Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2164)

[Magnetfeldfredy]

Blöder Trump:


Novavax gets U.S. defense funding for its COVID-19 vaccine
[Reuters]
Reuters•June 5, 2020

June 4 (Reuters) - Novavax Inc said on Thursday the U.S. Department of Defense (DoD) will give the late-stage biotech company up to $60 million to fund the manufacturing of its experimental COVID-19 vaccine. The U.S.-based company said the deal includes the delivery of 10 million doses of its COVID-19 vaccine - NVX-CoV2373 - to the DoD this year.

The announcement of Novavax's vaccine trial came last month as drugmakers pause clinical trials on drugs for other ailments to focus on COVID-19, the illness caused by the novel coronavirus that has resulted in more than 386,379 deaths globally.

The Maryland-based company joined the race to test coronavirus vaccine candidates on humans and said it was targeting the production of over a billion doses of its vaccine candidate next year.

Preliminary data from its first participants on safety and indicators of an immune response from the trial is expected next month.

Vaccines are seen by world leaders as the only real way to restart their stalled economies after months of sweeping shutdowns. (Reporting by Sanjana Shivdas in Bengaluru, Editing by Sherry Jacob-Phillips)

[Magnetfeldfredy]

Why Didn't Novavax Make Trump's Top 5 COVID-19 Vaccine List?
Novavax is well ahead in clinical testing than two of the White House's COVID-19 vaccine finalists.
Keith Speights
Keith Speights
(TMFFishBiz)
Jun 4, 2020 at 8:23AM
Author Bio

No company has developed a COVID-19 vaccine that's been proven to be safe and effective yet. But several appear to be getting a big boost for their efforts from Uncle Sam.

The New York Times reported on Wednesday that the Trump administration has selected five finalists among the companies developing COVID-19 vaccine candidates. Each of these drugmakers will receive federal money plus assistance in their clinical studies and manufacturing efforts.

There's a reasonable case to be made for the U.S. government to help the companies with the most promising COVID-19 vaccine candidates. But I think the reported list raised a big question: Why wasn't Novavax (NASDAQ:NVAX) in the top five?
President Trump at a podium

Image source: WhiteHouse.gov.
White House favorites

Which drugmakers did make the Trump administration's list of finalists? To no one's surprise, Moderna (NASDAQ:MRNA) was in the group. The biotech's COVID-19 vaccine candidate, mRNA-1273, is already in a phase 2 clinical study. Moderna reported encouraging initial results from its phase 1 study of the vaccine last month.

Another obvious contender is the partnership between AstraZeneca (NYSE:AZN) and the University of Oxford. Like Moderna, the AstraZeneca-Oxford team is currently evaluating COVID-19 vaccine candidate AZD1222 in a phase 2 clinical study.

It also makes sense to me that Pfizer (NYSE:PFE) made the cut. Pfizer is working with German biotech BioNTech (NASDAQ:BNTX) to develop messenger RNA COVID-19 vaccine BNT162. The vaccine is in phase 1 clinical trials in the U.S. and Germany.

Two companies that haven't advanced COVID-19 vaccine candidates to clinical testing yet were also included in the White House favorites. Johnson & Johnson (NYSE:JNJ) selected a candidate in March and plans to begin early stage clinical testing in September. Merck (NYSE:MRK) only recently jumped into the COVID-19 vaccine race, announcing on May 26 that it will acquire Themis, a small company that's developing a COVID-19 vaccine, and partner with nonprofit organization IAVI to develop another COVID-19 vaccine.
Two COVID-19 vaccine bottles standing with two toppled over

Image source: Getty Images.
The argument for Novavax

I think there's a strong case to be made that Novavax deserved to be on the Trump administration's list of finalists. Importantly, the biotech is ahead of both J&J and Merck. Novavax began its phase 1/2 clinical trial of COVID-19 vaccine candidate NVX‑CoV2373 late last month.

It seems likely that Novavax will advance NVX-CoV2373 into phase 2 testing before J&J and Merck crank up phase 1 clinical trials of their respective COVID-19 vaccine candidates. That's a pretty big head start that on the surface appears to have been overlooked by the White House.

What's more, Novavax's COVID-19 vaccine candidate is clearly promising. Last month, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded its biggest grant to date for a COVID-19 vaccine, committing to provide up to $388 million in funding to Novavax for its COVID-19 vaccine efforts.

CEPI's endorsement is a big deal. The organization was founded by the Bill and Melinda Gates Foundation, U.K.-based research charity the Wellcome Trust, the World Economic Forum, and the governments of Norway and India. It has also received financial support from the governments of Australia, Belgium, Canada, Denmark, Ethiopia, Germany, Japan, Mexico, Norway, and the U.K.

In addition, Novavax should be in a good position to scale up the production of its vaccine thanks to the CEPI funding. The biotech announced on May 27 that it's acquiring Praha Vaccines in a deal that will enable it to produce over 1 billion doses per year of its vaccine beginning in 2021.

Sure, Novavax is still a clinical-stage biotech. But so is Moderna. And unlike Moderna, Novavax has already reported successful phase 3 results for another vaccine based on its nanoparticle technology -- flu vaccine NanoFlu.
Will it matter?

Some might argue that politics played a role in the companies selected by the White House. Three of the companies making the cut were invited to meet with President Trump in March. U.K.-based AstraZeneca and Merck were the two exceptions. All of them but Moderna are big pharmaceutical companies. And Moderna has been joined at the hip with the National Institutes of Health since early this year.

It's likely that we'll never know for sure why Novavax didn't make the Trump administration's list of finalists and Merck, a late-comer to the COVID-19 vaccine scene, did. But will it really matter over the long run? Probably not.

Novavax's CEPI funding should enable the company to advance NVX-CoV2373 through late-stage clinical studies, assuming all goes well with earlier clinical trials. In the end, the COVID-19 vaccines that prove to be the safest and most effective in clinical testing will be the real winners. And those winners may or may not be the ones that the White House handpicked.

[Magnetfeldfredy]

Wahrscheinlich stört Ihn, dass Novavax in Tschechien die Fabrik zur Herstellung des Impfstoffes gekauft hat, Amerika first wurde von Novavax dadurch missachtet.....

Ich halte, Trump soll seine Chlortabletten fressen und Desifektionsmittel saufen bis ihn der Teufel holt, viel fehlt nicht mehr............

[suedama]

Antwort auf Beitrag Nr.: 63.888.746 von check2020 am 03.06.20 19:48:21

na der muss es ja wissen...

[check2020]

Trump hat die grade gestrichen.

Die Trump-Administration hat fünf Corona-Impfstoffkandidaten ausgewählt, welche die größte Wahrscheinlichkeit haben zur Marktreife zu kommen. Bei den entsprechenden Unternehmen handelt es sich um Moderna, AstraZeneca (zusammen mit der Oxford-Universität), Johnson & Johnson, Merck und Pfizer. / Quelle: Guidants News https://news.guidants.com

[mfierke]

+++ Eilmeldung: Alles neu! Komplette Neubewertung nach Ad-hoc-Meldung am Dienstag erwartet… +++ Anzeige Startseite > Nachrichten > Pressemitteilungen > Nachricht Novavax wählt AGC Biologics zur Herstellung von Matrix-M Adjuvans für neuen COVID-19-Impfstoff Nachrichtenquelle: PR Newswire (dt.) | 03.06.2020, 13:00 | 121 | 0 | 0 AGC Biologics kooperiert mit Novavax bei der Herstellung der NVX-CoV2373-Komponente SEATTLE, 3. Juni 2020 /PRNewswire/ -- AGC Biologics, ein weltweit führender biopharmazeutischer Vertragshersteller und -entwickler (Contract Development and Manufacturing Organization, CDMO), hat eine Partnerschaft mit Novavax, Inc. (NASDAQ: (NASDAQ: NVAX) bekannt gegeben, einem Late-Stage-Biotechnologieunternehmen mit Schwerpunkt auf der Entwicklung von Impfstoffen der nächsten Generation gegen schwere Infektionskrankheiten, bei der groß angelegten GMP-Produktion einer kritischen Komponente des Coronavirus-Impfstoffkandidaten NVX-CoV2373 von Novavax. AGC Biologics wird Matrix-M, die Adjuvans-Komponente des Impfstoffs, herstellen, um die Immunantwort zu verstärken und ein hohes Niveau an neutralisierenden Antikörpern zu stimulieren. NVX-CoV2373 ist ein stabiles Präfusionsprotein, das mit der proprietären Nanopartikeltechnologie von Novavax hergestellt wird. AGC Biologics wird die Prozessentwicklung für die Scale-up-Produktion von Matrix-M optimieren, um die Kapazität von Novavax zur Bereitstellung von Dosen in den Jahren 2020 und 2021 deutlich zu erhöhen. AGC Biologics logo (PRNewsfoto/CMC Biologics) Anzeige Die ganze Welt. Kostet aber nicht die Welt. Xtrackers Core-ETFs sind eine Palette physisch replizierender ETFs mit niedrigen jährlichen Pauschalgebühren, die Ihnen Zugang zu wichtigsten Aktien- und Anleihenmärkten bieten. Sie können den Kern Ihres Portfolios bilden oder als kosteneffiziente Bausteine eines Multi-Asset-Portfolios dienen. Mehr erfahren powered by finative "Wir arbeiten zügig daran, diese wichtige Impfstoffkomponente zügig an Novavax zu liefern", sagt Patricio Massera, CEO von AGC Biologics. "Die Dringlichkeit, einen Impfstoff zur Bekämpfung von COVID-19 herzustellen, könnte nicht größer sein." "Die Mission von AGC Biologics besteht darin, Seite an Seite mit unseren Partnern zusammenzuarbeiten, um lebensrettende und lebensverlängernde Produkte herzustellen", sagt Mark Womack, CBO von AGC Biologics. "Die Partnerschaft mit Novavax bei der Herstellung dieser Impfstoffkomponente ist eine einzigartige Gelegenheit, einen entscheidenden Beitrag zu leisten." "Wir waren beeindruckt vom Niveau der Zusammenarbeit und dem Engagement von AGC Biologics", sagt Timothy J. Hahn, SVP, Process Technology bei Novavax. "Das Unternehmen ist ein wichtiger strategischer Partner bei der Erweiterung unserer Lieferkette von Adjuvans für NVX-CoV2373 und für andere Impfstoffe, die bei Novavax entwickelt werden, einschließlich unseres rekombinanten Impfstoffs gegen saisonale Grippe, NanoFlu." Informationen zu Novavax: Novavax, Inc. (Nasdaq:NVAX), ist ein Late-Stage-Biotechnologieunternehmen, das sich weltweit für eine verbesserte Gesundheit durch die Erforschung, Entwicklung und Vermarktung innovativer Impfstoffe zur Vorbeugung schwerer Infektionskrankheiten einsetzt. Novavax hat vor kurzem mit der Entwicklung von NVX-CoV2373 begonnen, seinem Impfstoffkandidaten gegen SARS-CoV-2, das Virus, das COVID-19 verursacht. Die Ergebnisse der klinischen Phase 1-Studie werden für Juli 2020 erwartet. NanoFlu, sein vierwertiger Influenza-Nanopartikel-Impfstoff, erfüllte alle primären Ziele in seiner entscheidenden klinischen Phase-3-Studie an älteren Erwachsenen. Beide Impfstoffkandidaten enthalten das firmeneigene, auf Saponin basierende Matrix-M-Adjuvans von Novavax, um die Immunantwort zu verstärken und hohe Konzentrationen neutralisierender Antikörper zu stimulieren. Novavax ist ein führender Innovator von rekombinanten Impfstoffen; seine firmeneigene rekombinante Technologieplattform kombiniert die Leistungsfähigkeit und das Tempo der Gentechnik zur effizienten Herstellung hoch immunogener Nanopartikel, um den dringenden globalen Gesundheitsbedürfnissen gerecht zu werden. Weitere Informationen finden Sie

Novavax wählt AGC Biologics zur Herstellung von Matrix-M Adjuvans für neuen COVID-19-Impfstoff | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/12591173-novavax-…

[Magnetfeldfredy]

Mein Tenbagger dieses Jahr, könnte sich im Idealfall nochmals verzehnfachen, oder 70 % fallen, Gewinne mitgenommen mit 100 Stück bleib ich drin:

Buy Alert: Novavax Stock Is Heading Higher
Speculators are buying up shares of Novavax, based on a vast market opportunity for its COVID-19 vaccine. But there's even better news that largely mitigates any downside risk.
Taylor Carmichael
Taylor Carmichael
(TMFSaintCroix)
May 31, 2020 at 7:10AM
Author Bio

Novavax (NASDAQ:NVAX) has had a phenomenal run since I bought shares in the fall. Overall my cost basis is $6 per share; right now the stock is trading hands at $48 per share.

What's fascinating, and a little scary, is that the dramatic stock increase has almost nothing to do with my original investment thesis. The reason why I bought Novavax: influenza. Novavax had a strong vaccine candidate in phase 3 trials, and the flu vaccine is a $5 billion market opportunity.

What I didn't know at the time was that COVID-19 would strike, putting much of the world into lockdown mode, and sending some small biotech stocks into the stratosphere. That's why shares have run up so high: Novavax has developed a potential vaccine for COVID-19, and it's starting clinical trials in humans.
A person administers a vaccine

Image Source: Getty Images
Speculation or savvy investment?

When a stock goes up 700% in seven months, you might imagine there are emotions involved. Novavax has jumped so high so fast because COVID-19 has caused a major, almost unthinkable shift in our world. Some experts even say we should stay in lockdown mode until a vaccine is produced and widely distributed.

Well, historically it takes seven years -- or more -- for the U.S. Food and Drug Administration (FDA) to approve a vaccine. Obviously, Americans can't spend seven years hiding away. Because this is an emergency situation, health authorities are rushing COVID-19 vaccines into human trials right now, and are trying to get these drugs to market as soon as possible.

Novavax's vaccine candidate is starting its phase 1 trial in Australia with 130 participants. The company expects to announce trial results in July. That is shockingly fast. Of course, positive results could send the stock skyrocketing (again); bad news might send the stock crashing.

For investors, what's interesting is how quickly this product might hit the market. Novavax is already planning a follow-up trial to begin in August. And the biotech is already getting manufacturing in place for emergency use. The company estimates it will be able to ship 100 million doses of a COVID-19 vaccine by the end of the year, and 1 billion doses by the end of 2021.

Novavax can afford to spend all this money on an unproven vaccine because the Coalition for Epidemic Preparedness Innovations (CEPI) gave the company $388 million to continue to develop it. It's basically free money for Novavax. So that's why Novavax can start setting up a phase 2 trial, and manufacturing facilities, even before the data comes in from the first trial.
Best-case and worst-case scenarios

The best-case scenario is rather amazing. Consider how much economic damage COVID-19 has wrought in our world, which is likely to be in the trillions of dollars. So, yes, a working COVID-19 vaccine would be incredibly valuable. Governments would pay a lot of money to get a vaccine on the market, so economies can reopen and people can get back to work. The market opportunity is sky-high.

In the best-case scenario for investors in Novavax, it brings the first vaccine to market or has the highest success rate in clinical trials -- or both. The company is prepping for 1 billion doses to be shipped during 2021. Obviously, prices would have to be negotiated. But the opportunity is clearly vast -- far bigger than the typical $1 billion blockbuster drug.

Consider too that a COVID-19 vaccine is potentially a much larger market than a COVID-19 drug that treats people who have caught the virus. There are whole societies anxious about COVID-19, and many healthy people who want to be vaccinated. The worldwide market for flu vaccines is $5 billion. Most people are far more frightened by COVID-19 than by the flu. And that fear translates into a sizable market opportunity.

So that's the best case: Novavax is early to market, and it has a superior COVID-19 vaccine. Suppose the company charges $100 for its vaccine and distributes 1 billion doses in 2021 as it said it could. That would bring in at least $100 billion. Right now, Novavax has a market cap of only $3 billion.

As for the worst case, that's easy: The vaccine fails a clinical trial. That happens all the time, to the smartest biotech scientists. And there should be little doubt what could happen to Novavax's stock if its COVID-19 vaccine fails in clinical trials -- it could crash, big time. It might be one of those horrific 70% drops that happen all the time in the biotech universe.
Don't forget the flu drug

On the other hand, Novavax investors have a wonderful safety net. Suppose the worst-case scenario comes to pass, and the company's COVID-19 vaccine is a dismal failure. What that would mean is that CEPI wasted its $388 million -- but Novavax didn't burn any of its own cash pursuing the goal.

Yes, that scenario could crash the stock price, and drive COVID-19 speculators out of the stock. But none of that possible bad news would affect Novavax's data for its flu vaccine, NanoFlu. Nor would it change the likelihood of FDA approval for NanoFlu.

While there's plenty of COVID-19 speculation going on in this stock, what's not speculation is the good news about NanoFlu. This is the drug that beat the pants off multiple flu vaccines from market-leader Sanofi in phase 1, phase 2, and phase 3 clinical trials. NanoFlu is on Fast Track designation to be approved this year, and it's a billion-dollar molecule in its own right.

So that's the argument for buying Novavax shares now, despite the fantastic run-up. If the company has any positive news in its COVID-19 trial, the stock will skyrocket in value (again). And if the COVID-19 vaccine trial fails? The short-term fall in the stock price will be significant. But over the long-term, the stock price will be higher than it is today, because the company's flu vaccine is so valuable.

[hn068]

Antwort auf Beitrag Nr.: 63.827.318 von Magnetfeldfredy am 28.05.20 08:52:11

Lohnt der Einstieg?

Hallo zusammen, lohnt sich der Einstieg noch?

[Magnetfeldfredy]

Novavax Seeks To Make 1 Billion Covid-19 Vaccine Doses; Top Analyst Ramps Up PT To $61
Sharon WrobelSharon Wrobel
May 28, 2020, 8:18 AM

Novavax (NVAX) on Wednesday announced the acquisition of Praha Vaccines to help the late-stage biotech company produce over 1 billion doses of its experimental Covid-19 vaccine candidate starting in 2021.

The U.S. company will buy the manufacturing plant for about $167 million in an all cash transaction. Starting in 2021, the plant is expected to provide an annual capacity of over 1 billion doses of antigen for the company’s vaccine candidate, also known as NVX‑CoV2373. As part of the transaction, about 150 employees with experience in vaccine manufacturing and support will join Novavax.

“Manufacturing capacity is a critical component of our strategy to deliver a vaccine for the COVID-19 pandemic,” said Stanley C. Erck, President and CEO of Novavax. “This acquisition provides the vital assets required to produce more than 1 billion doses per year. We will continue efforts to expand antigen capacity in the U.S. and Asia, and increase production of Matrix-M to match antigen capacity at multiple sites globally.”

NVX‑CoV2373 consists of a stable, prefusion protein antigen made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix‑M adjuvant. On Tuesday, Novavax announced that it is starting human testing in its Phase 1/2 clinical trial of the vaccine candidate and is expecting results in July.

The Praha Vaccines acquisition is supported by a funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI), which will help the company to expand its manufacturing capacity.

As part of the deal, the biotech company will work in collaboration with the Serum Institute of India (SII) to boost production levels at the Bohumil facility by the end of 2020.

Novavax’s stock has jumped 10 times in value since the start of the year and was down 5.6% trading at $45.47 as of Wednesday’s close.

Following the announcement, five-star analyst Mayank Mamtani at B. Riley FBR raised the stock’s price target to $61 from $53, reflecting another 34% upside potential in the shares over the coming year.

Mamtani said that he now expects earlier global market entry of the 2373 vaccine candidate as well as “model additional non-dilutive funding to further accelerate development and commercialization activities.” The analyst maintained a Buy rating on the stock.

“We view this as another encouraging development providing validation to the de-risked nature of NVAX’s vaccine candidate, on the basis of the most extensive/differentiated preclinical data generated to date, and now reviewed closely by global scientific community residing with CEPI, WHO, and SII as well as U.S. agencies such as CDC, NIH-NIAID, and BARDA,” Mamtani wrote in a note to investors.

The rest of Wall Street analysts covering the stock in the past three months join Mamtani in their recommendation to Buy the shares. The Strong Buy consensus is backed up by 5 unanimous Buy ratings. In view of the stock’s fast rally this year, the $49.20 average price target indicates a modest 8% upside potential in the coming 12 months. (See Novavax stock analysis on TipRanks).

[Mr_Value]

Antwort auf Beitrag Nr.: 63.803.540 von DeluxeCourse am 26.05.20 10:03:32

https://finance.yahoo.com/news/novavax-begins-human-testing-…