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NVAX - Sector: Healthcare --- Industry: Biotechnology & Drugs

Started by fill_the_gap, August 25, 2005, 08:44:09 AM

Previous topic - Next topic

anvilring

The news... just in case someone missed it.

Cdc to Evaluate Novavax's Pandemic Influenza Vaccine Candidate
Tuesday October 31, 7:00 am ET 
First Opportunity To Test Novel Vaccine Against Live Virus


MALVERN, Pa., Oct. 31 /PRNewswire-FirstCall/ -- (Nasdaq: NVAX - News) - Novavax, Inc. said today the U.S. Centers for Disease Control and Prevention (CDC) has agreed to evaluate the company's H5N1 pandemic influenza vaccine candidate, including pre-clinical testing of the vaccine against live bird flu virus.
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"We are pleased that the government has agreed to test the protective efficacy of our vaccine candidate," said Dr. Rick Bright, Novavax's Vice President of Global Influenza Programs. "The CDC, one of a handful of premier infectious disease institutions, has the unique ability to challenge our vaccine with live avian influenza virus."

Under terms of a Cooperative Research Agreement, Novavax will provide the CDC with a supply of the company's virus-like particle (VLP) H5N1 vaccine. Over the past year, Novavax has assembled a significant dossier of pre-clinical data supporting its vaccine which will serve as the basis for the company's investigational new drug application to the U.S. Food and Drug Administration. Novavax is planning to begin human clinical trials using the vaccine during the first half of 2007.

"It is absolutely critical that we are prepared for a potential outbreak of pandemic influenza," said Dr. Terrence Tumpey, Senior Microbiologist at the CDC. "Vaccines like these hold a lot of promise because they offer an attractive alternative to the existing egg-dependent methods for the manufacture of influenza vaccine and have a shorter production lead time which is urgently needed at this time."

Last year, Novavax began collaborating with the CDC to evaluate a vaccine to protect against the H9N2, another subtype of bird flu. "This working relationship further validates the importance of our influenza program and underscores the confidence we have in our influenza VLP vaccine," Dr. Bright said.

VLPs are nearly identical to a virus but do not have the virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to attach to cells and trigger a natural immune response that is capable of protecting against viral infection.


Terliso


Ramsburg

#977
Update:

NVAX was all over the news today: :)
PR Newswire - Cdc to Evaluate Novavax's Pandemic Influenza Vaccine Candidate
Briefing.com - InPlay: Novavax says CDC to evaluate it's H5N1 pandemic influenza vaccine candidate
AP - Novavax to Provide Vaccine for CDC Study
AP - Premarket Movers: Novavax Up on CDC Win
TheStreet.com - Bird Flu Deal Boosts Novavax
bizjournals.com - Novavax's flu vaccine to be checked out
AP - Sector Snap: Bird Flu News Boosts Stocks


The stock had a nice jump, opening with a Gap Up, and holding down the morning gains quite well, volume was almost 3 times above average, and this news flood may be a «wake up call» around NVAX attention.
Taking in consideration the previous consolidation and throwback to the supports, I see this Gap as a «breakaway» candidate, probably NVAX will consolidate the recent gains, but the technical front is getting much better.

Trading Plan:
Hold with a stop @ $3.85

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

#978
Update:
Yesterday's session was suspicious for NVAX... suspicious on a good way... After performing a steady down trend for almost all the session, NVAX had a rebound on the last minutes of the session, recovering from $4.21 to a close at $4.30, volume was big during those minutes, and during after hours trading NVAX jumped another +2.8% to close at $2.42... Apparently no news on this, but taking in consideration the bird flu scenario right now, it seems that some interest may be hidden on this sector...

From a technical approach, NVAX filled the gap from the previous session, which is good in terms of consolidation. I have good short term expectations for this sector.

Trading Plan:
Hold with a stop @ $3.85

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

Update:
Looks like our suspicions were irrelevant, as NVAX just had a complete neutral session, with low volume and not much of price action. We'll stand with the current trading plan:

Trading Plan:
Hold with a stop @ $3.85

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

Update:
Some kind of neutral sessions during the last few days, NVAX seems to have a little short term support near $4.20. Nothing special to comment here, we'll stand with the same trading plan for now.

Trading Plan:
Hold with a stop @ $3.85

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

Ramsburg

Update:
- Novavax Announces Release Date of Third Quarter 2006 Financial Results and Investor Conference Call
(a press release to be issued after 7:00 a.m. EST on Nov. 14, 2006)

Some price action for NVAX with a nice advance and strong volume. NVAX was unable to mark some new relative highs yet, but the chart is looking much better now.
All we need to watch now is a breakout of the $4.70 area, and that should provide a even better setup, the ascending support is standing at $4.25.

Trading Plan:
Hold with a stop @ $3.85

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

fous

NVAX charting shaping up very nicely Rams, I'd consider trading it but i dont want to make an entry right before earnings next week. I'll be taking another look at it next week and see how the market reacts to the results and the effect on the chart pattern.

Heres a chart from a little bit longer term perspective.

-fous
trade it like you mean it!

danman3459

Up 3.5% in Pregaming!

Novavax's Pandemic Influenza Vaccine Candidates Trigger Robust Immune Response In Pre-Clinical Models

PR Newswire - November 08, 2006 7:00 AM ET

Novavax, Inc.'s (Nasdaq: NVAX) novel pandemic influenza vaccine candidates triggered a protective immune response in several pre-clinical studies, according to data to be presented for the first time today at the Fifth World Congress on Vaccines, Immunization and Immunotherapy.

Novavax scientists created four vaccine candidates to protect against four different subtypes of human and avian influenza, including H5N1, the strain that global health officials believe could possibly set off a pandemic outbreak. These virus-like particle (VLP) vaccines, which have the three- dimensional structure of the influenza virus but don't contain genetic material, have been tested in three animal models, said Dr. Rick Bright, Novavax Vice President, Global Influenza Programs.

Data show each vaccine candidate triggered an immune response robust enough to protect against infection at very low doses of vaccine. Two of Novavax's vaccine candidates were tested in ferrets, the influenza animal model that is most relevant to humans. These vaccine candidates produced robust immune responses that provided protection against a variety of influenza strains, including strains not included in the vaccines.

Most influenza vaccines are made from proteins. When compared to a single flu protein of a 2002 influenza virus, Novavax's VLP vaccines raised and broadened the ferrets' immune response more than 3.5 times when tested against that virus. In addition, when the immune response was measured against a different influenza strain from 2004, the response generated by Novavax's VLP vaccines was more than eight times higher than that induced by the single flu protein.

"Our data demonstrate the potential for a single vaccine to protect against a range of influenza strains," Dr. Bright said. "This can be a critical factor in a pandemic situation, since a new vaccine would not have to be created every time the virus mutates," Dr. Bright said. "Our goal is to demonstrate in the clinic that our single H5N1 vaccine protects against new mutations of H5N1 viruses." Novavax plans to begin human clinical trials of its pandemic influenza vaccine during the first half of 2007.

While structurally similar to the live influenza virus, Novavax's VLPs do not have the virus's genetic material required for replication or infection. Upon vaccination, these particles attach to cells and trigger a natural immune response that is capable of protecting against influenza. Novavax also has the capability to scale up manufacture of its influenza vaccines rapidly using portable, disposable equipment. This unique manufacturing system does not rely on traditional egg-based methods for vaccine production, which are complex and require cumbersome equipment and many months of preparation.

The data were generated by Novavax and collaborators at the University of Pittsburgh's Center for Vaccine Research, the Southern Research Institute and the U.S. Centers for Disease Control and Prevention.

About Novavax

Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

SOURCE Novavax, Inc.

Mariann Caprino, +1-484-913-1213

http://www.novavax.com/


D&Data

4.83$ up 7%...200SMA broken,...


Novavax's Pandemic Influenza Vaccine Candidates Trigger Robust Immune Response In Pre-Clinical Models
Wednesday November 8, 7:00 am ET 
New Data Presented at World Congress on Vaccines, Immunization and Immunotherapy


MONTREAL, Nov. 8 /PRNewswire-FirstCall/ -- Novavax, Inc.'s (Nasdaq: NVAX - News) novel pandemic influenza vaccine candidates triggered a protective immune response in several pre-clinical studies, according to data to be presented for the first time today at the Fifth World Congress on Vaccines, Immunization and Immunotherapy.
ADVERTISEMENT


Novavax scientists created four vaccine candidates to protect against four different subtypes of human and avian influenza, including H5N1, the strain that global health officials believe could possibly set off a pandemic outbreak. These virus-like particle (VLP) vaccines, which have the three- dimensional structure of the influenza virus but don't contain genetic material, have been tested in three animal models, said Dr. Rick Bright, Novavax Vice President, Global Influenza Programs.

Data show each vaccine candidate triggered an immune response robust enough to protect against infection at very low doses of vaccine. Two of Novavax's vaccine candidates were tested in ferrets, the influenza animal model that is most relevant to humans. These vaccine candidates produced robust immune responses that provided protection against a variety of influenza strains, including strains not included in the vaccines.

Most influenza vaccines are made from proteins. When compared to a single flu protein of a 2002 influenza virus, Novavax's VLP vaccines raised and broadened the ferrets' immune response more than 3.5 times when tested against that virus. In addition, when the immune response was measured against a different influenza strain from 2004, the response generated by Novavax's VLP vaccines was more than eight times higher than that induced by the single flu protein.

"Our data demonstrate the potential for a single vaccine to protect against a range of influenza strains," Dr. Bright said. "This can be a critical factor in a pandemic situation, since a new vaccine would not have to be created every time the virus mutates," Dr. Bright said. "Our goal is to demonstrate in the clinic that our single H5N1 vaccine protects against new mutations of H5N1 viruses." Novavax plans to begin human clinical trials of its pandemic influenza vaccine during the first half of 2007.

While structurally similar to the live influenza virus, Novavax's VLPs do not have the virus's genetic material required for replication or infection. Upon vaccination, these particles attach to cells and trigger a natural immune response that is capable of protecting against influenza. Novavax also has the capability to scale up manufacture of its influenza vaccines rapidly using portable, disposable equipment. This unique manufacturing system does not rely on traditional egg-based methods for vaccine production, which are complex and require cumbersome equipment and many months of preparation.

The data were generated by Novavax and collaborators at the University of Pittsburgh's Center for Vaccine Research, the Southern Research Institute and the U.S. Centers for Disease Control and Prevention.

Terliso

Quote from: Terliso on October 27, 2006, 02:41:47 AM
This one too ;) I have the target price, top of the channel & also the over head resistance @ $5.50...IMHO ;)

Nice day today ;).... I will sell NVAX just below the price channel a lot of overhead resistance

Thanks Ramsburg for this pick ;)

setravis

Yeaterday's Release..........


MALVERN, Pa., Nov 07, 2006 /PRNewswire-FirstCall via COMTEX/ -- (NVAX, Trade) - Novavax, Inc. today announced that it will report its third quarter financial results in a press release to be issued after 7:00 a.m. EST on Nov. 14, 2006. The Company will hold an investor conference call to discuss its financial results at 10:00 a.m. EST on Nov. 14. The call will be hosted by Mr. Gary C. Evans, Chairman of the Board, and Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. Other participants will include senior management of Novavax. A question and answer session will follow the financial results overview. The dial-in number for the conference call is 1-866-700-7477 (International: 1-617-213-8840), pass code 11738919.

A live audio webcast of the conference call will be available at www.novavax.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days starting on Nov. 14 at www.novavax.com. A replay of the conference call will also be available by telephone beginning Nov. 14, 2006 at noon through Nov. 21. To access the replay, dial 1-888-286-8010 and enter pass code 43667975 followed by the number sign.

About Novavax, Inc.

Novavax, Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.

SOURCE Novavax, Inc.


Mariann Caprino for Novavax, Inc., +1-484-913-1213 

http://www.novavax.com 

Copyright (C) 2006 PR Newswire. All rights reserved ********************************************************************** As of Friday, 11-03-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 08-23-2006 for NVAX @ $3.98. For more information on Comtex SmarTrend? Alert, contact your market data provider or go to www.CSTADirect.com SmarTrend is a registered trademark of Comtex News Network, Inc. Copyright ? 2004-2006 Comtex News Network, Inc. All rights reserved.




"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

ScottishTrader

I am raising my stop on NVAX to 4.57, as, looking at the chart, I think there is the possibility of wednesday's gap and breakout could be a possible bull-trap fakeout.  Overall pattern looks bullish but we do have a large rising wedge, and it is possible that NVAX could break to the downside, despite all the recent positive developments.

Currently NVAX has tested the gap support at 4.62 twice (today and yesterday).  I would like to see bullish confirmation of this double test with a breakout of the intraday descending channel it has been traversing (clearly seen on the 5min chart).  A break below 4.60 would suggest it will at least test the longer term ascending trendline again, which comes in around 4.30 just now.

There is also a possible bearish Wolfewave formation (though to be honest, I don't think the entry to this pattern is correct) with a downside target of 3.80, which could get tagged if 4.30 support gets broken.

Lets just hpe 4.60 holds.

Ramsburg

Update:
NVAX has already closed the gap from the recent move, and is still trading above the breakout level.
We are just going to upgrade our stop level and wait for developments, so the new trading plan is:

Trading Plan:
Hold with a stop @ $4.50

Best regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

ScottishTrader

#989
NVAX ready to pop here - ascending triangle on the 5 min chart.  Once 4.92 gets broken, it should blow through $5.  But man is it a struggle!!!  There's an awful lot sitting on the ask!

c;mon baby  :o