Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2166)
eröffnet am 25.04.09 09:22:26 von
neuester Beitrag 04.05.24 00:07:47 von
neuester Beitrag 04.05.24 00:07:47 von
Beiträge: 22.842
ID: 1.149.910
ID: 1.149.910
Aufrufe heute: 74
Gesamt: 1.233.183
Gesamt: 1.233.183
Aktive User: 0
ISIN: US6700024010 · WKN: A2PKMZ · Symbol: NVV1
4,5660
EUR
+3,88 %
+0,1705 EUR
Letzter Kurs 03.05.24 Tradegate
Neuigkeiten
01.05.24 · Felix Haupt Anzeige |
16.04.24 · Sharedeals |
18.03.24 · wallstreetONLINE Redaktion |
Werte aus der Branche Biotechnologie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 38,27 | +28,16 | |
| 8,0780 | +27,90 | |
| 10,155 | +21,04 | |
| 8,1400 | +20,41 | |
| 3,6100 | +17,51 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,6700 | -26,58 | |
| 2,1300 | -34,41 | |
| 3,1600 | -38,64 | |
| 1,7000 | -49,40 | |
| 125,00 | -95,83 |
Beitrag zu dieser Diskussion schreiben
Feedback
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)
Contact:
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)
Contact:
Bin auch dabei, ist wie Roulette, schwarz oder rot, bei Erfolg Multibagger bei Mißerfolg US$1, yes we hope!
Veröffentlichung von Resultaten im 1. Quartal 2019
https://www.nasdaq.com/article/why-novavax-is-up-60-in-2018-…https://seekingalpha.com/article/4225860-novavax-break-actio…
Sorry -- So sollte es sein.
Veröffentlichung von Resultaten im 1. Quartal 2019
Thread: Kein Titel für Thread 4225860[/u][/https://www.nasdaq.com/article/why-novavax-is-up-60-in-2018-…[/u]
Positive Nachrichten
https://finance.yahoo.com/news/why-transocean-novavax-steelc… Trading Spotlight
Antwort auf Beitrag Nr.: 57.165.084 von DasTier666 am 01.03.18 22:40:43Wird sehr sicher nun stetig aufwärts gehen, evtl sogar gesünder als die krassen Sprünge.
Why Novavax Stock Spiked Today
Motley Fool March 1, 2018
What happened
Shares of the clinical-stage vaccine maker Novavax (NASDAQ: NVAX) rose by as much as 27.6% today on over three times the average daily trading volume. Although the biotech's stock has cooled off in the interim, Novavax's shares are still up by a healthy 7% as of 2:44 p.m. EST.
The catalyst? Before the opening bell, the company reported positive top-line results for its experimental flu vaccine, NanoFlu, in a combined phase 1/2 trial in older adults. The headline item is that NanoFlu reportedly outperformed Sanofi's market-leading Fluzone High-Dose by generating higher hemagglutination inhibition (HAI) antibody responses against both the H1N1 and H3N2 influenza strains.
So what
After an unusually severe flu season in which Sanofi and other vaccine makers were largely unable to adequately control the outbreak, the multibillion dollar flu vaccine market is arguably ripe for the picking by a newcomer like Novavax's NanoFlu.
Now what
According to its press release, Novavax said it plans on initiating another midstage trial for NanoFlu by the third quarter of this year. That's the good news.
The bad news is that company is going to have to raise a significant sum of capital soon in order to carry out another trial for NanoFlu and advance its other clinical candidates at the same time. Novavax, after all, only had around $172 million in cash remaining at the end of the last quarter, but an annual burn rate of about $168 million. With additional trials in the works, Novavax's burn rate probably won't taper off anytime soon.
All told, Novavax's initial NanoFlu data are certainly intriguing from a value proposition standpoint. But the company arguably needs to address its long-term financial needs. Until then, this small-cap biotech stock will continue to be an exceptionally volatile equity.
https://finance.yahoo.com/news/why-novavax-stock-spiked-toda…
Motley Fool March 1, 2018
What happened
Shares of the clinical-stage vaccine maker Novavax (NASDAQ: NVAX) rose by as much as 27.6% today on over three times the average daily trading volume. Although the biotech's stock has cooled off in the interim, Novavax's shares are still up by a healthy 7% as of 2:44 p.m. EST.
The catalyst? Before the opening bell, the company reported positive top-line results for its experimental flu vaccine, NanoFlu, in a combined phase 1/2 trial in older adults. The headline item is that NanoFlu reportedly outperformed Sanofi's market-leading Fluzone High-Dose by generating higher hemagglutination inhibition (HAI) antibody responses against both the H1N1 and H3N2 influenza strains.
So what
After an unusually severe flu season in which Sanofi and other vaccine makers were largely unable to adequately control the outbreak, the multibillion dollar flu vaccine market is arguably ripe for the picking by a newcomer like Novavax's NanoFlu.
Now what
According to its press release, Novavax said it plans on initiating another midstage trial for NanoFlu by the third quarter of this year. That's the good news.
The bad news is that company is going to have to raise a significant sum of capital soon in order to carry out another trial for NanoFlu and advance its other clinical candidates at the same time. Novavax, after all, only had around $172 million in cash remaining at the end of the last quarter, but an annual burn rate of about $168 million. With additional trials in the works, Novavax's burn rate probably won't taper off anytime soon.
All told, Novavax's initial NanoFlu data are certainly intriguing from a value proposition standpoint. But the company arguably needs to address its long-term financial needs. Until then, this small-cap biotech stock will continue to be an exceptionally volatile equity.
https://finance.yahoo.com/news/why-novavax-stock-spiked-toda…
Antwort auf Beitrag Nr.: 57.159.375 von Ginelli83 am 01.03.18 15:13:492,95$, ich hoffe du gewinnst
Antwort auf Beitrag Nr.: 57.159.333 von DasTier666 am 01.03.18 15:10:31Schließen bei 3,10$, mein Tipp 💪🏻
Durchsuchen
16.04.24 · Sharedeals · Novavax |
18.03.24 · wallstreetONLINE Redaktion · Guess? |
03.03.24 · wO Chartvergleich · Allianz |
29.02.24 · Sharedeals · Novavax |
28.02.24 · BörsenNEWS.de · Novavax |
28.02.24 · wallstreetONLINE Redaktion · Novavax |
25.02.24 · wO Chartvergleich · ENCAVIS |
23.02.24 · PR Newswire (dt.) · Novavax |
22.02.24 · wallstreetONLINE Redaktion · Novavax |
21.02.24 · wO Chartvergleich · Dow Jones |