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Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 120)



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Bin auch dabei, ist wie Roulette, schwarz oder rot, bei Erfolg Multibagger bei Mißerfolg US$1, yes we hope!
Phase 2 mit Nanoflu erfogreich bestanden geht nun in Phase 3, wahrscheinlich mit accelerate approval:

Novavax Announces Positive Phase 2 NanoFlu Results in Older Adults
GlobeNewswire•January 3, 2019

Sets the Stage for Phase 3 Clinical Trial in 2019

Phase 2 clinical trial confirmed Phase 1/2 results, again demonstrating improved immune responses over Fluzone® High-Dose
End-of-Phase 2 meeting with the FDA expected in the first half of 2019
Pivotal Phase 3 clinical trial expected to initiate in 2019

GAITHERSBURG, Md., Jan. 03, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) today announced top-line results of its Phase 2 clinical trial of NanoFlu™. The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax’ Matrix-M™ adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.

Key findings of the Phase 2 clinical trial:

All formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine.
Matrix-M adjuvant resulted in significant enhancement of immune responses when compared to the unadjuvanted formulation.
NanoFlu is a differentiated flu vaccine, as evidenced by significantly superior hemagglutination inhibition (HAI) antibody responses against wild-type A(H3N2) viruses, including drifted strains, when compared to Fluzone High-Dose, the leading flu vaccine in older adults.
45% increase against vaccine-homologous virus, A/Singapore (p<0.001)
22% increase against a historic drifted virus, A/Switzerland (p=0.014)
42% increase against a forward drifted virus, A/Wisconsin (p<0.001)
NanoFlu formulation identified for the Phase 3 clinical trial and commercialization.

“The superior immunogenicity against wild-type H3N2 viruses holds promise that NanoFlu will more effectively address the mismatch between circulating viruses and the strains included in most commercial vaccines due to genetic drift and vaccine virus egg adaptation,” said Gregory Glenn, M.D., President of Research and Development of Novavax. “Older adults experienced the brunt of the serious health consequences of this mismatch, with H3N2 driving the majority of influenza hospitalizations and death during 2017-2018, the worst flu season in four decades. Over the past several years, influenza vaccine effectiveness has been suboptimal in this population, and there is broad agreement that better vaccines are needed. These confirmatory data from the second clinical trial of NanoFlu further justify continued rapid development of an improved vaccine.”

As Novavax previously announced, the U.S. Food and Drug Administration (FDA) acknowledged that the accelerated approval pathway may be available for NanoFlu, which could allow for licensure of NanoFlu in a shorter timeframe. Novavax will again meet with the FDA in the first half of 2019 to discuss the Phase 2 clinical trial data, the proposed Phase 3 trial design, and the use of accelerated approval for licensure.

“The Phase 2 clinical trial results with NanoFlu demonstrate the potential impact our vaccine can make in preventing serious disease caused by influenza in older adults, a high-risk population that has proven difficult to protect in recent years,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Our goal remains to advance to the market an improved vaccine that addresses the serious global public health threat that exists for older adults, and ultimately to make NanoFlu available to all populations.”

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans, with symptoms ranging from mild to life-threatening, or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2021.2

About NanoFlu™ and Matrix-M™

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its Sf9 insect cell baculovirus system. NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which is potent, well-tolerated and stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the HAI antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

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.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2017 and the Quarterly Report on Form 10-Q for the period ended September 30, 2018 as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Trahan
Senior Manager, Investor & Public Relations
ir@novavax.com
240-268-2000

Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Sam Brown
Andrea Cohen
andreacohen@sambrown.com
917-209-7163

1 Resolution of the World Health Assembly (2003) WHA56.19.28

2 Influenza Vaccines Forecasts. Datamonitor (2013)


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Antwort auf Beitrag Nr.: 59.555.699 von Magnetfeldfredy am 04.01.19 09:59:15Endlich mal ne positive Nachricht von NVAX. Ich hatte zwar mit einem höheren Kurs gerechnet, aber 6% bis jetzt sind auch OK. Nun müssen nur noch die Phase III Daten der RSV Studie positiv ausfallen.
https://www.bizjournals.com/washington/news/2019/01/04/novav…

mit Google übersetzt ;)

Novavax Inc. beginnt das Jahr 2019 und meldet positive Phase-2-Ergebnisse für seinen Grippeimpfstoffkandidaten Donnerstag in einem für die Gaithersburger Biotech-Industrie voraussichtlich kritischen Jahr.

Die klinische Studie für NanoFlu, bei der die Immunreaktionen älterer Erwachsener auf zwei auf dem Markt befindliche Grippeimpfstoffe verglichen wurden, zeigte, dass die Formulierungen gut verträglich waren - und 50 Prozent wirksamer als der Marktführer Fluzone High-Dose.

Die Ergebnisse ließen die Aktien von Novavax (NASDAQ: NVAX) am Donnerstag und Freitag um mehr als 6 Prozent steigen. Die Aktie notierte am Freitagnachmittag bei etwa 2,15 USD.

Novavax wird sich im zweiten Quartal mit der FDA treffen, um die NanoFlu-Ergebnisse der Phase 2 und das Design der Phase 3-Studie zu diskutieren. Die Agentur hat bereits gesagt, dass der Weg zur beschleunigten Zulassung möglich ist. Die Phase-3-NanoFlu-Studie könnte in diesem Szenario im dritten Quartal 2019 beginnen, und die Ergebnisse könnten im ersten Quartal 2020 vorliegen , sagte Dr. Gregory Glenn , Präsident der Forschungs- und Entwicklungsabteilung von Novavax.

"Sie sehen, dass es einen Menschenschrei für die Art von Impfstoff gibt, den wir machen", sagte er mir.

NanoFlu ist vielversprechend, weil es anders hergestellt wird als herkömmliche Grippeimpfstoffe, von denen viele in einem "antiquierten" und "umständlichen, teuren, unordentlichen Prozess" entwickelt werden, sagte Edward Tenthoff , Geschäftsführer und leitender Biotech-Analyst bei Piper Jaffray & Co.

"Novavax 'Ansatz ist viel sauberer", sagte er. „Es handelt sich um einen rekombinanten Proteinimpfstoff, der das Antigen buchstäblich synthetisiert. Es ist schneller, es ist billiger. “

Novavaxs RSV-Impfstoffkandidat ResVax - zur Vorbeugung der Atemwegserkrankung bei Neugeborenen durch mütterliche Impfung - ist auf dem Weg, die Ergebnisse der Phase 3 im weiteren Verlauf des Quartals zu liefern. Es ist der einzige RSV-Impfstoff in klinischen Studien im fortgeschrittenen Stadium.

Es ist ein entscheidender Moment für Novavax, das 2016 eine Phase-3-Studie für einen anderen RSV-Kandidaten für ältere Personen durchgefallen war . Und während RSV und Grippe völlig unterschiedliche Märkte und Produkte repräsentieren, „haben wir aus der Erfahrung älterer Impfstoffe viel gelernt“, sagte Glenn. Zu diesen Lehren: Die Adjuvantien, die eine höhere Antikörperreaktion bewirken, sind in der älteren Bevölkerung wichtig. Daher hat Novavax die Technologie auf NanoFlu angewendet.
Der Showdown beginnt:

Investigational RSV Maternal Immunization Could Revolutionize Treatment
JAN 21, 2019 | KEVIN KUNZMANN
The state of maternal immunization is much different now than from when Gregory M. Glenn, MD, first started in health care. It was widely studied and assessed, but still not as practiced in pregnant women.

Now, Glenn, president of Research & Development for Novavax Inc., and his teams of investigators are at the cusp of revolutionary development for maternal vaccines.

The Maryland-based clinical-stage vaccine company intends to share data in the following weeks on its first clinical trial of an investigative respiratory syncytial virus (RSV) vaccine in third-trimester pregnant women. Its findings and eventual successive studies could alter the scope of care for RSV, the most common cause of bronchiolitis and pneumonia in children younger than 1 year in the US.

The trial—which has been ongoing for 4 years and has assessed the potential vaccine in about 3000 treatment-eligible pregnant subjects in that time—has been carried out by teams comprising RSV, vaccination, and maternity-care specialists across 11 countries. “This is an incredible number of people working on a trial,” Glenn told MD Magazine®. “And because they’re on the front line, they are extremely excited at the prospect of having a vaccine for infants.”

Glenn also noted at least 1 other party’s particular interest in the development of an RSV vaccine: the Bill & Melinda Gates Foundation granted $89 million to the outside costs of the trial in 2015.
Global Implications
If the phase 3 results indicate the Novavax vaccine was capable of reaching its primary endpoint—reduced incidence of medically significant RSV lower respiratory tract infection (LRTI) with either hypoxemia or tachypnea in infants through 90 days of life—and key secondary endpoints, it could eventually become the first US Food and Drug Administration (FDA) approved RSV vaccine indicated for infants.

Investigator Pedro A. Piedra, MD, a professor in the Department of Molecular Virology and Microbiology, and Pediatrics at Baylor College of Medicine, explained to MD Magazine® that the international focus of the study was for good purpose—RSV is recognized by the World Health Organization (WHO) as causing significant morbidity and mortality risk in children 5 years and younger, with no vaccines available.

“Children most at risk are under 6 months of age,” Piedra said. “But to target them with vaccination becomes very difficult. We often think about giving children vaccines at 2 to 6 months. This leaves the concept of maternal immunization.”

Investigators randomized pregnant women aged 18 to 40 years 2:1 to receive vaccine or placebo, respectively. Though no data pertaining to the vaccine’s efficacy is yet available, investigators have received some indication of its safety and tolerability. Glenn noted that an FDA-approved safety data monitoring board was granted unblinded observation of the frequently-updated trial results.

Since starting the study, the Novavax team received no notification of unsafe events that would require them to suspend or prematurely end the study. Piedra emphasized this observation spanned the entire four-year duration, as that is how long it took the investigators to fulfill patient participation standards.

“One always has to be cautious, but I’m cautiously optimistic that the vaccine will meet its primary outcome,” Piedra said.

Piedra noted alternative therapies for pediatric RSV are limited. Monoclonal antibodies with extended half-life has shown capability to protect infants from maternal birth through early childhood, yet carry a greater market price and risk of safety than a vaccine would. There’s also something to be said for a vaccine’s potential as a widespread, long-term influencer in pediatric pulmonary health.

“It’s important to understand RSV is a global pathogen,” Piedra explained. “The majority of deaths occur in low-resourced countries, but it’s the number 1 cause of hospitalization in children under the age of 1 in US. It’s also associated with increased asthma risk within a patient’s first decade of life.”
Long Wait, Long-Term Benefits
It would be interesting, he suggested, to see the both the acute and long-term impacts of a vaccination down the road.

Glenn recalled a time when the majority of infants and young children in the intensive care unit could have been practically split by 2 specialties: gastroenterology, and pulmonary. The former is no longer a driver of pediatric disease; the development of a rotavirus vaccine resolved many issues in the field. He projects a similar outcome with a capable RSV vaccine.

“From a biotech standpoint, it’s got to be one of the biggest pieces of news this year, just because of the impact,” Glenn said.

Beyond a November 2017 futility analysis allowed by the FDA, Glenn, Piedra and the investigators are not aware to any impeding outcome data. But there’s optimism, due to previous results, interim discussion, and possibly the scale of the trial itself.

“It’s been a long wait,” Glenn said.

The article "Novavax Nears Maternal Immunization Results for RSV Vaccine," was originally published on MDMag.com.
Wainwright sees almost three-bagger in Novavax; shares up 8% premarket
Jan. 28, 2019 7:43 AM ET|By: Douglas W. House, SA News Editor

Uber-bull H.C. Wainwright initiates coverage on Novavax (NASDAQ:NVAX) with a Buy rating and $6 :D:eek:(174% upside) price target. Analyst Vernon Bernardino believes peak sales of its RSV vaccine could top $2B by 2025, assuming an FDA filing in early 2020.

Shares are up 8% premarket on modest volume.

Source: Bloomberg

See all stocks on the move »
Aktienkurs um 63% gefallen
https://seekingalpha.com/news/3438417-novavax-rsv-vaccine-fl…

Google Übersetzung:

Novavax RSV-Impfstoff greift im Spätstadium der Studie an; Aktien sanken um 63%

28. Februar 2019 7:29 AM ET | Über: Novavax, Inc. (NVAX) | Von: Douglas W. House, SA Nachrichtenredakteur



• Novavax (NASDAQ: NVAX) ist bereit für einen signifikanten Abwärtstrend nach den Ergebnissen einer klinischen Phase-3-Studie "Prepare", bei der ResVax, ein rekombinanter rekombinanter rekombinanter Nanopartikel-Impfstoff des respiratorischen respiratorischen Synzytialvirus (RSV), getestet wird Säuglinge von der mütterlichen Immunisierung gegen die RSV-Krankheit.

• Die Studie konnte sich nicht ausreichend von Placebo trennen, gemessen an der Inzidenz von RSV-Infektionen der unteren Atemwege (LRTI) über einen Zeitraum von 90 Tagen, dem primären Endpunkt.

• In der Behandlungsgruppe betrug die Inzidenz von medizinisch signifikantem RSV-LRTI 39% (Placebo-Inzidenz nicht angegeben).

• Zusätzliche Daten werden zur Präsentation bei einer zukünftigen medizinischen Konferenz vorgelegt.

• Das Management wird heute morgen um 8.00 Uhr (ET) eine Telefonkonferenz abhalten, um die Ergebnisse zu besprechen.

• Die Anteile sind um 63% vor dem Markt gefallen.
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