Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2158)

[Magnetfeldfredy]

Novavax (NVAX) PT Raised to $24 at Ladenburg Thalmann, Following Report Of NanoFlu Achieving All Primary Endpoints In Phase 3 Clinical Trial
March 24, 2020 2:14 PM EDT Send to a Friend
Ladenburg Thalmann analyst Michael Higgins ...

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[Joe833]

Antwort auf Beitrag Nr.: 63.118.561 von suedama am 24.03.20 19:43:40

Das stimmt, wenn da corona stehen würde wär der Kurs jetzt 3 stellig

[suedama]

Antwort auf Beitrag Nr.: 63.116.500 von Joe833 am 24.03.20 17:26:39

klar aber eigentlich zu wenig...zur Zeit hat irgendwie keiner Interesse an
einem Grippemittel...schon crass. Das wird wohl erst was, wenn die ihr
Mittelchen produzieren und verkaufen...wenn da nicht influenza sodern
corona stehen würde...wär das Ding durch die Decke gegangen...ohne Worte!

[Joe833]

Ist doch heute $ über 40% gestiegen. Leute verkaufen halt jetzt wieder wie blöd

[hn068]

Antwort auf Beitrag Nr.: 63.112.915 von Joe833 am 24.03.20 13:19:23

Warum passiert nichts?

Die Ergebnisse, die das letzte Mal zum Absturz der Aktie führten sind heute positiv und der Aktienkurs steigt nicht sonderlich. Warum?

[Joe833]

Antwort auf Beitrag Nr.: 63.111.676 von quater111 am 24.03.20 11:41:55

Zitat von quater111: Die Frage ist wie hoch und was bedeutet die Pressemeldung

Musst halt lesen

Es gab positive Ergebnisse.

positive Ergebnisse der klinischen Phase 3-Zulassungsstudie von NanoFlu

[quater111]

Antwort auf Beitrag Nr.: 63.111.520 von Joe833 am 24.03.20 11:32:21

Die Frage ist wie hoch und was bedeutet die Pressemeldung

[Joe833]

Schießt richtig nach oben 👍

[Magnetfeldfredy]

Sieg, geil:

Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial
[GlobeNewswire]
GlobeNewswire•March 24, 2020

Trial also achieves statistical significance in key secondary endpoints
Novavax to submit a U.S. BLA under FDA’s accelerated approval pathway
Company to host investor conference call today at 8:30 a.m. EDT

GAITHERSBURG, Md., March 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

NanoFlu Phase 3 Primary Objectives

The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents.

NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine.

NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).

“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”

NanoFlu Phase 3 Secondary Objectives

The trial’s key secondary endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents, which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses.

NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine.

24%-66% higher GMT responses; and
11.4-20.4 higher SCR percentage points.


NanoFlu also demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent for four tested drifted H3N2 strains not included in the vaccine but circulating this year.

34%-41% higher GMT responses; and
14.1-16.8 higher SCR percentage points

“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” said Gregory Glenn, M.D., President of Research and Development of Novavax. “NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift. We extend our sincere appreciation to those who volunteered for this important study and to our clinical partners who worked so quickly and diligently on this trial.”

Webcast Conference Call

Novavax will host a webcast/conference call today at 8:30 a.m. ET. The webcast can be accessed via a link on the home page of the Novavax website (novavax.com) or through the “Investor Info”/“Events” tab on the Novavax website. Listeners who wish to ask questions or don’t have internet access can dial-in to the conference call at [phone] (domestic) or [phone] (international) and use passcode 4498251.

A replay of the webcast will be available on the Novavax website until June 24, 2020 and a replay of the conference call only will be available starting at 11:30 a.m. ET on March 24, 2020 until 11:30 a.m. ET on March 31, 2020. To access the conference call replay, dial [phone] (domestic) or [phone] (international) and use passcode 4498251.

About Phase 3 Clinical Trial

The trial enrolled 2,652 healthy older adults across 19 U.S. clinical sites. Trial participants received either NanoFlu or the comparator, both of which were formulated with the four influenza strains recommended for the 2019-2020 Northern hemisphere influenza season. Participants will be followed for approximately one year after injection, with primary immunogenicity analyses of the Day 28 sera samples.

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 amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. The qNIV vaccine antigens were derived from A/Brisbane 02/2018 H1N1, A/Kansas 14/2017 H3N2, B/Maryland 15/2016 and B/Phuket 3073/2013. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.

About Novavax

Novavax, Inc. (NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met primary and secondary endpoints in its pivotal Phase 3 clinical trial. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. 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, 2019, 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
[e-mail]
240-268-2022

Westwicke
John Woolford
[e-mail]
443-213-0506

Media
Brandzone/KOGS Communication
Edna Kaplan
[e-mail]
617-974-8659

Contact:

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The Zacks Analyst Blog Highlights: Moderna, Novavax and Regeneron Pharmaceuticals
[Zacks]
Zacks Equity Research
,Zacks•March 19, 2020
The Zacks Analyst Blog Highlights: Moderna, Novavax and Regeneron Pharmaceuticals

For Immediate Release

Chicago, IL – March 19, 2020 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna, Inc. MRNA, Novavax, Inc. NVAX and Regeneron Pharmaceuticals, Inc. REGN.

Here are highlights from Wednesday’s Analyst Blog:

Hopes of a COVID-19 Vaccine Buoy Drug Makers: 3 Solid Buys

Moderna, Inc.’s shares have been treading higher after the company dosed a patient with a vaccine against the novel coronavirus in the Phase 1 study being conducted by the National Institutes of Health. What’ more, another 48 adults are expected to participate in the study that includes two vaccine dozes within a gap of 28 days.

Moderna’s chief medical officer, Tal Zaks said that “this study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity.”

The company already drew attention after it received funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a messenger RNA (mRNA) vaccine to fight the novel coronavirus. Moderna has collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) to develop the experimental mRNA vaccine.

It’s worth pointing out that unlike DNA-based treatments, Moderna focuses on developing mRNA treatments, which should help in treating the virus better. DNA-based treatments generally require the nucleus of the cell but mRNA can be found across the cell which makes it easily accessible.

Moderna in the meantime has confirmed that the company is preparing for a Phase 2 trial of the coronavirus vaccine. The company’s manufacturing unit is also aiming to improve production capacity so that it can produce “millions of doses,” provided the vaccine is safe and effective. Moderna, in fact, wants the vaccine to have a high safety level, which is well above the 0.63-4.24% death rate, according to the Centers for Disease Control.

Moderna is now at the top of the list of companies struggling to manufacture vaccines against COVID-19, the disease that has claimed lives across the globe, weighed on corporate earnings, disrupted supply chains and dealt a blow to economic growth.

And thanks to its leadership position, President Trump invited Moderna to the big pharma meet in the White House a couple of weeks ago. Notably, Moderna was the smallest in terms of market cap among the other drug makers that were invited in the meeting.

Last but not the least, Moderna has been pretty impressive. After getting to know the virus’ genetic composition, it took the company less than two months to develop the vaccine. Moderna currently flaunts a Zacks Rank #2 (Buy). The Zacks Consensus Estimate for its current-year earnings has moved up 6.2% over the past 60 days.

What’s more, the company’s expected earnings growth rate for the current and next quarter is 7.5% and 9.8%, respectively. You can see the complete list of today’s Zacks #1 Rank stocks here.

Coming back to those racing to develop a vaccine against COVID-19, Novavax, Inc.andRegeneron Pharmaceuticals, Inc. are among the front runners.Obviously, shares of vaccine manufacturers have gained sharply on concerns over the virus. Novavax, a late-stage biotechnology company, saw its shares soar more than 100% so far this year.

The Zacks Rank #2 company is primarily manufacturing two late-stage vaccines for the flu and various other infectious diseases. The Zacks Consensus Estimate for its current-year earnings has moved up 20.4% over the past 60 days. The company’s expected earnings growth rate for the current and next quarter is 72.7% and 67.5%, respectively.

Based on Ebola knowledge, Regeneron Pharmaceuticals is making a COVID-19 vaccine. The company’s initiatives in the same line have helped its shares increase leaps and bounds this year, especially when compared to the mere 2.5% it brought in over the last 12 months.

Regeneron key drugs — Eylea and Dupixent – have been performing well as well. Label expansion into additional indications should further increase the commercial potential of the drugs.

Regeneron currently possesses a Zacks Rank #1 (Strong Buy). The Zacks Consensus Estimate for its current-year earnings has moved 8.4% north over the past 60 days. The company’s expected earnings growth rate for the current and next quarter is 41.4% and 21.3%, respectively (read more: Coronavirus Fears Holding You Back? 3 Smart Ways to Invest).

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Media Contact

Zacks Investment Research

800-767-3771 ext. 9339

[e-mail]

https://www.zacks.com

Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.


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14 viewing

Tony

5 days ago
A lot of people listened to Zack In The Box in the past ..... and lost a lot of money !
JR
5 days ago
Zacks pumps MRNA and the stock stops trading (as it hits limit down). Nice call Zacks *smirk*
LarryM
5 days ago
People should be talking about AIM. They have an approved antiviral that works and is being tested by Japan Ministry of Health. Results due any day now. Might be key to protecting people who fall ill at the Olympics.
6
Top Ranked Momentum Stocks to Buy for March 19th
[Zacks]
Zacks Equity Research
,Zacks•March 19, 2020

Here are four stocks with buy rank and strong momentum characteristics for investors to consider today, March 19th:

The Clorox Company (CLX): This manufacturer of consumer and professional products has a Zacks Rank #2 (Buy) and witnessed the Zacks Consensus Estimate for its current year earnings increasing 2% over the last 60 days.
The Clorox Company Price and Consensus
The Clorox Company Price and Consensus
The Clorox Company Price and Consensus

The Clorox Company price-consensus-chart | The Clorox Company Quote

Clorox’s shares gained 20.1% over the last one month above the S&P 500’s decrease of 28.9%. The company possesses a Momentum Score of A.
The Clorox Company Price
The Clorox Company Price
The Clorox Company Price

The Clorox Company price | The Clorox Company Quote

Campbell Soup Company (CPB): This manufacturer of food and beverage products has a Zacks Rank #2 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 2.8% over the last 60 days.
Campbell Soup Company Price and Consensus
Campbell Soup Company Price and Consensus
Campbell Soup Company Price and Consensus

Campbell Soup Company price-consensus-chart | Campbell Soup Company Quote

Campbell Soup’s shares gained 11.7% over the last one month. The company possesses a Momentum Score of A.
Campbell Soup Company Price
Campbell Soup Company Price
Campbell Soup Company Price

Campbell Soup Company price | Campbell Soup Company Quote

Vaxart, Inc. (VXRT): This clinical-stage company has a Zacks Rank #2 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 86.4% over the last 60 days.
VAXART, INC. Price and Consensus
VAXART, INC. Price and Consensus
VAXART, INC. Price and Consensus

VAXART, INC. price-consensus-chart | VAXART, INC. Quote

Vaxart’s shares gained 75.5% over the last one month. The company possesses a Momentum Score of B.
VAXART, INC. Price
VAXART, INC. Price
VAXART, INC. Price

VAXART, INC. price | VAXART, INC. Quote

Novavax, Inc. (NVAX): This late-stage biotechnology company has a Zacks Rank #2 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 24.4% over the last 60 days.
Novavax, Inc. Price and Consensus
Novavax, Inc. Price and Consensus
Novavax, Inc. Price and Consensus

Novavax, Inc. price-consensus-chart | Novavax, Inc. Quote

Novavax’s shares gained 18.9% over the last one month. The company possesses a Momentum Score of B.
Novavax, Inc. Price
Novavax, Inc. Price
Novavax, Inc. Price

Novavax, Inc. price | Novavax, Inc. Quote

See the full list of top ranked stocks here

Learn more about the Momentum score and how it is calculated here.

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VAXART, INC. (VXRT) : Free Stock Analysis Report

Novavax, Inc. (NVAX) : Free Stock Analysis Report

Campbell Soup Company (CPB) : Free Stock Analysis Report

The Clorox Company (CLX) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research
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Symbol Last Price Change % Change
NVAX
Novavax, Inc.
10.76 +0.41 +3.96%
AMRN
Amarin Corporation plc
10.55 -0.09 -0.85%

[hn068]

Weiß man denn schon konkret, wann die Phase 3 Studie veröffentlicht wird?