NOVAVAX

[dothedd]

- NVAX is published in the NEJM: The best PR, period. NVAX’s H7N9 results are worthy of an “early online release.”

- RSV is the leading cause of hospitalizations in infants under . This is a Multi-billion dollar market. Even better… combine RSV with seasonal influenza for new COMBO vaccine.. Protect the young, the old…and the unborn…

- MTSL: Medical Technology Stock Newsletter… (The highest rated and most successful newsletter of its kind). The MTSL Loves NVAX… NVAX is one of their top picks for 2014.& 2015. NVAX is considered an M&A target.

- Institutional Support: Near 65%

- TOP PICK: NVAX is listed in the TOP PICKS BY… Lazard, FBR Capitol, Piper Jaffray, Jay Silverman (MTSL), Peter Kolchinsky's RA Capital Management... and now even Cramer.

- THE VLP PLATORM: Not only, Faster, but... Safer, Most Cost-effective… WSJ calls it a “A Game Changer”.

- MANUFACTURING: Flexible, optimized and ready to go…

- PANDEMIC PREPAEREDNESS: NVAX poised to be the worldwide Pandemic Preparedness solution. (Flu, Ebola, MERS etc.)

- MIRACULOUS MATRIX: Proprietary saponin-base adjuvant (Matrix-M). A proven Winner,

- TEAM: NVAX has an outstanding team of world class scientists and proven executives.

- NVAX Tech/Platform called 'Disruptive' by Ted Tenthoff of Piper Jaffray. (PJ meets with NVAX today in Denver.)

[dothedd]

TRENDS & DEVELOPMENTS IN BIOPROCESS TECHNOLOGY 

Abstract
For the ongoing 2014 Ebola virus outbreak, all viable options and technologies need to be evaluated as potential countermeasures to address this emerging biological threat. Novavax, Inc. has a rapid, practical vaccine development and manufacturing platform with the capability to deliver clinical trial material and, ultimately, commercial doses in response to novel infectious disease agents.

[1-3]
This report describes the application of our platform technology for the successful generation, manufacture, and release of a clinical batch of Zaire ebolavirus glycoprotein nanoparticle vaccine three months from project initiation. The key enabling
factors were:
• An integrated project plan and frequent cross-functional response team meetings
• Forward processing of intermediates prior to completion of quality control
testing
• Rapid development and confirmation of the platform process at laboratory-scale
• Advanced use of the baculovirus master virus seed to bypass production of the working virus seed
• Rapid analytical method development
• A manufacturing process that employs single-use manufacturing
technology
• Collaboration and flexibility from key raw material suppliers and contracted service providers Introduction

In 1976, a new virus (later designated genus Ebolavirus), which caused acute hemorrhagic fever in people of Zaire (now the Democratic Republic of Congo) was reported.[4] Since then, five ebolavirus species have been identified.

The species designated Zaire ebolavirus (EBOV), Sudan ebolavirus, and Bundibugyo ebolavirus have caused multiple, major Ebola virus disease (EVD) outbreaks in Africa.[5] From 1976 to 2013, EVD is estimated to have claimed the lives of 1590 people.[6]

In March 2014, the United Nations World Health Organization (WHO) was notified of a new outbreak of EVD in Guinea that had expanded to Liberia.

Further outbreaks were identified in Sierra Leone (May) and Nigeria (July).[6]

In August, WHO DirectorGeneral
Dr.  Margaret Chan declared a public health emergency of international concern, characterizing
the 2014 EVD outbreak as “the largest, By TIMOTHY J. HAHN, BRIAN WEBB, JOHN KUTNEY, ED FIX, NANCY NIDEL, JAMES WONG, DANA JENDREK, CELIA BAULA, JODY  LICHAA, MIKE SOWERS, YE V. LIU, JOHN HIGGINS, KWAN-HO ROH, ZHENG MENG, CYNTHIA OLIVER, ERICA SHANE, LARRY ELLINGSWORTH, SARATHI BODDAPATI, CHRISTI MCDOWELL-PATTERSON, ZIPING WEI, OLEG BORISOV, WIN CHEUNG, JINGNING  LI, VICTOR GAVRILOV, KATHLEEN CALLAHAN, KARIN LÖVGREN BENGTSSON, MAGNUS SÄVENHED, MATS SJÖLUND, SUSANNA MACMILLAR, MALIN SCHENERFELT, LINDA STERTMAN, CAMILLA ANDERSSON, KATARINA RANLUND, JENNY REIMER, DENISE COURBRON, STEPHEN J. BEARMAN, VALERIE MOORE, . NIGEL THOMAS, AMY B. FIX, LOUIS F. FRIES, GREGORY M. GLENN, and GALE E. SMITH

Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology IMAGE: Created by microbiologist Cynthia Goldsmith, Centers for Disease Control and Prevention (CDC), this colorized transmission electron micrograph (TEM) revealed some of the ultrastructural morphology displayed by an Ebola virus virion. (http://phil.cdc.gov/phil/details.asp?pid=10816) Article Published Online: February 10, 2015

[dothedd]

MCMANUS MICHAEL A JR 

FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934, Section 17(a) of the Public Utility Holding Company Act of 1935 or Section 30(h) of the Investment Company Act of 1940 OMB APPROVAL
OMB Number: 3235-0287
Expires: December 31, 2014
Estimated average burden
hours per response 0.5



Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
1. Name and Address of Reporting Person*
MCMANUS MICHAEL A JR





(Last) (First) (Middle)
C/O NOVAVAX, INC., 20 FIRSTFIELD ROAD




(Street)
GAITHERSBURG MD 20878





(City) (State) (Zip)
2. Issuer Name and Ticker or Trading Symbol
NOVAVAX INC [NVAX] 5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
X Director 10% Owner
Officer (give title below) Other (specify below)


3. Date of Earliest Transaction (Month/Day/Year)
02/20/2015
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)
X Form filed by One Reporting Person
Form filed by More than One Reporting Person


Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I)
(Instr. 4) 7. Nature of Indirect Beneficial Ownership
(Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 02/20/2015 M 15,000 A $ 1.48 92,590 D
Common Stock 02/20/2015 M 15,000 A $ 2.61 107,590 D
Common Stock 02/20/2015 M 15,000 A $ 2.35 122,590 D


Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
( e.g. , puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security
(Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code
(Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4, and 5) 6. Date Exercisable and Expiration Date
(Month/Day/Year) 7. Title and Amount of Underlying Securities
(Instr. 3 and 4) 8. Price of Derivative Security
(Instr. 5) 9. Number of Derivative Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I)
(Instr. 4) 11. Nature of Indirect Beneficial Ownership
(Instr. 4)

Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares

Stock Option (Right to buy) $ 1.48 02/20/2015 M 15,000 11/04/2005 05/04/2015 Common Stock 15,000 $ 0 0 D
Stock Option (Right to buy) $ 2.61 02/20/2015 M 15,000 09/06/2008 03/06/2018 Common Stock 15,000 $ 0 0 D
Stock Option (Right to buy) $ 2.35 02/20/2015 M 15,000 09/15/2010 03/15/2020 Common Stock 15,000 $ 0 0 D


Explanation of Responses:
/s/ John A. Herrmann III, Attorney-in-Fact 02/24/2015
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4(b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB Number.

[dothedd]

MCMANUS MICHAEL A JR

FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934, Section 17(a) of the Public Utility Holding Company Act of 1935 or Section 30(h) of the Investment Company Act of 1940 OMB APPROVAL
OMB Number: 3235-0287

ir.novavax.com/phoenix.zhtml?c=71178&p=irol-sec

[dothedd]

Q4 2014 Novavax Inc Earnings Conference CallThursday, February 26, 2015, 4:30 pm EST

 edge.media-server.com/m/p/wr6ioscf

[dothedd]

4:30 pm NOVAVAX CONFERENCE 

OR ... GO TO THE NOVAVAX WEBSITE AND ENTER ON THERE!

www.novavax.com/go.cfm?do=Page.View&pid=36

[dothedd]

Novavax - Buy The Dip For The Long Term 

Mar. 3, 2015 3:01 AM ET | About: Novavax, Inc. (NVAX)
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours....


seekingalpha.com/article/2967316-novavax-buy-the-dip-for-the-long-term?auth_param=rm88j:1afaqj0:55cddb1db828af3c590d9b54fa1581cc&dr=1

[dothedd]

NEXT EVENT:  May 7, 2015, 4:30 p.m. ET


Novavax First Quarter Financial Results
Gaithersburg, Maryland
May 7, 2015, 4:30 p.m. ET
Dial-in: 877-212-6076 (domestic) or 707-287-9331 (international)
Conference ID: 35660022
Webcast: click here: ir.novavax.com/phoenix.zhtml?c=71178&p=irol-news&nyo=0

[dothedd]

A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant


ClinicalTrials.gov Identifier:
NCT02078674
First received: March 3, 2014
Last updated: May 13, 2014
Last verified: May 2014
History of Changes:


History of Changes and the ClinicalTrials.gov Archive Site

Information in a ClinicalTrials.gov record can be modified at any time by the data provider.
The display at ClinicalTrials.gov shows the most recent version for each data element.
The date first received and the date last updated are listed at the top of each record.
The full history of changes since the record was first received is available in the
archival version of the record on the ClinicalTrials.gov Archive Site.

Current Study:
ClinicalTrials.gov Identifier: NCT02078674
Study Title: A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
First Received: March 3, 2014
Last Updated: May 13, 2014
Continue to the history of changes for this study on the ClinicalTrials.gov Archive Site

clinicaltrials.gov/archive/NCT02078674


CONTINUED:  clinicaltrials.gov/show/NCT02078674

[dothedd]

Novavax First Quarter Financial Results
Gaithersburg, Maryland

May 7, 2015, 4:30 p.m. ET
Dial-in: 877-212-6076 (domestic) or 707-287-9331 (international)
Conference ID: 35660022


edge.media-server.com/m/p/consphro

[dothedd]

RSV - CLINICAL TRIALS

RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women
Status: Ongoing, not recruiting Identifier: NCT0224776

A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Pediatrics
Status: Recruiting Identifier: NCT02296463

Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Seniors
Status: Ongoing, not recruiting Identifier: NCT02266628

RSV F Dose-Ranging Study in Women
Status: Completed Identifier: NCT01960686

RSV-F Vaccine Dose Ranging Study in Young Women
Status: Completed Identifier: NCT01704365

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
Status: Completed Identifier: NCT01290419

RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
Status: Completed

[dothedd]

NVAX PPS 5 21 15

8.87 0.03(0.38%) 9:55AM EDT
8.86 0.02(0.17%) 9:57AM EDT
Day's Range: 8.79 - 8.90
52wk Range: 3.92 - 9.95
Volume: 200,644
8.83 0.0
1(0.11%) 9:58AM EDT
8.82 0.02(0.23%) 9:59AM EDT
8.85 0.01(0.11%) 10:01AM EDT
8.83 0.01(0.08%) 10:03AM EDT
8.90 0.07(0.74%) 10:09AM EDT
8.82 0.02(0.23%) 10:39AM EDT
8.83 0.01(0.11%) 10:40AM EDT
8.82 0.02(0.17%) 10:41AM EDT
8.84 0.01(0.06%) 10:41AM EDT
8.86 0.02(0.28%) 10:46AM EDT
8.87 0.03(0.34%) 11:03AM EDT 433,606
8.88 0.04(0.45%) 11:07AM EDT
8.82 0.02(0.23%) 11:25AM EDT 493,871
8.81 0.03(0.40%) 11:32AM EDT 530,262
8.83 0.01(0.11%) 11:33AM EDT
8.80 0.04(0.45%) 11:34AM EDT
8.83 0.01(0.11%) 12:50PM EDT
8.83 0.01(0.11%) 12:53PM EDT
8.84 0.00(0.00%) 12:57PM EDT
8.84 0.01(0.06%) 1:00PM EDT
8.82 0.02(0.20%) 1:00PM EDT

[dothedd]

NVAX (Common Stock)

Price 8.87 Change + 0.01

Volume 1,509,092 % Change 0.11%
Intraday High 8.99 52 Week High 9.95
Intraday Low 8.81 52 Week Low 3.92
Today's Open 8.84 Currency US Dollar
Previous Close 8.86 Exchange NASDAQ GS
05/22/15 4:00 p.m. ET

CLINICAL TRIALS
RSV

RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women
Status: Ongoing, not recruiting Identifier: NCT0224776

A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Pediatrics
Status: Recruiting Identifier: NCT02296463

Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Seniors
Status: Ongoing, not recruiting Identifier: NCT02266628

RSV F Dose-Ranging Study in Women
Status: Completed Identifier: NCT01960686

RSV-F Vaccine Dose Ranging Study in Young Women
Status: Completed Identifier: NCT01704365

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
Status: Completed Identifier: NCT01290419

RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
Status: Completed Identifier: NCT01709019

SEASONAL INFLUENZA

Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
Status: Ongoing, not recruiting Identifier: NCT02307851

A Study to Evaluate the Immune Response and Safety of a Seasonal Influenza VLP Vaccine
Status: Completed Identifier: NCT01561768

Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza VLP Vaccine
Status: Completed Identifier: NCT00903552

Evaluate the Safety and immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Adults
Status: Completed Identifier: NCT00754455

Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
Status: Completed Identifier: NCT01014806

PANDEMIC AND EMERGING VIRUSES

EBOLA

Study to Evaluate the Immunogenicity and Safety of an Ebola Virus Glycoprotein Vaccine
Status: Ongoing, not recruiting Identifier: NCT0237589

PANDEMIC INFLUENZA

A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
Status: Ongoing, not recruiting Identifier: NCT02078674

A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1
Status: Completed Identifier: NCT01897701

A/H5N1 Virus-Like Particle Antigen Dose Ranging Study with Adjuvant 1
Status: Completed Identifier: NCT01594320

A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
Status: Completed Identifier: NCT01596725

Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
Status: Completed Identifier: NCT00519389

Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
Status: Completed Identifier: NCT01072799

Please see our Clinical-Stage Pipeline for more information on the vaccine candidates in these clinical trials.
Please see our Press Releases for more information regarding data announcements from these clinical trials.

[dothedd]

Day's Range: 8.95 - 9.13

52wk Range: 3.92 - 9.95

Volume: 1,332,419

9.09 0.09(1.00%) 9:30AM EDT (5/29/15) OPEN
9.11 0.11(1.28%) 9:31AM EDT
9.12 0.12(1.28%) 9:31AM EDT
9.09 0.09(1.00%) 9:32AM EDT
9.11 0.11(1.22%) 9:32AM EDT
9.12 0.12(1.33%) 9:32AM EDT
9.11 0.11(1.22%) 9:32AM EDT
9.09 0.09(1.00%) 9:34AM EDT
9.12 0.12(1.33%) 9:34AM EDT
9.10 0.10(1.11%) 9:34AM EDT
9.13 0.13(1.44%) 9:35AM EDT
9.12 0.12(1.35%) 9:35AM EDT
9.10 0.10(1.35%) 9:35AM EDT
9.12 0.12(1.33%) 9:36AM EDT
9.11 0.11(1.22%) 9:36AM EDT

Day's Range: 9.08 - 9.13
52wk Range: 3.92 - 9.95
Volume: 147,122

9.08 0.08(0.89%) 9:37AM EDT
9.10 0.10(1.11%) 9:38AM EDT 160,008
9.08 0.08(0.89%) 9:43AM EDT
9.09 0.09(1.00%) 9:44AM EDT
Day's Range: 9.08 - 9.13
52wk Range: 3.92 - 9.95
Volume: 200,727

9:45 AM
9.10 0.10(1.11%) 9:45AM EDT
Day's Range: 9.08 - 9.13
52wk Range: 3.92 - 9.95
Volume: 201,607 9:356 AM


9.09 0.09(1.00%) 11:03AM EDT
9.10 0.10(1.11%) 11:04AM EDT
9.11 0.11(1.28%) 11:04AM EDT
9.09 0.09(1.00%) 11:23AM EDT
9.10 0.09(1.06%) 11:24AM EDT 
9.09 0.09(1.00%) 11:25AM EDT
Volume: 1,337,986
9.04 0.04(0.39%) 11:32AM EDT

MERS Watch: News Video 6/1/2015

[dothedd]

Gaithersburg biotech expands into new research facility,
preps for last phase of drug trials...

A new 54,000-square-foot research and development facility in Gaithersburg signals…


Gaithersburg-based Novavax Inc. — known for its work developing vaccine candidates for the flu, a pediatric respiratory illness and Ebola — expanded into a new 54,000-square-foot research and development space where it plans to house its vaccine work.

"It's a very important signal of our continued growth," said Buck Phillips, chief financial officer of Novavax (Nasdaq: NVAX) of the new space at 21 Firstfield Road, across the street from its headquarters.

The company, which specializes in a process that it says creates new vaccine candidates more quickly than what's on the market now, has more than doubled in size in two years to 349 employees, expecting to raise that to 400 employees by the end of the year, Phillips said. Novavax already leases a combined 74,000 square feet at 20 and 22 Firstfield Road, mostly laboratory and manufacturing space, in part to support a massive federal flu vaccine contract.


CONTINUED:
www.bizjournals.com/washington/blog/2015/06/gaithersburg-biotech-expands-into-new-research.html

[dothedd]

Date           Open High Low Close Volume Adj Close*
Jun 5, 2015 8.73 8.81 8.37 8.81  2,218,900   8.81
Jun 4, 2015 8.88 8.97 8.65 8.76  1,760,600   8.76
Jun 3, 2015 8.93 8.99 8.84 8.91  1,940,500   8.91
Jun 2, 2015 8.89 8.95 8.74 8.89  4,303,900   8.89
Jun 1, 2015 9.09 9.13 8.80 8.94  5,409,000   8.94
May 29, 2015 8.82 9.02 8.80 9.00 2,945,400 9.00
May 28, 2015 8.95 9.05 8.70 8.84 5,377,600 8.84
May 27, 2015 8.94 9.00 8.82 8.99 2,119,100 8.99
May 26, 2015 8.83 8.92 8.77 8.89 1,577,200 8.89
May 22, 2015 8.84 8.99 8.81 8.87 1,509,100 8.87
May 21, 2015 8.79 8.91 8.75 8.86 1,432,100 8.86
May 20, 2015 8.74 8.94 8.61 8.84 1,682,700 8.84
May 19, 2015 8.73 8.81 8.65 8.74 1,288,700 8.74
May 18, 2015 8.50 8.75 8.43 8.72 2,208,800 8.72
May 15, 2015 8.64 8.67 8.43 8.54 1,592,400 8.54
May 14, 2015 8.52 8.74 8.28 8.63 2,368,000 8.63
May 13, 2015 8.58 8.67 8.43 8.47 1,888,600 8.47
May 12, 2015 8.47 8.62 8.32 8.51 2,349,800 8.51
May 11, 2015 8.25 8.59 8.23 8.52 2,798,300 8.52
May 8, 2015 7.89 8.32 7.85 8.23   3,992,200 8.23
May 7, 2015 7.80 7.98 7.68 7.89 2,877,400 7.89
May 6, 2015 7.72 7.95 7.65 7.88 3,519,000 7.88
May 5, 2015 8.01 8.05 7.60 7.66 5,064,000 7.66
May 4, 2015 7.97 8.17 7.92 8.04 3,043,200 8.04
May 1, 2015 7.83 7.96 7.69 7.95 3,539,800 7.95

[dothedd]

2015 

Jun 19, 2015
Novavax Recognized by Washington Post as Top Workplace
Jun 18, 2015
Novavax Appoints Gail Boudreaux to Board
Jun 15, 2015
Novavax Announces Management Promotion

[dothedd]

Novavax, Inc. (NVAX) 
9.38 Down 0.15(1.57%) 4:00PM EDT
After Hours : 9.43 Up 0.05 (0.53%) 4:36PM EDT

Day's Range: 9.38 - 9.57
52wk Range: 3.92 - 9.95
Volume: 6,265,436

Press Releases Get Press Releases for:
Friday, June 19, 2015

Novavax Recognized by Washington Post as Top WorkplaceGlobeNewswire( (Fri 8:00AM EDT)
Thursday, June 18, 2015

Novavax Appoints Gail Boudreaux to BoardGlobeNewswire( (Thu, Jun 18)
Monday, June 15, 2015

Novavax Announces Management PromotionGlobeNewswire( (Mon, Jun 15)
Thursday, May 7, 2015

[dothedd]

Novavax Appoints Gail Boudreaux To Board

The following excerpt is from the company's SEC filing.

Gaithersburg, Md., June 18, 2015 – Novavax, Inc., (Nasdaq: NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Gail K. Boudreaux to its Board of Directors.

“We are delighted to welcome Gail to Novavax’ Board,” said Stanley C. Erck, President and CEO of Novavax. “Her outstanding leadership and business experience will be important to our continued growth and success. Gail’s insight on health payors will be particularly important as we continue to move towards commercializatio n of our vaccines.”

Ms. Boudreaux most recently served as the Executive Vice President of UnitedHealth Group from May 2008 until February 2015 and was the Chief Executive Officer of UnitedHealthcare from January 2011 to November 2014. Her extensive experience includes more than 30 years of service across a broad spectrum of health care operations.

Ms. Boudreaux is currently a director of Zimmer Holdings, Inc. and Xcel Energy Inc. and a trustee of Dartmouth College

Ms. Boudreaux holds a Master of Business Administration degree in finance and health care administration from the Columbia Business School and a bachelor’s degree in psychology from Dartmouth College. She has been honored as one of Fortune’s 50 Most Powerful Women in American Business for the last six years and was recognized by Modern Healthcare as one of the Top 25 Women in Healthcare.

“I am very happy to be joining Novavax at such an exciting time,” said Ms. Boudreaux. “I look forward to helping the company achieve its goal to develop and deliver safe and effective vaccines to improve global heath.”

[dothedd]

Novavax, Inc. (NVAX) 

11.11 Down 0.07(0.67%) 3:59PM EDT
www.novavax.com/

NOVAVAX RECOGNIZED BY WASHINGTON POST AS TOP WORKPLACE
GAITHERSBURG, Md., June 19, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that, for the second consecutive year, it has been recognized as a Top Workplace for 2015.

“This recognition is a testament to the passion and dedication of our 350 SuperNovas,” said Stanley C. Erck, President and CEO. “Our employees exemplify the excellence and commitment necessary to make an impact on global health. I come to work every day excited to work with each and every one of them.”

The Washington Post Top Workplaces are determined solely on employee feedback via an employee survey conducted by WorkplaceDynamics, LLP, a leading research firm on organizational health and employee engagement.

Jill Hoyt, Vice President, Human Resources, said, “It is an honor to receive this recognition for the second year in a row. This award underscores Novavax’ commitment to creating a culture where our employees are a key part of innovative solutions, cutting-edge technology and shared success.”

The Washington Post publishes the complete list of Top Workplaces on June 21st. For more information about the Top Workplaces lists, please visit www.topworkplaces.com.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.

[dothedd]

Gaithersburg biotech expands into new research facility, preps for last phase of drug trials 

Jun 4, 2015, 3:02pm EDT Updated Jun 4, 2015, 3:41pm EDT

Gaithersburg-based Novavax Inc. — known for its work developing vaccine candidates for the flu, a pediatric respiratory illness and Ebola — expanded into a new 54,000-square-foot research and development space where it plans to house its vaccine work.
"It's a very important signal of our continued growth," said Buck Phillips, chief financial officer of Novavax (Nasdaq: NVAX) of the new space at 21 Firstfield Road, across the street from its headquarters.

The company, which specializes in a process that it says creates new vaccine candidates more quickly than what's on the market now, has more than doubled in size in two years to 349 employees, expecting to raise that to 400 employees by the end of the year, Phillips said. Novavax already leases a combined 74,000 square feet at 20 and 22 Firstfield Road, mostly laboratory and manufacturing space, in part to support a massive federal flu vaccine contract.

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Novavax also said it has begun manufacturing a vaccine for potential Phase 3 clinical trials of its leading vaccine candidate for respiratory syncytial virus, or RSV. RSV is the most common cause of inflammation of the small airways in the lung and pneumonia in children under 1 in the U.S., but impacts other age groups as well. Novavax has been in the midst of Phase 2 trials of its RSV vaccine in pregnant women and for elderly patients.

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Novavax's Ebola vaccine is in hot pursuit of 

GSK, Merck, J&J candidates 

February 18, 2015 

Novavax ($NVAX) announced on Thursday that it would take its Ebola 

candidate to Australia for a Phase I trial involving 230 healthy adults. It is the 

fourth company to bring an Ebola vaccine to human trials--behind Big 

Pharmas GlaxoSmithKline ($GSK), Merck ($MRK) and Johnson & Johnson 

($JNJ)--but Novavax isn't worried. Novavax's R&  chief, Dr. Greg Glenn, 

says it has a better vaccine.

"The need for an Ebola vaccine is not going to go away. … I think there's 

going to be a need for a very good vaccine. I think this vaccine is really a 

high-quality construct and we intend to see it developed," Glenn told 

FierceVaccines. 

The Ebola GP vaccine is named so because it's a glycoprotein (GP) 

recombinant nanoparticle jab. This differentiates it from the other candidates 

in development, which are all vector-based. 

In vector-based vaccines, there can be a mismatch between the strain that is causing the disease and 

the predicted strain used to make the vaccine, like in this year's flu shot, Glenn said. 

The other vaccines that have been deployed in the field "have been matched to old strains of Ebola," 

he said. What's different about Novavax's vaccine is that the gene sequence it uses is matched to the 

sequence of the strain that is causing the current epidemic. 

The immunity induced by the Ebola GP vaccine is "more robust" than that offered by vaccines being 

deployed in the field, Glenn said. In a nonhuman primate challenge, the vaccine provoked the 

creation of "high-quality antibodies" and lots of them. It also requires a very low dose due to its 

adjuvant, Matrix-M. 

The smaller dose, coupled with Novavax's capacity to produce millions of doses each month, could 

make it a key player in the Ebola vaccine arena. Early data from Glaxo's trial suggest that a single 

dose of its candidate may not trigger an immune response strong enough to fend off Ebola.

"[Novavax's] goal is to accelerate the development of this vaccine through funding collaborations 

with any one of a number of global healthcare entities or U.S. governmental entities," said Barclay 

"Buck" Phillips, Novavax chief financial officer.

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Quadrivalent Seasonal Influenza Flu Clinical Data - Release Imminent 

After checking on clinical trials site, the enrollment for the Phase II seasonal influenza clinical trial was closed by December 8, 2014. And the trial is only for 6 months, so if that would be the latest June 8, 2015 that all subjects have been followed and reported to the clinical sites. Let's say it takes them 2-3 weeks to gather all of the data, lock the data, and unblind it for Novavax. Then, Novavax will take the un-blinded data and perform the statistical analysis. I don't really think it is that complicated, it is basically 4 groups with multiple primary and secondary endpoints. It should take them about 1-2 weeks to enter all of the data for 400 patients and complete that statistical analysis. If the result is good, then it should be easy to analyze and draft the PR.

So the PR can come at anytime in the next few weeks.

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PRESS RELEASE


NOVAVAX APPOINTS GAIL BOUDREAUX TO BOARD

GAITHERSBURG, Md., June 18, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Gail K. Boudreaux to its Board of Directors.

“We are delighted to welcome Gail to Novavax’ Board,” said Stanley C. Erck, President and CEO of Novavax. “Her outstanding leadership and business experience will be important to our continued growth and success. Gail’s insight on health payors will be particularly important as we continue to move towards commercialization of our vaccines.”

Ms. Boudreaux most recently served as the Executive Vice President of UnitedHealth Group from May 2008 until February 2015 and was the Chief Executive Officer of UnitedHealthcare from January 2011 to November 2014. Her extensive experience includes more than 30 years of service across a broad spectrum of health care operations. Ms. Boudreaux is currently a director of Zimmer Holdings, Inc. and Xcel Energy Inc. and a trustee of Dartmouth College. Ms. Boudreaux holds a Master of Business Administration degree in finance and health care administration from the Columbia Business School and a bachelor’s degree in psychology from Dartmouth College. She has been honored as one of Fortune’s 50 Most Powerful Women in American Business for the last six years and was recognized by Modern Healthcare as one of the Top 25 Women in Healthcare.

“I am very happy to be joining Novavax at such an exciting time,” said Ms. Boudreaux. “I look forward to helping the company achieve its goal to develop and deliver safe and effective vaccines to improve global heath.”

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.

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MONDAY - 7/6/15

Novavax, Inc. (NVAX)

11.16 Up 0.28(2.57%) 4:00PM EDT

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TUESDAY - 7/ 7/ 2015

Novavax, Inc. (NVAX) 

11.35 Up 0.19(1.75%) 4:00PM EDT 

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NOVAVAX 

12.43 Up 0.35(2.85%) 4:00PM EDT

After Hours : 12.45 Up 0.02 (0.16%) 7:57PM EDT

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Novavax Gains as Ebola Vaccine Shows Human Immune Response 

by Doni Bloomfield 

July 21, 2015 — 8:20 AM EDT Updated on July 21, 2015 — 9:37 AM EDT

Novavax Inc.’s Ebola vaccine helped healthy people develop an immune response against the deadly virus in an early trial. The shares rose.

In a randomized study compared against a placebo, the vaccine pushed participants’ immune systems to build up antibodies to fight Ebola when combined with a supplement to boost production of the proteins, according to Greg Glenn, Novavax’s head of research.

“We have a very, very robust immune response,” Glenn said by phone. Monkeys who exhibited the same response to the vaccine “were completely protected” from Ebola. Novavax presented a study about the effect of the vaccine on primates in March.

Novavax rose 4.7 percent to $13.01 at 9:33 a.m. in New York. Its shares have more than doubled this year, valuing the company at $3.33 billion as of Monday’s close.

Ebola ravaged West Africa beginning in early 2014, killing more than 11,000 people. While the disease has fallen off sharply, stubborn pockets persist, with 30 new confirmed cases in the week ended July 12. Several potential vaccines -- from companies including GlaxoSmithKline Plc, Merck & Co. and NewLink Genetics Corp. -- are being tested on humans.

The Novavax study also found that its vaccine was “well-tolerated” and safe, Glenn said, with minor side effects including headaches. The trial involved 230 healthy Australian adults.
Novavax, which has its headquarters in Gaithersburg, Maryland, is also working on vaccines for respiratory syncytial virus, or RSV, as well as influenzas and the Middle East Respiratory Syndrome coronavirus, according to its website.

www.bloomberg.com/news/articles/2015-07-21/novavax-ebola-vaccine-shows-human-immune-response-in-early-trial?cmpid=yhoo

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Novavax Announces Positive Data From Phase 2 Trial of Quadrivalent Seasonal Influenza VLP

GAITHERSBURG, Md., July 30, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services under the Company’s contract with HHS-BARDA (HHSO100201100012C). The trial demonstrated that the Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research (CBER) criteria for accelerated approval.

CONTINUED:  ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArticle_print&ID=2072913

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Gaithersburg biotech expands into new research facility, preps for last phase of drug trials...


www.bizjournals.com/washington/blog/2015/06/gaithersburg-biotech-expands-into-new-research.html

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