NOVAVAX

[dothedd]

​Ebola, MERS and RSV: Gaithersburg biotech works on making vaccines — and fast 

Oct 3, 2014, 5:17pm EDT

As I chatted with leaders at the Gaithersburg biotech Novavax recently, they mentioned rather nonchalantly that they are scrambling to create a vaccine for Ebola.
Of course I wanted to know more. Unfortunately, the company said they couldn’t release any more information yet. ( What a tease, I know.) But with so much interest in Ebola recently, it was fascinating to talk with the leader of this fast-growing vaccine company.
“Have you seen ‘Contagion’? That’s what we do. We make a vaccine fast,” said Stanley Erck, president and CEO.


And that kind of research is getting increasingly important as global health authorities monitor a growing number of emerging viruses that could spread across borders. “We are seeing more and more of these with people being more mobile,” Erck said.

As its simplest, he said, Novavax's potential vaccines don’t attack the viruses, per se. Rather they go after the proteins that encircle those viruses, a method they say they say has eluded many other drug manufacturers. Earlier this year, my colleague Bill Flook reported the company (Nasdaq: NVAX) raised $115 million by selling 28.75 million shares of its common stock, with plans to pour the money into its research.

The company has yet to bring a vaccine to the market and last year posted a $52 million loss on $20.9 million revenue. But the company says it's getting closer to changing that. It now has 250 employees, with 210 hired in the last three years.

Earlier this year, Novavax announced it created a vaccine candidate to fight Middle East Respiratory Virus, or MERS. The company has worked on both seasonal and pandemic flu vaccines. The likely next big thing from Novavax is a potential vaccine against Respiratory Syncytial Virus (RSV) nano-particle.

If you’ve ever had a kid, you know RSV, the most common cause of inflammation of the small airways in the lung and pneumonia in children under 1 in the U.S. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection, the CDC says. Recently, Novavax announced it was starting a Phase 2 trial of its novel RSV vaccine in pregnant women so antibodies to the virus are transferred in utero to protect infants after they are born. The company hopes to have additional vaccine trials by next year.

In the meantime, Novavax is always monitoring the CDC’s warnings about potential threats from viruses. When scientists see one they think they can address, they download the genetic sequence of the proteins that surround the virus and get to work on it, Erck said.
“All of this is published very quickly now ,” he said. “That’s the good part about the web.
                          

[dothedd]

Insider Trading Alert - NVAX  

Novavax (NVAX) - FREE Research Report

Hahn Timothy Jon, who is SVP, Manufacturing at Novavax, bought 2,500 shares at $4.05 on Oct. 3, 2014. Following this transaction, the SVP, Manufacturing owned 101,156 shares meaning that the stake was boosted by 2.53% with the 2,500-share transaction.

The shares most recently traded at $4.09, up $0.04, or 0.98% since the insider transaction. Historical insider transactions for Novavax go as follows:

The average volume for Novavax has been 3.0 million shares per day over the past 30 days. Novavax has a market cap of $965.6 million and is part of the health care sector and drugs industry. Shares are down 19.73% year-to-date as of the close of trading on Friday.

Novavax, Inc., a clinical-stage biopharmaceutical company, focuses on discovering, developing, and commercializing recombinant protein nanoparticle vaccines and adjuvants. Currently, there are 4 analysts who rate Novavax a buy, no analysts rate it a sell, and none rate it a hold.

[dothedd]

Insider Transaction: $NVAX Purchase at $4.11 per share of 5000 shares by Officer Phillips Barclay A on 2014-10-03.


10/6/14
NVAX
Last: $4.20 (@ 4:00pm)
Change: +0.09
Volume: 2,962,736
Open: $4.16
Day's High: $4.30
Day's Low: $4.08

[dothedd]

3 Biotech Stocks Under $10 in Breakout Territory

NVAX, SVA, OXGN

www.thestreet.com/story/12906541/1/3-biotech-stocks-under-10-in-breakout-territory.html?puc=yahoo&cm_ven=YAHOO

[dothedd]

2014 PRESS RELEASES

Novavax’ H7N9 Avian Influenza VLP Vaccine Candidate with Matrix-M™ Delivers Positive Phase 1/2 Clinical Data 

09/23/14 

Novavax Announces BARDA Exercise of Contract Option 

09/23/14 

Novavax Initiates Phase 2 Clinical Trial of RSV F-Protein Nanoparticle Vaccine Candidate in Healthy Third-Trimester Pregnant Women 

09/16/14 

Novavax to Host 2nd Annual Analyst and Investor Meeting 

09/11/14 

ICAAC Presentation: Immunization of Pregnant Baboons with the RSV F Nanoparticle Vaccine Protects Infant Baboons Challenged with Respiratory Syncytial Virus in a Comparable Manner to Infants Prophylaxed with Palivizumab 

09/08/14 

Novavax Presents Data on RSV F Nanoparticle Vaccine Induced Monoclonal Antibody at ICAAC 

09/06/14 

Novavax to Present RSV Vaccine Preclinical Results at ICAAC 

09/03/14 

Novavax to Present at the Wedbush Securities Life Sciences Management Access Conference 

08/07/14 

Novavax Reports Second-Quarter 2014 Financial Results 

08/06/14 

Novavax to Host Conference Call to Discuss Second Quarter 2014 Financial Results on August 6, 2014 

07/30/14 

Novavax Recognized as One of The Washington Post’s Top Workplaces 

06/23/14 

Novavax Announces Management Promotions 

06/19/14 

Long-Time Novavax Board Member Jack Marsh Assumes Role of Director Emeritus 

06/18/14 

Novavax Announces Exercise of Option to Purchase Additional Shares and Closing of Public Offering 

06/11/14 

Novavax Prices Public Offering of Common Stock 

06/05/14 

Novavax Announces Proposed Public Offering of Common Stock 

06/04/14 

Novavax to Present at the Jefferies 2014 Global Healthcare Conference 

06/02/14 

One Year Follow-up from RSV F-Protein Vaccine Candidate Phase 1 Elderly Trial Demonstrates Sustained Levels of Immune Response 

05/12/14 

Q1 2014 Earnings Release -2014-05-07 Final 

05/07/14 

Novavax Appoints Sven Andréasson as Senior Vice President, Corporate Development 

05/06/14 

Novavax to Report First Quarter Financial Results on May 7, 2014 

05/01/14 

New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 

04/30/14 

Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age 

04/28/14 

Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations 

04/07/14 

Novavax to Present at the 13th Annual Needham Healthcare Conference 

04/02/14 

Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results 

03/10/14 

Novavax Appoints John J. Trizzino as Senior Vice President, Commercial Operations 

03/10/14 

Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS-BARDA 

02/27/14 

Novavax to Report Fourth Quarter and Year-End 2013 Financial Results on March 10, 2014 

02/19/14 

Novavax Announces Management Promotions to Support Expanded Clinical Activity in 2014 

01/13/14 

Novavax Announces Continuation of RSV Vaccine Partnership with PATH 

01/13/14

www.novavax.com/go.cfm?do=Press.List&Year=2014

[dothedd]

Ebola, MERS and RSV: Gaithersburg biotech works on making vaccines — and fast

Washington Business Journal

As I chatted with leaders at the Gaithersburg biotech Novavax recently, they mentioned rather nonchalantly that they are scrambling to create a vaccine for Ebola.

Of course I wanted to know more. Unfortunately, the company said they couldn’t release any more information yet. ( What a tease, I know.) But with so much interest in Ebola recently, it was fascinating to talk with the leader of this fast-growing vaccine company.

“Have you seen ‘Contagion’? That’s what we do. We make a vaccine fast,” said Stanley Erck, president and CEO.

And that kind of research is getting increasingly important as global health authorities monitor a growing number of emerging viruses that could spread across borders. “We are seeing more and more of these with people being more mobile,” Erck said.

As its simplest, he said, Novavax's potential vaccines don’t attack the viruses, per se. Rather they go after the proteins that encircle those viruses, a method they say they say has eluded many other drug manufacturers. Earlier this year, my colleague Bill Flook reported the company (Nasdaq: NVAX) raised $115 million by selling 28.75 million shares of its common stock, with plans to pour the money into its research.

The company has yet to bring a vaccine to the market and last year posted a $52 million loss on $20.9 million revenue. But the company says it's getting closer to changing that. It now has 250 employees, with 210 hired in the last three years.

Earlier this year, Novavax announced it created a vaccine candidate to fight Middle East Respiratory Virus, or MERS. The company has worked on both seasonal and pandemic flu vaccines. The likely next big thing from Novavax is a potential vaccine against Respiratory Syncytial Virus (RSV) nano-particle.

If you’ve ever had a kid, you know RSV, the most common cause of inflammation of the small airways in the lung and pneumonia in children under 1 in the U.S. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection, the CDC says. Recently, Novavax announced it was starting a Phase 2 trial of its novel RSV vaccine in pregnant women so antibodies to the virus are transferred in utero to protect infants after they are born. The company hopes to have additional vaccine trials by next year.

In the meantime, Novavax is always monitoring the CDC’s warnings about potential threats from viruses. When scientists see one they think they can address, they download the genetic sequence of the proteins that surround the virus and get to work on it, Erck said.

“All of this is published very quickly now,” he said. “That’s the good part about the web.”

[Aman A.K.A. Ahamburger]

I found this after reading your email b. Held up well yesterday, I see. On the radar, it is.

JPMorgan Chase & Co. Begins Coverage on Novavax

JPMorgan Chase & Co. began coverage on shares of Novavax (NASDAQ:NVAX) in a report issued on Tuesday, TheFlyOnTheWall.com reports. The firm issued an overweight rating and a $7.00 target price on the stock....

.....Analysts at Piper Jaffray raised their price target on shares of Novavax from $9.00 to $10.50 in a research note on Wednesday, September 24th. They now have an overweight rating on the stock. Separately, analysts at Wedbush initiated coverage on shares of Novavax in a research note on Thursday, September 18th. They set an outperform rating and a $10.00 price target on the stock. Finally, analysts at Citigroup Inc. initiated coverage on shares of Novavax in a research note on Wednesday, August 13th. They set a buy rating and a $9.00 price target on the stock. Seven investment analysts have rated the stock with a buy rating, The company has a consensus rating of Buy and a consensus target price of $9.42.

[dothedd]

Thank you for the update!!  

Major Holders Get Major Holders for:
Breakdown
% of Shares Held by All Insider and 5% Owners: 9%
% of Shares Held by Institutional & Mutual Fund Owners: 45%
% of Float Held by Institutional & Mutual Fund Owners: 49%
Number of Institutions Holding Shares: 87

Major Direct Holders (Forms 3 & 4)
Holder Shares Reported
MODI RAJIV I. N/A Mar 21, 2014
CADILA PHARMACEUTICALS LTD N/A Mar 21, 2014
EVANS GARY C 702,558 Apr 24, 2013
YOUNG JAMES F 425,000 Mar 25, 2014
DOUGLAS RICHARD 250,000 Mar 25, 2014


Top Institutional Holders

Holder Shares % Out Value* Reported
Price (T.Rowe) Associates Inc 10,214,700 4.28 47,191,914 Jun 30, 2014
BlackRock Fund Advisors 7,089,127 2.97 32,751,766 Jun 30, 2014
Invesco Ltd. 7,071,863 2.97 32,672,007 Jun 30, 2014
Vanguard Group, Inc. (The) 6,831,384 2.87 31,560,994 Jun 30, 2014
RA Capital Management, LLC 6,661,731 2.79 30,777,197 Jun 30, 2014
BlackRock Institutional Trust Company, N.A. 6,330,055 2.66 29,244,854 Jun 30, 2014
State Street Corporation 6,166,949 2.59 28,491,304 Jun 30, 2014
FMR, LLC 24,914,161 10.45 115,103,423 Jun 30, 2014
Camber Capital Management, LLC 4,750,000 1.99 21,945,000 Jun 30, 2014
Wells Fargo & Company 4,729,781 1.98 21,851,588 Jun 30, 2014

Top Mutual Fund Holders

Holder Shares % Out Value* Reported

Fidelity Select Portfolios - Biotechnology 14,411,821 6.04 66,582,613 Jun 30, 2014
Powershares Exhg Traded Fd-Dynamic Pharmaceuticals Port 7,071,863 2.97 32,672,007 Jun 30, 2014
Vanguard Total Stock Market Index Fund 3,106,604 1.30 14,072,916 Mar 31, 2014
iShares Russell 2000 ETF 3,096,451 1.30 14,305,603 Jun 30, 2014
Fidelity Small Cap Opportunities Fund 2,979,562 1.25 13,050,481 Apr 30, 2014
Wells Fargo Advantage Discovery Fd 2,672,667 1.12 12,347,721 Jun 30, 2014
SPDR (R) Ser Tr-SPDR (R) S&P (R) Biotech ETF 2,657,864 1.11 12,518,539 May 31, 2014
iShares NASDAQ Biotechnology ETF 2,451,614 1.03 11,326,456 Jun 30, 2014
Price (T.Rowe) Health Sciences Fund 2,450,200 1.03 11,099,406 Mar 31, 2014
Fidelity Advisor Biotechnology Fund 2,301,331 0.97 10,632,149 Jun 30, 2014

finance.yahoo.com/q/mh?s=NVAX+Major+Holders

[dothedd]

Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine  

Induces Antigenic Site II Antibodies 

• Vaccinated Animals Generated a Broad Spectrum of Protective Antibodies
• Vaccine Induces Antibodies that are at Least as Protective as Palivizumab
• Palivizumab Competing Antibody Response from Vaccine Protects Against Both

Gaithersburg, MD – October 15, 2014 – Novavax, Inc. (Nasdaq: NVAX) a clinical-stage
biopharmaceutical company focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced that its RSV F-protein
nanoparticle vaccine candidate (RSV F Vaccine) evoked a polyclonal antibody response to
antigenic site II, the same site targeted by the monoclonal antibody palivizumab (Synagis®),
resulting in protection from an RSV challenge in an animal model. Researchers at Novavax
reported these findings in an online paper published by Vaccine titled: “An insect cell derived
respiratory syncytial virus (RSV) F nanoparticle vaccine induces antigenic site II antibodies and protects against RSV challenge in cotton rats by active and passive immunization.”

“This study further characterizes the immune response to our RSV F Vaccine, including the
production of both polyclonal palivizumab competing antibodies that target antigenic site II, as
well as other neutralizing antigenic sites on the F-protein,” said Greg Glenn, SVP, Research and
Development at Novavax. “In addition, our ability to assess the safety of our RSV F Vaccine
relative to Lot 100 formalin inactivated vaccine, which is known to cause disease enhancement,
and to demonstrate that our vaccine’s efficacy is equivalent or better than palivizumab, gives us greater confidence that our RSV vaccine candidate will be both safe and effective.”

Continued:  www.novavax.com/download/releases/Novavax%20Study%20Published%20in%20Vaccine%20-%20RSV%20F-Protein%20Nanoparticle%20Vaccine%20Induces%20Antigenic%20Site%20II%20Antibodies.pdf

[dothedd]

VIDEO

Novavax CEO: 'Avian Flu Results Very Positive for Vaccine Maker' - Presented by: The Aol. On Network

Novavax's recent positive avian flu results demonstrate the company can make vaccines quickly and for a wide range of viruses including Ebola, said the company's CEO Stanley Erck.

www.nasdaq.com/video/novavax-ceo--avian-flu-results-very-positive-for-vaccine-maker-518429286

[dothedd]

NVAX PPS:  5.09  0.40(8.53%) 2:34PM EDT
                    5.08  0.39(8.32%) 2:35PM EDT

        
NVAX PPS: 5.15 Up 0.46(9.81%) 2:40PM EDT

NVAX PPS:    5.17 Up 0.48(10.24%)

NVAX PPS: 5.24 Up 0.55(11.73%) 2:43PM EDT

NVAX PPS: 5.25 Up 0.56(11.94%) 2:44PM EDT

[dothedd]

www.hhs.gov/news/press/2014pres/10/20141016a.html

FOR IMMEDIATE RELEASE

16-Oct-14
Contact: HHS Press Office
202-690-6343
HHS advances development of third Ebola vaccine
Studies will prepare vaccine candidate for clinical trials

The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). 

Under a one-year contract with Profectus BioSciences Inc., headquartered in Baltimore, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide approximately $5.8 million in funding, in addition to subject matter expertise and technical assistance, to further develop an experimental Ebola vaccine. The company will manufacture vaccine for use in animal safety studies and future clinical trials and conduct animal studies to test safety. The contract can be extended to a total of 13 months and $8.6 million.

Upon successful completion of this work, the company is expected to submit an investigational new drug application to the U.S. Food and Drug Administration (FDA). This application, once accepted by the FDA, would allow the vaccine to begin the first clinical trials for safety in humans.

“We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease,” said BARDA Director Robin Robinson, Ph.D.  “Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”

The project builds on early research of this experimental vaccine supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and animal studies supported by the Department of Defense. In the DoD-supported studies, a single dose of the experimental Ebola vaccine provided 100 percent protection in non-human primates. BARDA will support further development of the vaccine against the Ebola virus strain responsible for the current epidemic.

Clinical trials are under way with other experimental vaccines. NIAID currently is supporting Phase 1 clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.

BARDA also continues to explore how its Centers for Innovation in Advanced Development and Manufacturing, itsFill Finish Manufacturing Network, or other measures can accelerate the manufacturing time for Ebola therapeutics and vaccines.

The agency is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 athttps://www.fbo.gov.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

For more information about advanced research and development of medical countermeasures, visitwww.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.

[dothedd]

Novavax, Inc.

5.18  0.49(10.45%) 3:37PM EDT
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[dothedd]

                

     

[dothedd]

Manufacturing GM position posted in Ahmendabad 

Manufacturing Operations 

1) Formulating manufacturing policies and program in consultation with CEO to ensure total implementation from concept to commercialization..
2) Working in collaboration with Novavax, lead the CPLB technical team to develop robust, high producing and economically viable production process.
3) Ensure availability of all products within specified quality norms and marketing plan, through production planning and control, coordinating material requirements.

Quality Assurance & Quality Control
1) Formulate programs to ensure quality products and services conforming to Quality parameters set by various agencies and customers

Research & Development
Responsible for planning and directing the companys engineering activities including strategic priorities relating to creation, design and development of the organizations products, in conjunction with R& & Engineering support functions.
Salary:INR 22,50,000 - 35,00,000 P.A
Industry:Pharma / Biotech / Clinical Research
Farea:Production, Manufacturing, Maintenance
Role Category:Senior Management
Role:Head/VP/GM-Production/Manufacturing/Maintenance

[dothedd]

Yale Grad Student in Isolation

The patient, a Yale researcher, had recently returned from Liberia, one of three West African countries hit hardest by the disease. The patient had traveled to the country to study the virus and returned to Connecticut last week.

Duh, do you think we need a travel ban?  

[dothedd]

Novavax (NVAX) Shows Strength: Stock Adds 10.1% in Session 

Zacks By Zacks Equity Research
7 hours ago

Novavax, Inc. (NVAX) was a big mover last session, as its shares rose a little over 10% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This breaks the recent trend for the company, as the stock is now trading above the volatile price range of $4.05 to $4.69 in the past one-month time frame.

In the last 30 days, the company did not witness any estimate revision while the Zacks Consensus Estimate moved lower, signaling trouble down the road. So make sure to keep an eye on this stock going forward to see if yesterday’s move higher lasts.  

[dothedd]

NOVAVAX - October 2014 PRESS RELEASES 

Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine Induces Antigenic Site II Antibodies
10/15/14

Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine in Elderly Subjects
10/14/14

[dothedd]

PRESS RELEASES

Biotech Equities Technical Analysis - ARIAD Pharma, Novavax, Galena Bi... 15 Oct 2014 - PR Newswire

Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine... 15 Oct 2014 - Globe Newswire

Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine in Elderly Sub... 14 Oct 2014 - Globe Newswire

Novavax Announces BARDA Exercise of Contract Option 23 Sep 2014 - Globe Newswire


Novavax' H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM) ... 23 Sep 2014 - Globe Newswire
data.cnbc.com/quotes/NVAX/tab/5?viewtype=more

[dothedd]

Headlines
Novavax to Present RSV Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26 GlobeNewswire(Thu 4:15PM EDT)


4.99 Up 0.14(2.89%) 4:00PM EDT
After Hours : 4.9906 Up 0.00 (0.01%) 4:43PM EDT

[dothedd]

NOVAVAX  

GAITHERSBURG, Md., Oct. 23, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that Gregory Glenn, M.D., Senior Vice President, Research and Development at Novavax will present new immunogenicity data from Novavax' RSV F-Protein Nanoparticle vaccine candidate (RSV F vaccine) clinical trials at the 8th Vaccine & ISV Congress to be held October 26-28, 2014 in Philadelphia, PA at the Hilton Philadelphia City Avenue Hotel.


Novavax to Present RSV Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26

Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine Induces Antigenic Site II Antibodies

Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine in Elderly Subjects
More Press Release for Novav

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5.13 9:58AM EDT
5.1238  0.1338(2.68%) 9:58AM EDT
5.15  0.16(3.21%) 9:58AM EDT
5.15  0.16(3.21%) 9:59AM EDT
5.1499  0.1599(3.20%) 9:59AM EDT - Nasdaq 
5.16  0.17(3.41%) 10:03AM EDT 
5.1670  0.1770(3.55%) 10:04AM EDT 
5.18  0.19(3.81%) 10:05AM EDT 
5.17  0.18(3.61%) 10:05AM EDT 
5.16  0.17(3.41%) 10:05AM EDT 
5.17 Up 0.18(3.61%) 10:10AM EDT

[dothedd]

Novavax Presents RSV F Protein Nanoparticle Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26 Thomson Reuters ONE - Sun Oct 26, 2:10PM UTC
- Thu Jan 01, 12:00AM UTC

Novavax Has Returned 13.9% Since SmarTrend Recommendation (NVAX) Comtex SmarTrend(R) - Fri Oct 24, 4:10PM UTC

Novavax to Present RSV Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26 Thomson Reuters ONE - Thu Oct 23, 8:24PM UTC
Uptrend Call Working As Novavax Stock Rises 10.5% (NVAX) Comtex SmarTrend(R) - Fri Oct 17, 3:08PM UTC

Novavax (NVAX) Moves Up: Stock Adds 10.1% in Session - Tale of the Tape Zacks Investment Research - Fri Oct 17, 1:39PM UTC

Novavax Begins Mid-Stage Study on RSV Vaccine in Elders - Analyst Blog Zacks Investment Research - Wed Oct 15, 9:20PM UTC
Biotech Equities Technical Analysis - ARIAD Pharma, Novavax, Galena Biopharma, Geron, and Celldex Therapeutics PR Newswire - Wed Oct 15, 12:40PM UTC

10/24/14
Novavax Inc (NVAX)Follow + Alert + Portfolio
5.13+0.14 (+2.81%) 7:04P EDT (NASDAQ)

[dothedd]

2014 PRESS RELEASES 

Novavax Announces Ebola Vaccine Development Program at the 8th Vaccine and ISV Conference in Philadelphia
10/27/14

Novavax Presents RSV F Protein Nanoparticle Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26
10/26/14

Novavax to Present RSV Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26
10/23/14

Novavax Study Published in Vaccine: RSV F-Protein Nanoparticle Vaccine Induces Antigenic Site II Antibodies
10/15/14

Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine in Elderly Subjects
10/14/14

Novavax’ H7N9 Avian Influenza VLP Vaccine Candidate with Matrix-M™ Delivers Positive Phase 1/2 Clinical Data
09/23/14

Novavax Announces BARDA Exercise of Contract Option
09/23/14

Novavax Initiates Phase 2 Clinical Trial of RSV F-Protein Nanoparticle Vaccine Candidate in Healthy Third-Trimester Pregnant Women
09/16/14

Novavax to Host 2nd Annual Analyst and Investor Meeting
09/11/14

ICAAC Presentation: Immunization of Pregnant Baboons with the RSV F Nanoparticle Vaccine Protects Infant Baboons Challenged with Respiratory Syncytial Virus in a Comparable Manner to Infants Prophylaxed with Palivizumab
09/08/14

Novavax Presents Data on RSV F Nanoparticle Vaccine Induced Monoclonal Antibody at ICAAC
09/06/14

Novavax to Present RSV Vaccine Preclinical Results at ICAAC
09/03/14

Novavax to Present at the Wedbush Securities Life Sciences Management Access Conference
08/07/14

Novavax Reports Second-Quarter 2014 Financial Results
08/06/14

Novavax to Host Conference Call to Discuss Second Quarter 2014 Financial Results on August 6, 2014
07/30/14

Novavax Recognized as One of The Washington Post’s Top Workplaces
06/23/14

Novavax Announces Management Promotions
06/19/14

Long-Time Novavax Board Member Jack Marsh Assumes Role of Director Emeritus
06/18/14

Novavax Announces Exercise of Option to Purchase Additional Shares and Closing of Public Offering
06/11/14

Novavax Prices Public Offering of Common Stock
06/05/14

Novavax Announces Proposed Public Offering of Common Stock
06/04/14

Novavax to Present at the Jefferies 2014 Global Healthcare Conference
06/02/14

One Year Follow-up from RSV F-Protein Vaccine Candidate Phase 1 Elderly Trial Demonstrates Sustained Levels of Immune Response
05/12/14

Q1 2014 Earnings Release -2014-05-07 Final
05/07/14

Novavax Appoints Sven Andréasson as Senior Vice President, Corporate Development
05/06/14

Novavax to Report First Quarter Financial Results on May 7, 2014
05/01/14

New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
04/30/14

Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age
04/28/14

Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations
04/07/14

Novavax to Present at the 13th Annual Needham Healthcare Conference
04/02/14

Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results
03/10/14

Novavax Appoints John J. Trizzino as Senior Vice President, Commercial Operations
03/10/14

Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS-BARDA
02/27/14

Novavax to Report Fourth Quarter and Year-End 2013 Financial Results on March 10, 2014
02/19/14

Novavax Announces Management Promotions to Support Expanded Clinical Activity in 2014
01/13/14

Novavax Announces Continuation of RSV Vaccine Partnership with PATH
01/13/14


www.novavax.com/go.cfm?do=Press.List&Year=2014

[dothedd]

MONDAY - 10 27 14 

Novavax (NVAX) Presents Data on EBOV GP Vaccine 

Novavax (NASDAQ: NVAX) announced that Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax, presented at the 8th Vaccine and ISV Conference in Philadelphia on Sunday, October 26. Dr. Smith's presentation was titled: 2014 Guinea Ebola Virus Recombinant Glycoprotein (GP) Nanoparticle Vaccine was Highly Immunogenic and Cross-Neutralized 1976 Virus GP Pseudovirus.
Dr. Smith reported on Novavax' Ebola GP recombinant nanoparticle vaccine candidate (EBOV GP Vaccine), which is based on the 2014 Guinea Ebola strain that is responsible for the current Ebola disease epidemic in West Africa. In preclinical models, the EBOV GP Vaccine induced antibody titers against the homologous 2014 Guinea Ebola GP in the range of 103 to 104 (ELISA EC 90). Aluminum phosphate as an adjuvant resulted in a modest adjuvant effect; however, the Company's proprietary adjuvant Matrix-M™ enhanced anti-Ebola GP responses by 10 to 100 fold, inducing Ebola GP antibody titers of 105 to 106 (ELISA EC90). Importantly, EBOV GP vaccine plus Matrix-M induced serum cross-neutralization to the older Ebola 1976 (Mayinga) GP-VSV pseudotype. The EBOV GP Vaccine, adjuvanted with Novavax' Matrix-M adjuvant, induced anti-GP ELISA and neutralizing antibody levels well within ranges reported to protect against Ebola viruses in rodent and non-human primate models.

"We are developing our recombinant Ebola GP vaccine using the same platform we used to develop vaccine candidates against several pathogens including respiratory syncytial virus (RSV), seasonal and pandemic influenza, and Middle Eastern Respiratory Syndrome (MERS)," said Stanley C. Erck, President and CEO. "Our proprietary platform allows us to quickly develop, and manufacture an Ebola vaccine candidate at large scale, which we believe can provide a necessary tool to fight this global health crisis."

Novavax has recently initiated a non-human primate study and expects to initiate a Phase 1 clinical trial in December 2014 to evaluate the safety and immunogenicity of the EBOV GP Vaccine in ascending doses, with and without the Matrix-M adjuvant, in approximately 150 subjects. Plans to demonstrate the safety and efficacy in a large-scale global clinical trial will be developed based on data from the Phase 1 trial and in collaboration with global regulatory authorities and world health agencies.
"We used the recently published Guinea 2014 Ebola strain genetic sequence1 to create a highly purified, correctly folded, Ebola GP Vaccine in only a few weeks," said Gregory Glenn, M.D., SVP, Research and Development at Novavax. "The data presented today provides scientific validation that our technology platform can respond to emerging viral threats in an extremely efficient and effective manner. We look forward to the results of our non-human primate study and the initiation of a Phase 1 clinical trial in the near future."

The Novavax EBOV GP Vaccine may also address other key requirements for a successful vaccine against this viral threat: (1) like Novavax' other recombinant vaccines, it appears to not require frozen storage allowing for easier transport and more efficient global distribution; (2) manufacturing could be rapidly scaled to millions of doses a month, based on the Company's experience in scale-up and manufacturing with its other nanoparticle vaccine candidates, and; (3) the preclinical data suggest that the Matrix-M adjuvant enhances immunogenicity with lower doses of antigen, which would further leverage the company's ability to manufacture and supply significant doses.

Novavax Announces Ebola Vaccine Development Program at the 8th Vaccine and ISV Conference in Philadelphia

First Ebola Vaccine Candidate based on the 2014 Guinea Ebola Strain Genetic Sequence
Robust immune responses demonstrated in preclinical studies; exceptional responses when used with Novavax' Matrix-M™ adjuvant
Non-human primate study initiated
GMP manufacture initiated; Scaled-up manufacturing to begin 1st quarter 2015
Phase 1 clinical trial anticipated to start in December 2014

www.streetinsider.com/Press+Releases/Novavax+Announces+Ebola+Vaccine+Development+Program+at+the+8th+Vaccine+and+ISV+Conference+in+Philadelphia/9942209.html

[dothedd]

GAITHERSBURG, Md., Oct. 27, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX) today announced that Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax, presented at the 8th Vaccine and ISV Conference in Philadelphia on Sunday, October 26. Dr. Smith's presentation was titled: 2014 Guinea Ebola Virus Recombinant Glycoprotein (GP) Nanoparticle Vaccine was Highly Immunogenic and Cross-Neutralized 1976 Virus GP Pseudovirus.

Dr. Smith reported on Novavax' Ebola GP recombinant nanoparticle vaccine candidate (EBOV GP Vaccine), which is based on the 2014 Guinea Ebola strain that is responsible for the current Ebola disease epidemic in West Africa. In preclinical models, the EBOV GP Vaccine induced antibody titers against the homologous 2014 Guinea Ebola GP in the range of 103 to 104 (ELISA EC 90). Aluminum phosphate as an adjuvant resulted in a modest adjuvant effect; however, the Company's proprietary adjuvant Matrix-M™ enhanced anti-Ebola GP responses by 10 to 100 fold, inducing Ebola GP antibody titers of 105 to 106 (ELISA EC90). Importantly, EBOV GP vaccine plus Matrix-M induced serum cross-neutralization to the older Ebola 1976 (Mayinga) GP-VSV pseudotype. The EBOV GP Vaccine, adjuvanted with Novavax' Matrix-M adjuvant, induced anti-GP ELISA and neutralizing antibody levels well within ranges reported to protect against Ebola viruses in rodent and non-human primate models.

"We are developing our recombinant Ebola GP vaccine using the same platform we used to develop vaccine candidates against several pathogens including respiratory syncytial virus (RSV), seasonal and pandemic influenza, and Middle Eastern Respiratory Syndrome (MERS)," said Stanley C. Erck, President and CEO. "Our proprietary platform allows us to quickly develop, and manufacture an Ebola vaccine candidate at large scale, which we believe can provide a necessary tool to fight this global health crisis."

Novavax has recently initiated a non-human primate study and expects to initiate a Phase 1 clinical trial in December 2014 to evaluate the safety and immunogenicity of the EBOV GP Vaccine in ascending doses, with and without the Matrix-M adjuvant, in approximately 150 subjects. Plans to demonstrate the safety and efficacy in a large-scale global clinical trial will be developed based on data from the Phase 1 trial and in collaboration with global regulatory authorities and world health agencies.
"We used the recently published Guinea 2014 Ebola strain genetic sequence1 to create a highly purified, correctly folded, Ebola GP Vaccine in only a few weeks," said Gregory Glenn, M.D., SVP, Research and Development at Novavax. "The data presented today provides scientific validation that our technology platform can respond to emerging viral threats in an extremely efficient and effective manner. We look forward to the results of our non-human primate study and the initiation of a Phase 1 clinical trial in the near future."

The Novavax EBOV GP Vaccine may also address other key requirements for a successful vaccine against this viral threat: (1) like Novavax' other recombinant vaccines, it appears to not require frozen storage allowing for easier transport and more efficient global distribution; (2) manufacturing could be rapidly scaled to millions of doses a month, based on the Company's experience in scale-up and manufacturing with its other nanoparticle vaccine candidates, and; (3) the preclinical data suggest that the Matrix-M adjuvant enhances immunogenicity with lower doses of antigen, which would further leverage the company's ability to manufacture and supply significant doses.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax has vaccine candidates in late stage clinical trials for respiratory syncytial virus, and for seasonal and pandemic influenza. Additional information about Novavax is available on the company's website, novavax.com.

[dothedd]

NVAX

Price: $5.80 +13.06%

Overall Analyst Rating:
BUY (Up Up)

[dothedd]

Novavax, Inc. Watchlist

5.80+0.67(13.09%)
NasdaqGS -- 2:59PM EST


5.81+0.68(13.26%)
NasdaqGS2:59PM EST


Novavax, Inc. (NVAX) -NasdaqGS
5.80 Up 0.67(13.06%) 4:00PM EDT
After Hours : 5.83 Up 0.03 (0.52%) 4:01PM EDT

Novavax, Inc. (NVAX) -NasdaqGS  In Watchlist
5.81 Up 0.68(13.26%) 4:00PM EDT
After Hours : 5.84 Up 0.04 (0.69%) 4:02PM EDT

5.81 Up 0.68(13.26%) 4:00PM EDT
After Hours : 5.83 Up 0.03 (0.52%) 4:03PM ED

5.81 Up 0.68(13.26%) 4:00PM EDT
After Hours : 5.83 Up 0.03 (0.52%) 4:04PM EDT

[dothedd]

Healthcare Top Gainers

Published On: Tue, Oct 28th, 2014 Finance | By Evan Cavise
Healthcare Top Gainers: Novavax, Inc. (NASDAQ:NVAX), Regulus Therapeutics Inc. (NASDAQ:RGLS), Chembio Diagnostics, Inc. (NASDAQ:CEMI)


Novavax, Inc. (NASDAQ:NVAX) [Trend Analysis] released that Gale Smith, Ph.D., VP of Vaccine Development at Novavax, presented at the 8th Vaccine and ISV Conference in Philadelphia on Sunday, October 26. Dr. Smith’s presentation was titled: 2014 Guinea Ebola Virus Recombinant Glycoprotein (GP) Nanoparticle Vaccine was Highly Immunogenic and Cross-Neutralized 1976 Virus GP Pseudovirus. Novavax, Inc. (NASDAQ:NVAX) stock closed at $5.80 in last session with the total traded volume of 23.27 Million.The Financial Institutional ownership of the firm was 58.60% while by insiders was 44.13%.

[dothedd]

Gaithersburg-based Novavax developing vaccine to prevent spread of Ebola

October 28 at 5:10 PM   

Gaithersburg-based Novavax, a life sciences company that develops vaccines for infectious diseases, could begin testing a vaccine to stem the spread of Ebola in humans as soon as December, the company’s chief executive said.

Continued: www.washingtonpost.com/business/capitalbusiness/gaithersburg-based-novavax-developing-vaccine-to-prevent-spread-of-ebola/2014/10/28/eee08850-5ee0-11e4-8b9e-2ccdac31a031_story.html?

[dothedd]

Novavax To Launch Clinical Trial Of Ebola Vaccine; Sarepta Announces Update On Eteplirsen 

BioMedReports 

Tuesday, October 28, 2014 4:14 AM EDT 

Novavax, Inc. (NASDAQ: NVAX) will launch a Phase 1 clinical trial of an Ebola vaccine candidate in December, the company said at a conference Sunday in Philadelphia.

Novavax gained 5 percent in Monday's session, trading recently at $5.36 per share.

Vice President of Vaccine Development Gale Smith said in a news release Monday that in pre-clinical models, its glycoprotein recombinant nanoparticle vaccine candidate produced antibody levels "well within ranges" thought to protect against Ebola in rodents and monkeys.

Separately at the conference, Novavax said its vaccine candidate for influenza among newborns, pediatrics and elderly, could also benefit pregnant women.

A Phase 2 clinical trial in 330 women of childbearing age showed the vaccine reduced infections by 50 percent, the company said.