Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage - Älteste Beiträge zuerst (Seite 110)

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Novavax Initiates Phase 2 Safety and Immunogenicity Trial to Evaluate Annual Re-Dosing of the RSV F Vaccine in Older Adults
GAITHERSBURG, Md. , Oct. 22, 2015

http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…

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U.S. FDA Grants Fast Track Designation to Novavax’ RSV F Vaccine for Older Adults
http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…

ich hoffe, dass wir hier den Boden gesehen haben

[DasTier666]

Better Buy: Novavax, Inc. vs. Pfizer Inc.
Small vaccine developer or big pharma? How Novavax and Pfizer stack up.

Every day it seems like viruses are making the news. Savvy investors looking to make a profit (and one that they can feel good about!) might be taking note of this global healthcare trend and looking to invest in vaccine makers working to combat these viruses. Two companies on polar ends of the spectrum in the vaccine world are Novavax (NASDAQ:NVAX) and Pfizer (NYSE:PFE). The former is currently valued at around $1.5 billion and doesn't have a product on the market yet. The latter boasts a market cap of over $200 billion, and lays claim to the world's top-selling vaccine in recent years, the pneumococcal vaccine Prevnar.
But does Pfizer's size and existing product lineup make it the better pick for investors? Or does Novavax's future potential give it an advantage? Here's how the two stocks stack up against each other.

The case for Novavax

Novavax's management is unashamedly bullish about the prospects for its lead candidate, a vaccine for respiratory syncytial virus F-protein nanoparticle (RSV F). They project potential peak revenue of $6 billion to $8 billion for the vaccine. That's considerably higher than the $1.86 billion that Pfizer made on Prevnar last year.

Could Novavax's RSV F vaccine really become that successful? Maybe. Novavax hopes to address two markets with the vaccine in the not-too-distant future: infants up to six months old and older adults. The company has phase 3 studies in progress for both target populations.

Phase 2 results for Novavax's vaccine administered to older adults showed 44% prevention of all types of RSV, with 46% prevention of RSV with symptoms of lower respiratory tract infection. The vaccine also prevented 64% of older patients from developing serious symptoms of lower respiratory tract infections. Those results were comparable to Prevnar's efficacy.

Novavax's phase 2 testing for protection of infants via maternal immunization also met with success. Pregnant women in their third trimester were given the RSV F vaccine, and gave birth to infants that were found to have 110% to 120% of their mothers' antibody levels, suggesting protection from RSV for at least 90 days.

So what does all of this mean for Novavax's stock potential? Even if the company's peak sales projections are overly optimistic, the sheer market size of around 65 million older Americans and 4 million infants in the U.S. should translate to significant revenue -- if, that is, all goes well with phase 3 testing and the regulatory approval process.

There haven't been any major safety concerns thus far. Efficacy for both older adults and infants appears promising. While the possibility exists that Novavax could encounter problems somewhere along the way, the company's chances of gaining regulatory approval seem reasonably good at this point. If phase 3 results for Novavax's RSV F vaccine are positive, particularly the study focusing on older adults, the stock would probably soar by triple-digit percentages.

The case for Pfizer

It's highly unlikely that Pfizer's stock will see the kind of surge that could potentially be in the cards for Novavax. On the other hand, the big drugmaker doesn't have nearly the level of risk that Novavax has, either.

Think of Pfizer's play as being the same as the tortoise in its race with the hare -- slow and steady. Pfizer's main problem, though, is that it hasn't been all that steady in recent years. Revenue has fallen over the last few years, in large part because of loss of patent exclusivity for key drugs.

Pfizer's situation should improve, however. The company projects that 2016 revenue and earnings will increase respectably compared to 2015. Pfizer got off to a great start in the first quarter, with year-over-year revenue growth of 20%.

Prevnar continues to perform very well, but Pfizer has other winners as well. Sales of new breast cancer drug Ibrance are booming. Smoking cessation aid Chantix/Champix and rheumatoid arthritis drug Xeljanz are also showing impressive sales growth.

Pfizer is also buying growth, or at least trying to do so. The big pharmaceutical company recently announced that it planned to acquire Anacor Pharmaceuticals (NASDAQ:ANAC) for $5.2 billion. Anacor's big draw is anti-inflammatory drug crisaborole. Phase 3 testing of the drug went well, and the FDA expects to make an approval decision by January 7, 2017.

Whether or not Pfizer gets the growth it expects from the Anacor deal depends on how well crisaborole does, assuming the drug gets a green light from regulators. Pfizer thinks that crisaborole will generate peak annual sales of $2 billion. If the drug hits this mark (and sustains that sales level for a while), the Anacor deal will look pretty smart in hindsight.

Meanwhile, investors can enjoy Pfizer's juicy 3.5% dividend yield. The company's dividend payout ratio of over 93% is high, but Pfizer has enough cash to keep the dividend payments flowing while its earnings situation improves.

Better buy

So which is the better stock for investors right now? It really depends on how risk-averse you are. If you shudder at the thought of wild stock price swings, Novavax probably isn't a good choice for you. If you're comfortable taking on risk, though, the smaller company is worth a look.

I think that Novavax is likely to ultimately win approval for its RSV F vaccine in addressing both of its primary target populations. (The company also has a phase 1 clinical trial in progress for children between six months and five years old, but it's way too early to know how that study will turn out.) If Novavax is successful, this stock will pay off in a huge way for investors who buy at current price levels. While the tortoise won in the old fable, I'll go with the hare in this race.


http://www.fool.com/investing/2016/05/30/better-buy-novavax-…

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The Biggest Threat to Novavax Stock
The biopharmaceutical still has to jump some regulatory hurdles to get its RSV F vaccine approved, but the biggest danger to the company's success with it might not be the most obvious one.
Keith Speights (TMFFishBiz) Apr 9, 2016 at 6:42AM

Any stock that loses over half of its market cap in an eight-month stretch might be viewed as a wee bit risky. Novavax (NASDAQ:NVAX) was flying high last summer. But then came the biotech slump, driven at least in part by political backlash against excessively high drug prices. Novavax also released phase 2 results for its respiratory syncytial virus (RSV) vaccine that, while positive on the surface, raised questions about whether the vaccine, when administered to pregnant women, effectively transfers maternal immunization to infants as it is intended to do.

This double-whammy clobbered shares. Novavax stock is now more than 50% below its August 2015 levels. Better days could be ahead for the biotech, but there's at least one major threat looming on the horizon.

Stating the obvious
The most visible risk for Novavax is that its bid to secure regulatory approval for the RSV F vaccine might fall flat. How big of a risk is this? There's certainly a possibility that the drug could run into problems, but my guess is that its chances for approval are pretty good.

The company has two pivotal phase 3 clinical trials in progress for the RSV F vaccine. One is focused on protecting older adults against RSV, while the other trial focuses on the protection of infants from RSV via maternal immunization. Both late-stage trials come on the heels of generally successful phase 2 clinical studies.

There weren't any yellow flags with Novavax's phase 2 trial on older adults. Results showed statistically significant efficacy in prevention of RSV disease among the 1,600 patients participating in the study. The safety profile of patients taking Novavax's experimental vaccine was found to be nearly identical to that of patients on placebo.

Results from the phase 2 study on pregnant women and newborns also were positive. The response to the vaccine in the women participating in the trial was similar to the immune response observed in non-pregnant women. There also appeared to be a robust transfer of antibodies from the mothers to their unborn children. Some concerns remain, however.

Novavax didn't actually demonstrate that infants were protected from RSV by the vaccine -- only that the antibodies from immunized mothers were passed to them. Also, because pregnant women aren't given the vaccine until the third trimester, the RSV F vaccine wouldn't help infants born prematurely prior to that point.

A potentially greater threat
While there is always a danger that a drug won't make it through the regulatory approval process, there is another risk to the biopharmaceutical here that might be even greater: It could face troubles launching the vaccine successfully. Novavax intends to sell RSV F in the U.S. all by itself, but plans to find a partner to help market the vaccine outside of the U.S. Each effort comes with its own set of risks.

Assuming the RSV F vaccine wins FDA approval, it would be Novavax's first product on the market. The potential for missteps with a first-time commercialization effort is substantial. Novavax appears to be in good shape on at least one front. The company reported $230.7 million in cash, cash equivalents and investments at the end of 2015 and raised another $276 million in January by issuing convertible senior notes.

Finding the right partner for the international market could also be tricky. Novavax CEO Stanley Erck has said that the company wants a partner (or partners) that "have the existing infrastructure and experience to deliver on the promise" of RSV F. He also stated that Novavax plans "serious discussions with the top players in the field, or the top wannabe RSV players in the field".

AstraZeneca (NYSE:AZN) stands out as the current top player in the RSV treatment field. The big pharmaceutical company's drug Synagis isn't a vaccine, but is used to protect high-risk children from RSV. There could be one strike against AstraZeneca as a potential partner, though. The company has its own drug targeting prevention of RSV disease in older adults in phase 2 clinical testing.

Of course, Erck also mentioned "wannabe RSV players." GlaxoSmithKline (NYSE:GSK) is a possible contender in that category. It has plenty of vaccines on the market currently, but none to prevent RSV. Novavax desires a partner with a solid infrastructure and experience to make an international launch of RSV F successful, and Glaxo certainly fits the bill. On the other hand, Glaxo, too, has a couple of RSV vaccines in its pipeline -- one in phase 1 testing and another in phase 2.

There's at least one other "wannabe" that could be interested in RSV F -- Merck (NYSE:MRK). Like Glaxo, Merck has a laundry list of vaccines, but unlike AstraZeneca and Glaxo, Merck doesn't have any RSV drugs in its pipeline. Teaming up with Novavax could make sense if it's interested in competing in the RSV space.

Looking ahead
Novavax intends to move forward quickly on discussions with potential partners. However, it's quite possible that the interested parties will want to wait for results from the two phase 3 studies.

My take is that those studies will likely go well. I think the vaccine has a good shot at winning regulatory approval. I also expect Novavax will line up an established partner to help market RSV F outside of the U.S. The huge drop Novavax's share price has already experienced takes some of the risk (although certainly not all of it) off the table for investors. My prediction is that this biotech will emerge as a big winner in 2016.

http://www.fool.com/investing/general/2016/04/09/the-biggest…

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Novavax to Expand Operations in Montgomery County, Plans to Add up to 850 New Jobs
June 8, 2016

Growing Company Developing Promising Vaccines for RSV, Influenza, and Ebola

ANNAPOLIS, MD – Novavax, a clinical stage vaccine company that works to deliver novel products to prevent a broad range of infectious diseases, has announced plans to expand its presence in Montgomery County. The company, which has its headquarters in Gaithersburg, is planning to build out its research, development, and clinical trial support operations. As part of the expansion, Novavax plans to retain its current 400 full-time employees and add up to 850 new jobs to accommodate its growing pipeline of vaccine candidates.

The announcement coincides with the 2016 BIO International Convention in San Francisco, where the state is being represented by nearly 70 Maryland-based companies, agencies, and organizations.

Novavax has initiated more than 20 clinical trials targeting infectious diseases, including respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). In May 2016, Novavax signed a lease for approximately 150,000 square feet of facility space located at 1201 Clopper Road in Gaithersburg. Novavax selected Maryland and the Clopper Road location for its expansion through a competitive process and made a concerted decision to grow within the local area. The new space will support laboratory and manufacturing activities. In addition to its Gaithersburg headquarters, the company also has locations in Rockville and Uppsala, Sweden.

“The primary focus of our administration is to help foster greater economic opportunity for our citizens and create jobs,” said Governor Hogan. “This expansion, along with the addition of 850 new jobs, is a win for hardworking Marylanders and our state as a whole. Innovative companies like Novavax – that choose to grow their business right here in Maryland – underscore our administration’s commitment to strengthening our economy.”

“Supporting the expansion of companies like Novavax helps reinforce Maryland’s leadership in the life sciences, and positions the state as an ideal place where companies can develop innovative treatments, diagnostics and cures,” said Maryland Commerce Secretary Mike Gill. “We are proud to support the expansion of one of Maryland’s home-grown companies and are pleased to see that Novavax is quickly becoming a significant player in the field of vaccine development.”

“Montgomery County is proud to have Novavax in our county, which adds another highly important stable and growing bio health asset to a hub of regional and national firms,” said Montgomery County Executive Isiah Leggett. “Novavax’s research helps save lives and blazes new trails in the life sciences industry.”

“We thank Novavax for choosing to stay and grow in Gaithersburg,” said Mayor Jud Ashman. “Our city has unique attributes that support emerging biotechnology. Chief among those traits is our talented workforce, represented by the many current employees of Novavax. We extend a warm welcome to the hundreds of people who will fill the company’s new jobs here.”

To assist with project costs related to the expansion, the Maryland Department of Commerce has approved a total of $5 million in conditional loans for the three phases of the project through the Maryland Economic Development Assistance Authority and Fund (MEDAAF) program. The loans are based on the company’s job creation and capital expenditure as part of the expansion. Montgomery County has approved a conditional grant of up to $2.5 million and the company is eligible for the county’s New Jobs Tax Credit. In addition, the City of Gaithersburg has approved up to a $50,000 grant from its Economic Development Toolbox program. The company is also eligible for a number of state tax credits and programs.

http://governor.maryland.gov/2016/06/08/novavax-to-expand-op…

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Der nächste Fool-Artikel

Here's Why Novavax's Stock Could Double
The Street is super bullish on Novavax's stock right now. Here's why.

http://www.fool.com/investing/2016/06/14/heres-why-novavaxs-…

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3 Biotech-Aktien, die Milliardäre kaufen – und ich auch: Novavax, Agile Therapeutics und Flexion Therapeutics
Nachrichtenquelle: The Motley Fool
| 16.06.2016, 16:00

Milliardenschwere Investoren haben schon bewiesen, dass sie in guten wie in schlechten Zeiten Geld verdienen können und obwohl man niemals jemandem blind folgen sollte, kann es eine gute Idee sein, die Käufe und Verkäufe der weltbesten und klügsten Investoren zu verfolgen. Das kann einem nämlich gute Investmentideen geben. Unter diesem Gesichtspunkt habe ich die vierteljährlichen Berichte meiner liebsten Milliardäre an die Börsenaufsicht untersucht und diese drei interessanten Aktien für mein Portfolio entdeckt:

Novavax

George Soros ist vielleicht der einflussreichste Hedgefondsmanager der Geschichte und obwohl sich die Aktien in seinem Portfolio häufig ändern, habe ich diesen äußerst interessanten Kauf von 30.000 Aktien von Novavax (WKN:898527) gefunden.

Soros managt Milliarden von Dollar, daher ist das eine sehr kleine Position für ihn und der Kauf könnte andeuten, dass er schon mal das Terrain sondiert, bevor die Daten aus Phase 3 eines Impfstoffes gegen RSV oder Respiratorischer Syncytial-Virus herauskommen. Bei RSV handelt es sich um einen häufigen Grund, warum kleine Kinder und ältere Mitmenschen ins Krankenhaus eingeliefert werden.

Aktuell gibt es kein zugelassenes Mittel, um RSV zu vermeiden. In den Versuchen wurden über 1.600 ältere Leute getestet und RSV-F von Novavax ist bisher das erste Mittel, das bei diesen Patienten Wirkung zeigt.

Wenn die Ergebnisse der endgültigen Tests diese Ergebnisse bestätigen können (die Daten werden im dritten Quartal erwartet), dann könnte dieses Impfmittel schon 2017 erhältlich sein. Da RSV in den USA jährlich zu 132.000 Krankenhausaufenthalten von Kleinkindern und 180.000 alten Leuten führt, könnte diese Impfung zu einem Bestseller werden.

Es ist unklar, wie viel dieser Impfstoff Novavax einbringen könnte, aber das Management hat in der Vergangenheit gemeint, das Spitzenpotenzial dieses Medikaments könnte bei über 6 Milliarden US-Dollar pro Jahr liegen. Das ist zwar eine nicht nachvollziehbare Vorhersage, aber wenn RVS-F bei den Senioren funktioniert und zusätzliche Tests zeigen, dass es auch bei schwangeren Frauen benutzt werden kann, um RSV bei Babies zu verhindern, dann sind Umsätze in Milliardenhöhe möglich, Immerhin schätzt das Unternehmen, dass bis 2020 111 Millionen Senioren allein in den USA dafür in Frage kämen. Wenn das Unternehmen diese Patienten für sich gewinnen kann, dann könnte die Marktkapitalisierung von 1,7 Milliarden US-Dollar zu niedrig sein.

http://www.wallstreet-online.de/nachricht/8689769-3-biotech-…

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der Form halber hier die Halbjahreszahlen

Novavax Reports Second Quarter 2016 Financial Results
http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…

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starkes Volumen heute und nur noch 3 Wochen Zeit für die PIII Ergebnisse

Novavax: High Probability Of A Huge Gain Within Weeks
http://seekingalpha.com/article/4005021-novavax-high-probabi…

Current Job Listings 79 Total Job(s)
https://novavax.applicantpro.com/jobs/

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Die letzten Insider-Transaktionen zeugen von recht wenig Optimismus.
http://us.finance.qa1p.global.media.yahoo.com/q/it?s=NVAX+In…

Mein Einsatz ist bereits raus und der Rest bleibt.