, vom Beobachter verblindeten, aktiv kontrollierten Studie ist der Nachweis einer nicht minderwertigen Immunogenität, gemessen anhand der HAI-Titer (Hemagglutination Inhibition) der homologen Influenzastämme des Impfstoffs und der Sicherheit im Vergleich zu einem zugelassenen Impfstoff, Fluzone ® Quadrivalent.

Die wichtigsten Ergebnisse dieser klinischen Phase-3-Studie werden für das erste Quartal 2020 erwartet und würden einen nachfolgenden US-amerikanischen Antrag auf Zulassung von Biologika (BLA) und die Zulassung von NanoFlu unter Verwendung der US-amerikanischen Food and Drug Administration (FDA) unterstützen.FDA) beschleunigter Zulassungsweg.

Auf 19. September 2019Es wurde eine Verordnung des Präsidenten erlassen, die die Modernisierung von Influenza-Impfstoffen zugunsten der nationalen Sicherheit und der öffentlichen Gesundheit der USA vorschreibt. Diese Verordnung untermauert den strategischen Wert des NanoFlu-Programms insbesondere deshalb, weil NanoFlu als nicht auf Eiern basierender Impfstoff, der unter Verwendung der rekombinanten Nanopartikel-Technologie formuliert wurde und mit einem sicheren und wirksamen Adjuvans kombiniert ist, alle Merkmale des vom Orden vorgeschriebenen besseren Influenza-Impfstoffs aufweist . Die vollständige Executive Order finden Sie hier .
ResVax ™ -Programm

Das FDA und der Europäische Arzneimittel-Agentur (EMA) haben beide empfohlen Novavax Führen Sie eine zusätzliche klinische Phase-3-Studie durch, um die Wirksamkeit von ResVax zu bestätigen. Novavax befindet sich in ständigen Gesprächen mit beiden globalen Regulierungsbehörden und potenziellen Partnern, um die Möglichkeit zu prüfen, ResVax weltweit auf den Markt zu bringen.

Novavax stellte auf der Jahrestagung der Gesellschaft für Geburtshilfe und Gynäkologie für Infektionskrankheiten (IDSOG) im August und auf der Weltimpfkongress - Europaletzte Woche. Die Präsentationen enthielten neue Beobachtungen auf der Grundlage der kürzlich abgeschlossenen Analysen der 1-Jahres-Sicherheitsdaten, einschließlich einer Verringerung der Häufigkeit schwerwiegender unerwünschter Ereignisse (SAEs), bei denen eine Pneumonie diagnostiziert wurde, um 56,9% (95% CI 34,5, 71,7%), mit Bestätigung durch Röntgenaufnahme der Brust, die sich über das erste Lebensjahr erstreckte.
Ebola ™ -Programm

Das Journal of Infectious Diseasesveröffentlichte ein von Fachleuten geprüftes Manuskript, in dem die positiven Ergebnisse der klinischen Phase-1-Studie von Novavax an gesunden Erwachsenen des Ebola-Virus-Glykoprotein-Impfstoffkandidaten aufgeführt sind. Weitere Details zum Manuskript finden Sie hier .

Gute Beschreibung der aktuellen Unternehmenstätigkeiten. Ich bin gespannt auf das 1. Quartal 2020.

[STEV-o]

Totgesagte leben länger oder das letzte Zucken vor dem Ende? Wundertüte Novavax.

[pickuru]

Gregory Glenn von "Novavax" im Interview vom 23. Januar 2020

https://aktien-boersen.blogspot.com/2020/01/gregory-glenn-vo…

[SpecialSituations]

Co-Diagnostics: Vielleicht auch ganz interessant für alle, die in Coronavirus-Aktien spekulieren.
https://www.wallstreet-online.de/nachricht/12091233-co-diagn…

[SpecialSituations]

Vielleicht auch ganz interessant, für alle die in Coronavirus-Aktien zocken: Co-Diagnostics A2DU6V. Meldung vor 1 oder 2 Tagen, dass Coronavirus-Test entwickelt wurde...

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Shares of Novavax (NASDAQ:NVAX) were up 18.1% as of 10:32 a.m. EST on Wednesday after rising as much as 41% earlier in the day. The big jump came after the biotech announced plans to begin clinical testing by late spring for an experimental vaccine to protect individuals against COVID-19, the disease caused by the novel coronavirus that's causing major health concerns across the world.

[Magnetfeldfredy]

Coronavirus-Impfstoff wird in Tierversuchen angewendet:

Novavax Begins Animal Testing for Coronavirus Vaccine Candidate
Novavax says it's ready to advance its vaccine candidate to Phase I clinical testing in May or June.

Tony Owusu
13 minutes ago

Novavax (NVAX) - Get Report shares jumped Thursday after the company announced that it was beginning animal testing for its potential coronavirus vaccine candidates with plans to use those tests to determine which would be best suited to try on humans.

The company developed the candidates using its proprietary recombinant protein nanoparticle technology platform.

“Our previous experience working with other coronaviruses, including both MERS and SARS, allowed us to mobilize quickly against Covid-19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates,” said CEO Stanley C. Erck.

Novavax touted its “proven track record” of producing rapid innovative vaccines against previous coronaviruses, including Middle East Respiratory Syndrome (MERS) andSevere Acute Respiratory Syndrome (SARS).

“We are now well-positioned to advance the Covid-19 vaccine candidate to Phase I clinical testing in May or June,” Erck said.

Novavax was gaining more than 24% to $11.50 in trading Thursda

[easymueller]

Andere entwickeln Medikamente, Novavax den Impfstoff, Potential sicher noch 100% plus X