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Novavax, Inc. (NVAX)
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I'm seeing Wall St. rotate money back to the vaccine sector with the Delta plus variant - and get the vaccine sector out of the bear market & get us back above $210, because we all know covid is not over. Fauci (I don't like the guy at all, but he says 5th Wave could come with a large population still unvaccinated. Merck's stock price has fallen to $77 from $85, indicating that Wall. St. has now doubts about it being a magic pill.
For earnings, there are a couple of things I'm hanging on to:
(1) Thierry Breton's statement "pleased to see Novavax production sites across Europe getting ready to supply vaccines to the World"
(2) Novavax paid news w/ the Guardian "Novavax expected to be the first protein subunit Covid19 vaccine available to the European Union"
(3) Novavax Launch team - launching Novavax Brand awareness and new logo, hiring people for commercialization and product launch, Novavax launches ads for brand awareness.
(4) Novavax enters $374 M deal with Mabon for commercial production launch in Dec. 2021
(5) India Study done October (this month)
(6) UK Novavax Booster Study - (this month)
We should get PR before earnings on EUA submissions like the last time, or even Approval.
Johnny Lawrence II
Oct 18, 3:24 pm
CDC now counts those with AstraZeneca, Novavax shots as ‘fully vaccinated’
The Centers for Disease Control and Prevention updated its definition of what it means to be “fully vaccinated” to include people who got the AstraZeneca and Novavax doses in clinical trials.
A person also should be considered fully immunized even if they mix their vaccines, the CDC announced Monday.
In general, people are considered fully vaccinated two weeks after their second dose in a two-dose series, such as the Pfizer-BioNTech or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s vaccine
The new guidance applies to COVID-19 vaccines currently approved or authorized for emergency use by the U.S. Food and Drug Administration — Pfizer-BioNTech, Moderna, and Johnson & Johnson — and can be applied to COVID-19 vaccines that have been listed for emergency use by the World Health Organization, such as AstraZeneca and Oxford.
The CDC is not recommending vaccines that are not FDA-authorized and has not yet made a decision on official guidelines for mixing doses.
The new guidance on interpreting vaccine records does not impact CDC recommendations on primary series vaccination and should not guide clinical practice, according to the CDC.
Valneva announced a successful phase-3 trial today. The trial was not an efficacy trial. Instead, it was a non-inferiority trial comparing Valneva against AstraZeneca based on immune responses. The actual results were not that great, NAbs titer 39% better than a pretty bad AstraZeneca vaccine. That was not anywhere close to the immune response data from Novavax and Moderna, perhaps similar to Pfizer at best.
The fact that the trial was to compare immune responses from two different vaccines enabled the trial to skirt around the question of how efficacious the Valneva vaccine is in an environment full of variants beyond the original D162G Wuhan virus. And, it also allowed for a much smaller enrollment, just 4000 patients. It's really interesting that a major regulatory agency, MHRA, is now comfortable with the idea of running such a trial for licensing approval of a Covid vaccine.
For NVAX, that thinking is good for future development of variant vaccines such as rS-B.1.351 after Cov2373 approval. It'll also make it easier to advance Nanoflu (which was also tested in a non-inferiority immune response trial) and any combination flu+Covid vaccine.
Maryland-based Novavax, Inc. announced on October 15, 2021, that Vivek Shinde, M.D., Vice President, Clinical Development, will deliver a presentation during the World Vaccine Congress Europe 2021. A topic of discussion on October 20, 2021, will be Novavax's COVID-NanoFlu™ combination vaccine.
This combo vaccine combines the company's recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccines with Matrix-M™ adjuvant in a single formulation.
In preclinical studies, the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role.
Separately, NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials.
In September 2021, Novavax announced the publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu in The Lancet Infectious Diseases. In the full analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.
"Despite high vaccination rates, limitations in the effectiveness of existing influenza vaccines leave significant disease burden unaddressed, particularly in older adults," stated Stanley C. Erck, President, and CEO, Novavax, in a press release issued on September 23, 2021. "These encouraging (study) results reflect NanoFlu's promise, especially as we currently have a combination COVID-19-influenza vaccine under evaluation for protection against two life-threatening diseases simultaneously."
Novavax, Inc. is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.
Note: The European Medicines Agency started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.), in early 2021.
When this thing fell to $120 and then went back to over $250 I remember thinking I should
Have loaded up.
Hard part is when your at the $120 of course you are worried it could drop further.
When you count up all of the bench marks nvax has hit, from excellent study results, EU signing deal, to WHO submissions and other than some delays no real big devastating negative news, Merck news is not relevant, as it is not even in competition, honestly its hard to fathom a legit good reason why it would drop
From $270 to $160 in just weeks.
The vaccine works.
In fact it works very very well!
The world need vaccines!
Nvax unless can be proven to be lying has indicated they are producing 100M a month.
On any approval anywhere it’s hard to not believe the sp will be north of $500 in a very short time.
Market cap of
35-40 B is not unrealistic at all!
I think many would believe that is super conservative.
So I think we all know the stock is manipulated.
Question is when will it hit bottom.
Billion dollar question.
There is no indication that Covid is about to finish soon. People are tired of measures and it's becoming politically more difficult to impose lockdowns. But what does that have to do with vaccination? If anything, vaccination is more important than ever. It will become a permanent thing. Waning immunity means everyone will have to revaccinate and no country will give free pass to those with "natural immunity" because it's hard to administer that, they will also have to vaccinate and revaccinate. Therefore, horizon for vaccines market will last for many more years. And vaccines can be mixed, so those who took Pfizer and othe vaccines are still potential customers of novavax. Given all these facts - there is no rush to enter the market before Covid is finished - because covid will never finish. Just like the flue has never disappeared. As this becomes more apparent market will have to adjust.
Focus on the last statement of this new Seeking Alpha article;
"Moderna, Pfizer forecast for a combined $93.2B in COVID vaccine sales in 2022 - FT
Oct. 18, 2021 8:07 AM ETModerna, Inc. (MRNA), BNTX,PFE,JNJAZN, NVAXBy: Jonathan M Block, SA News Editor
Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) are forecast to have a combined $93.2B in COVID-19 vaccine sales next year, the Financial Times reports.
That estimate comes from health data analytics firm Airfinity, who projects the producers of the mRNA vaccines will control three-fourth of the non-China COVID-19 vaccine market in 2022.
Pfizer (PFE) is projected to have $54.5B in COVID vaccine revenue, while the figure for Moderna (MRNA) is $38.7B.
Airfinity says its estimates are supported by middle- and high-income countries buying booster shots.
The firm said that other manufacturers, including AstraZeneca (NASDAQ:AZN), Johnson & Johnson (NYSE:JNJ), and Novavax (NASDAQ:NVAX) will bring in $124B next year."
Just published: interview with Novavax and UK's NIHR:
Seth Toback - Vice President, Clinical Development-Coronavirus vaccines
Divya Chadha Manek - Director of Business Development (NIHR Clinical Research Network)
Seth: "we're working with the UK continuously (...) and as a final act, once our vaccine is authorized in the UK, we plan on using some of their (...) data collection systems, basically their national database, to do further safety studies on the vaccine".
Seth: "in terms of future plans we are still doing research in the UK (...) in a multitude of smaller studies which are really designed to answer some policy questions about mixing and matching vaccines, about giving booster doses, (...) giving doses to inmunocompromised people".
Seth: "I think it is important to remember that the work we're doing is very complex, especially the work of our vaccine. Our vaccine creates a protein that's a three-dimensional highly folded complicated biologic and we need to get it exactly right. Although our vaccine is not yet authorized in the UK, we're still at pace for an unprecedented speed (...) we're working tirelessly to make sure we can make our submission to the NIHR as fast as we can".
Still no specific date for submission, but why would they be working on additional studies and be talking about approval so clearly in front of an NIHR representative if this wasn't the case?
Seth Toback, Novavax and Divya Chadha Manek, National Institute for Health Research (NIHR) (EP.97)
The work with Novavax is proceeding as planned, to prepare for the production of the Novavax vaccine candidate at the BMC. This includes working on the technology transfer to establish the step-by-step process of producing the Novavax vaccine at the facility.
The vaccine, developed by the US-based biotechnology company, has not currently been approved anywhere in the world. However, infectious diseases physician and microbiologist Associate Professor Paul Griffin, who was a Principal Investigator for the Novavax vaccine’s phase 1/2 study in Australia, believes that could soon change.
‘I wouldn’t be surprised if approvals start to flow with that vaccine in a number of countries,’ Associate Professor Griffin told newsGP.
‘Given the very rigorous regulatory process here, it’s likely to be a little bit of time after, but I wouldn’t be surprised if the approval comes before the end of the year at this rate.’
A Department of Health (DoH) spokesperson told newsGP the TGA will be ready to proceed with an application as soon as Novavax supplies the required data.
‘The TGA can only make a regulatory decision on the Novavax vaccine once the complete data package has been provided by the sponsor to enable the required regulatory processes,’ the spokesperson said.
‘It is, therefore, not possible to speculate on timeframes at this stage.’
The spokesperson said if the vaccine is found to be safe and effective, its rollout could begin in December – and that general practice would be involved.
‘If approved, GPs will assist in the rollout of the Novavax vaccine as with other vaccines in the current rollout,’ the spokesperson said.
The vaccine can be stored at normal refrigerator temperatures, which would help facilitate its use in general practice and remote areas.
"News Issued: Oct 18, 2021 (9:15am EDT)
To view this online and get more information about Novavax Investor Relations visit:
Novavax to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights on November 4, 2021
GAITHERSBURG, Md., Oct. 18, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2021 financial results and operational highlights on Thursday, November 4, 2021, following the close of U.S. financial markets. Details of the event and replay are as follows:
Conference call details:
November 4, 2021
4:30 p.m. U.S. Eastern Daylight Time (EDT)
(877) 870-426 (Domestic) or (412) 317-0790 (International)
Participants will be prompted to request to join the Novavax, Inc. call.
To ensure a timely connection, it is recommended that participants join at least 10 minutes prior to the scheduled webcast.
Available starting at 7:30 p.m. EDT, November 4, 2021 until 11:59 p.m. U.S. Standard Time, November 11, 2021
(877) 344-7529 (Domestic) or (412) 317-0088 (International)
, until February 4, 2022"
What to expect near term:
1. Submission EU and UK. There is a crucial approval meeting Nov. 8 in EU, so Novavax has to apply 1-2 weeks ahead of that, that’s this or next week. Right after this we will see submission to Australia, Canada.
2. India regulatories should have the last documents from Indian trial in October, whereafter they, Indonesia, Philippines and WHO will approve. Maybe they already got it!!!!
3. Results from UK mix-trial this or next week.
Who will be the first to approve. I think EU or UK
It’s the darkest before light my fellow longs. Novavax is producing @100 million doses now and all evidence points to successful commercialization. SP will go high, very high and our investment will pay off. Don’t forget that you are investing, not trading. Remember that Novavax has only published good news since the price was at 260. Remember that pill has caused an emotional reaction but is completely irrelevant and markets will adjust.We will walk out of this as millionaires and as investors who literally saved the fing world. If not for worldwide vaccination there will be no end to this problem and even western countries will have to face the music again. That’s why getting it absolutely right is so very important.
Everyone should listen to the uk trial interview: Finalizing submission and unexpectedly they have all 15,000 enrollees tracking against delta still as part of the post meadurement. Thats a massive sample. Very positive.
One thing of note on the UK call. Seth (head of trial) mentions that he is transitioning role to management of rollout (in UK). That is a small comment that speaks billions and is now consistent with the recent pattern. Also there are Vaccine discussion meetings at EMA on Wednesday and FDA last week of Oct. DGCI and WHO are in that same window too. So filings go in in next 5 days.
“I have hundreds of patients who do not want "new technology" vaccines. They're ALL worried about effects 10yrs down the line. Novavax will be a TOTAL game changer. There is very high trust in the community for his jab n I genuinely believe that overnight our vax rate will be the highest in the world with this. We need this now! Most of patients have been asking me when /if this will be combined with the flu jab. Makes complete sense because as predicted our flu jab uptake is back to below pre-covid days because no one can be bothered with 3 jabs this yr.“ - Dr Vishal Kohli
Tweet from Gottlieb; "UK reported its biggest one-day Covid case increase in 3 months just as the new delta variant AY.4 with the S:Y145H mutation in the spike reaches 8% of UK sequenced cases. We need urgent research to figure out if this delta plus is more transmissible, has partial immune evasion?"
There is little chance, it seems to me, that the CEO would have had a publicized meeting with Thierry Bretton if the Company weren't on the very cusp of approvals, shipping, jabbing and significant revenue. I very much expect news of approvals from WHO, EU, possibly UK and others prior to the EC.
The sp could easily jump $100 within two weeks.
Important News 📰
FDA to allow people to get different vac than the initial one as booster
New York Times
MANY MILLIONAIRES WILL BE MADE WITH NOVAVAX VACCINE.--- DON'T LET THEM STEAL YOUR SHARES
Typically biotech companies have to get their drugs approved by the U.S. Food and Drug Administration (FDA) and other regulatory agencies before any revenues start rolling in. But COVID-19 is a strange situation. Governments are stockpiling the drugs ahead of time. The U.S., for instance, paid $1.8 billion to Novavax last year to pre-order 100 million doses of its vaccine candidate.
That's why Novavax has been receiving cash (and recognizing revenues) prior to its vaccine hitting the market. The company's already seeing tremendous revenues, even while its vaccine has yet to receive an emergency use authorization (EUA). While Novavax's revenue growth is sky-high right now, that's because it's jumping off a tiny base. Nonetheless, Novavax's amazing growth story is just getting started.
I'm expecting EUAs around the world to start escalating as we head deeper into the fourth quarter. And the future looks bright as well, with Novavax running a clinical trial in humans for its COVID/flu combo vaccine candidate. The small biotech is first out of the gate with a combo vaccine, so we'll see if it can keep its lead over mRNA competitors like Moderna (NASDAQ: MRNA) or Pfizer (NYSE: PFE), and BioNTech (NASDAQ: BNTX). An annual COVID/flu vaccination is a powerful long-term phenomenon, and right now Novavax is winning that race.
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