Nvax nanoflu

The U. Through Operation Warp Speed OWSthe government has offered vaccine developers billions of dollars in an effort to bring a vaccine to market by January.

Now, word on the street is that a launch may come even sooner. The Centers for Disease Control and Prevention CDC recently advised states to prepare for a possible vaccine rollout as soon as late October, according to news reports.

That means a vaccine would be available before the presidential election on Nov. Considering the timeline, let's take a look at whether it's a good idea to buy shares of Novavax before that day comes. Does Novavax stand a chance at being first to market with its potential coronavirus vaccine?

It's unlikely, but not impossible. Novavax's vaccine candidate is in phase 2 of clinical trials -- but eight rival companies have already started phase 3 studies. If these players stumble in late-stage trials, however, Novavax could cross the finish line first.

It's not uncommon for developers to hit pause late in the game -- take AstraZeneca NYSE:AZNwhich has temporarily halted its phase 3 study after observing a suspected adverse reaction in an inoculated participant. As long as Novavax sticks to its plan, which is to use the same schedule for its phase 2 study as it implemented for it phase 1 study, it is possible that the company could present phase 2 data to regulators earlier than expected.

On Aug. The two-dose schedule consists of treatments that are administered 21 days apart. In phase 1, researchers performed the primary safety and immune response analysis on day 35 of the study. If enough participants sign up early in the phase 2 trial and the company sticks to its schedule, Novavax may generate some results by late September or early October. Usually, the U. In light of the current health crisis, it's possible the agency will grant an emergency use authorization EUA to a vaccine prior to the availability of phase 3 results.

An EUA does not constitute full approval, but would allow the product to be circulated during the crisis while clinical studies continue. As for trial data, Novavax hasn't yet reported vaccine performance in older volunteers. That information is expected in phase 2 reports.

But phase 1, which studied adults aged 18 through 59, showed positive results. Neutralizing antibodies are important components of immunity, which defend cells against pathogens and infectious particles by disabling or "neutralizing" their adverse biological effects. From a timeline and progress perspective, Novavax isn't a frontrunner. But the company still could be a winner even if it doesn't cross the finish line first.

That's because one healthcare company probably won't be able to provide enough vaccines to meet global demand. It's likely that regulators will approve more than one vaccine candidate if trial results are strong and companies can follow through with manufacturing and delivery.

And in that case, Novavax is still on a great path. The company has also expanded its manufacturing capacity to provide at least 1 billion doses next year.Immunogenicity was measured by hemagglutination inhibition HAI assays using egg-derived reagents. 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.

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.

The webcast can be accessed via a link on the home page of the Novavax website novavax. A replay of the webcast will be available on the Novavax website until June 24, and a replay of the conference call only will be available starting at a. ET on March 24, until a. ET on March 31, To access the conference call replay, dial domestic or international and use passcode The trial enrolled 2, healthy older adults across 19 U.

Trial participants received either NanoFlu or the comparator, both of which were formulated with the four influenza strains recommended for the Northern hemisphere influenza season. Participants will be followed for approximately one year after injection, with primary immunogenicity analyses of the Day 28 sera samples.

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.

Novavax, Inc. Nasdaq:NVAXis a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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. Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements.

Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial

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. 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 SECavailable at sec. 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.

nvax nanoflu

Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Investors Novavax, Inc. Erika Trahan ir novavax. Westwicke John Woolford john.All rights reserved. Charles St, Baltimore, MD Prior to the novel coronavirus, Novavax was in a fight merely to remain in business. Once the company got into the Covid vaccine development arena, however, everything changed.

As is often the case with this sort of fast-moving stock, however, things can change in a hurry. Since its peak on Aug. Management did a great job keeping the company moving forward despite its near-death experience in However, as the odds are starting to turn against the company, traders should be careful.

The race for a Covid vaccine is drawing toward the close. Unfortunately for Novavax, it is not one of the nine companies that have already made it to Phase 3. Novavax got a big leg up on the competition from being one of the few select companies that made it into Operation Warp Speed. But government funding was just one piece of the puzzle; Novavax still has to deliver the goods in clinical trials.

But with every passing week, the window of opportunity is narrowing. Just last year, Novavax appeared to be heading toward extinction.

NVAX stock plummeted so low that it was threatened with delisting from the market. In fact, with shares at 35 cents, Novavax ultimately had to do a reverse split just to keep the stock at a reasonable level. Over the past decade, Novavax has not turned an operating profit. It has a large and well-funded clinical trial for its vaccine.

It is credible from a scientific background and has a reasonable shot of working. While the science checks out, though, the economics are becoming a question mark. As soon as one gets across the finish line, the value of the other rivals will drop sharply.

The company is still intriguing as it has a viable vaccine candidate that could easily be effective. Whether or not it will ever become commercially successful, however, is a less certain matter. Ian Bezek has written more than 1, articles for InvestorPlace. You can reach him on Twitter at irbezek.All rights reserved. Charles St, Baltimore, MD Especially since it has never successfully brought a vaccine to market.

Like a budding sports or entertainment star that comes out of nowhere, Novavax has put in a lot of time and effort over its year history into fine-tuning its vaccine development skills. Now it appears chief executive officer CEOStanley Erck, has the company on the precipice of success. Jumping into the top job, Erck was excited about taking the company to the next level using his previous experience developing vaccines.

Glenn also confirmed that while 5mcg and 25mcg doses will be testedit is the 5mcg dose that will be the focus in future studies. Something tells me this particular underdog has done the preparation work to meet the challenge at hand.

Will Ashworth has written about investments full-time since He particularly enjoys creating model portfolios that stand the test of time. He lives in Halifax, Nova Scotia. At the time of this writing Will Ashworth did not hold a position in any of the aforementioned securities. Log in. Log out. About Us Our Analysts.

nvax nanoflu

Sponsored Headlines. More from InvestorPlace. Stocks to Buy Trump vs. Subscriber Sign in Username. Sign in. Having trouble logging in?Food and Drug Administration FDA granted its next-generation flu vaccine candidate, NanoFlu, fast-track designation for use by adults 65 and over.

The action by the regulatory agency enables more frequent meetings and written communication in order to speed important new drugs to market. NanoFlu is a quadrivalent seasonal influenza that's based on Novavax's recombinant protein nanoparticle technology. Manufacturing traditional flu vaccines involves growing live flu virus in chicken eggs and then killing or weakening the virus, a year-old process that inserts several months of delay between the identification of the virus strains and the availability of the vaccine for that season.

Novavax's recombinant process involves neither live virus nor eggs, and a mid-stage trial showed the vaccine to be more effective than the best-selling flu vaccine in the older adult market.

3 Compelling Reasons to Buy Novavax Right Now

The company hasn't given up on its RSV vaccine, but NanoFlu may be the product to get the stock back on track. Results from a phase 3 trial are expected by the end of this quarter, and could be adequate to support an application for approval. Investing Best Accounts. Stock Market Basics. Stock Market.

Industries to Invest In. Getting Started. Planning for Retirement. Retired: What Now? Personal Finance. The Ascent.

Novavax Wins Fast-Track Designation for Flu Vaccine

About Us. Who Is the Motley Fool? Fool Podcasts. New Ventures. Search Search:. Jan 15, at PM. Author Bio Jim bought his first stocks in with paper route money and has been invested in equities ever since. He's still learning, though, and enjoys studying and investing in a wide variety of businesses. He has a BS and MS in electrical engineering from Stanford University, and retired after 34 years with a large technology company.

Image source: Getty Images.Immunogenicity was measured by hemagglutination inhibition HAI assays using egg-derived reagents.

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.

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.

nvax nanoflu

The webcast can be accessed via a link on the home page of the Novavax website novavax. A replay of the webcast will be available on the Novavax website until June 24, and a replay of the conference call only will be available starting at a. ET on March 24, until a. ET on March 31, To access the conference call replay, dial domestic or international and use passcode The trial enrolled 2, healthy older adults across 19 U. Trial participants received either NanoFlu or the comparator, both of which were formulated with the four influenza strains recommended for the Northern hemisphere influenza season.

Participants will be followed for approximately one year after injection, with primary immunogenicity analyses of the Day 28 sera samples. 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. Novavax, Inc. Nasdaq: NVAXis a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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.

nvax nanoflu

For more information, visit www. 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.

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.

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.There's an old investing adage: "Don't try to catch a falling knife.

The biotech has lost nearly half of its market cap in just one month. That might discourage some investors from even considering buying shares.

1000% STOCK INCREASE AND MY BIGGEST REGRET INVESTING - NVAX ANALYSIS - 100 SUBSCRIBERS FREE GIVEAWAY

However, I'd argue that Novavax should be more attractive to investors now than it has in quite a while. Here are three compelling reasons to buy the biotech stock. It's important to understand that the recent decline in the value of Novavax stock isn't related at all to concerns about its coronavirus vaccine candidate NVX-CoV Actually, the prospects for the vaccine are stronger than ever.

Last week, additional data from the biotech's phase 1 study of the investigational vaccine was published in The New England Journal of Medicine. This data appeared to confirm earlier optimism from Novavax's initial announcement of interim results from the early stage study.

Since the slide for the biotech stock began, Novavax has also lined up additional supply deals. On Aug. The company previously inked a deal with the U. While NVX-CoV gets most of the attention these days, investors shouldn't forget about the opportunities that lie ahead for another of Novavax's pipeline candidates -- NanoFlu.

Where Will Novavax Be in 1 Year?

There's only one remaining hurdle to jump for the flu vaccine candidate before Novavax can seek FDA approval. And that hurdle should be relatively easy.

NanoFlu has already passed the hard part. Novavax reported positive efficacy and safety results from a phase 3 study of the investigational flu vaccine in March. Now, all Novavax needs to do is conduct a lot consistency clinical trial.

The purpose of this trial will be to demonstrate manufacturing consistency in lots of NanoFlu. In the company's Q2 conference call, Novavax CEO Stanley Erck said that the company was exploring alternatives for manufacturing the product required for this clinical trial.

Assuming that NVX-CoV proves to be safe and effective in immunizing against the novel coronavirus, Novavax could be looking at annual sales measured in billions of dollars for the COVID vaccine.

On top of that, H. This prospect makes the biotech's current valuation seem attractive, although risks exist that Novavax's pipeline candidates could stumble. Still, for aggressive investors, Novavax appears to be one of the more appealing clinical-stage biotechs on the market. Investing Best Accounts. Stock Market Basics. Stock Market. Industries to Invest In. Getting Started. Planning for Retirement. Retired: What Now? Personal Finance. The Ascent.


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