NOVAVAX

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Novavax: Analyst Cory Kasimov Provides Update
From The J.P. Morgan Healthcare Conference 

January 15, 2015 11:50 AM EDT by Editor Jason Cohen in Exclusively Published • 
J.P. Morgan’s healthcare analyst Cory Kasimov weighed in today with a review on Novavax (NASDAQ:NVAX), straight from the 2015 J.P. Morgan Healthcare Conference in San Francisco. The analyst rates the stock an Overweight with a $7 price target.

Kasimov observed, “CEO Stanley Erck largely reviewed the company’s 6 clinical programs underway and emphasized the substantial unmet need in RSV, seasonal influenza, and emerging viruses ahead of what we expect to be an important year for NVAX with data readouts expected from all 6 programs.”

The following bullets contain some highlights from the presentation:

Large Ph2 RSV trial in elderly is underway; efficacy data will inform powering and primary endpoint of Ph3 trial; NVAX thinks this could be first licensed product.
On Ebola, NVAX believes longer-term value derived from this program (currently unclear how economic benefit gets to shareholders).

NVAX believes it has several advantages over other Ebola programs: current vaccines only have stability at -80 degrees, NVAX’s vaccine is based on current circulating strain (other are based on strains 30 yrs old), the co can make millions of doses in 90 days (others could make 1M doses in a yr).

Plans to start Ph1 Ebola trial in the next 3 wks with data in 3Q; safety,
immunogenicity and animal model data (confident in non-human primate data) can be used for regulatory package.

According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Cory Kasimov has a total average return of 12.3% and a 56.1% success rate. Kasimov has a 34.6% average return when recommending NVAX, and is ranked #511 out of 3426 analysts.

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Novavax continues upward march ...

Novavax (NVAX +9.1%) is up on double normal volume today clearing consolidation at $6. Investors appear impressed with the company's presentation yesterday at JPM15.

CEO Stan Erck is scheduled to appear on CNBC's Mad Money with Jim Cramer this evening.

NVAX price at time of publication: $6.37. Check NVAX price now »
Was this email forwarded to you? Learn more about Seeking Alpha Alerts here »

Focus Articles on NVAX

Cash-Rich Novavax Has Upside Potential by Value Insight
Novavax: Expect Chain Reaction In Stock Price From Multiple Catalytic Events by 

Reasons To Accumulate Shares Of Novavax by Intrepid Investor
More News on NVAX

Novavax RSV vaccine candidate Fast Track'd Nov 20, 10:34 AM ET (Seeking Alpha)
Midday movers: Arista Networks, eBay, Humana & More Jun 6, 12:17 PM ET (CNBC)

Lightning Round: Under Armour, M&T Bank & More Apr 23, 6:44 PM ET (CNBC)
Press Releases on NVAX

Novavax Announces Management Promotion (GlobeNewswire)
Novavax to Present at the 33rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire)

Novavax to Present at the 26th Annual Piper Jaffray Healthcare Conference (GlobeNewswire)

Related Articles on NVAX
Will Biotech Fire On All Cylinders In 2015? by Life Sciences Report
Is Novavax Really Worth 25 Times As Much As Vical? by Intrepid Investor
Unveiled House Spending Bill Bullish For Ebola Stocks by Matthew Finston

StockTalk on NVAX: NVAX StockTalk | Twitter NVAX | Twitter $NVAX | NVAX Instablogs


Transcripts on NVAX
Novavax's (NVAX) CEO Stanley Erck on Q3 2014 Results - Earnings Call Transcript by SA Transcripts
Novavax (NVAX) Q3 2014 Results - Earnings Call Webcast by SA Transcripts
Novavax's (NVAX) CEO Stanley Erck on Q2 2014 Results - Earnings Call Transcript by SA Transcripts

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NOVAVAX CEO Stan Erck is scheduled to appear on CNBC's Mad Money with Jim Cramer!!!!

 ...this evening at 6PM...EST ...

one-half hour from NOW

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Biotech Stocks Analysis – Celgene Corporation (CELG), Gilead Sciences, Inc. (GILD), Regado Biosciences Inc (RGDO), Novavax, Inc. (NVAX)


www.wsnewspublishers.com/health/biotech-stocks-analysis-celgene-corporation-celg-gilead-sciences-inc-gild-regado-biosciences-inc-rgdo-novavax-inc-nvax/

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ALL ABOUT NOVAVAX!

... 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.)

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MarketClub’s Trade Triangles for NVAX 

long term up The long term trend has been UP since Oct 16th, 2014 at 5.070000
intermediate term up The intermediate term trend has been UP since Dec 8th, 2014 at 5.530000
short term up The short term trend has been UP since Jan 16th, 2015 at 6.575000

Smart Scan Analysis for NVAX
Based on a pre-defined weighted trend formula for chart analysis, NVAX scored +100 on a scale from -100 (strong downtrend) to +100 (strong uptrend).

6.90 0.09(1.32%) 9:51AM EST
6.92 0.11(1.61%) 9:54AM EST
7.06 0.25(3.67%)

Day's Range: 6.87 - 7.11
52wk Range: 3.34 - 7.11
Volume:
10:17AM EST

Day's Range: 6.87 - 7.09
52wk Range: 3.34 - 7.09
Volume:


Day's Range: 6.87 - 7.11
52wk Range: 3.34 - 7.11
Volume: 2,439,207
7.01 0.20(2.94%) 10:19AM EST
6.99 0.18(2.72%) 10:20AM EST 2,495,019

7.14 Up 0.33(4.85%) 10:47AM EST

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Novavax, Inc. (NASDAQ:NVAX) Extends Its Confidence At Biotech Industry With- Illumina Inc. (NASDAQ:ILMN), Intrexon Corporation (NYSE:XON) 

Posted by: Devon Leftovich 3 hours ago

LINK:
www.streetwisereport.com/novavax-inc-nasdaqnvax-extends-its-confidence-at-biotech-industry-with-illumina-inc-nasdaqilmn-intrexon-corporation-nysexon/19038/

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FULL VIDEO...Published on Jan 15, 2015

Cramer's interview with the President of Novavax....




NVAX TRANSACTION DATES OF OFFICERS BEGINNING 2015

Date Filed: Feb 3, 2015 5:05PM  Transaction Date: Jan 31, 2015 
PHILLIPS BARCLAY A SVP, Chief Financial Officer Purchased $19,125 (8,388 shares @ $2.28)

Date Filed: Feb 3, 2015 5:06PM  Transaction Date: Jan 31, 2015 
Glenn Gregory M SVP, Research and Development Purchased $1,974 (866 shares @ $2.28)

Date Filed: Feb 3, 2015 5:07PM  Transaction Date: Jan 31, 2015 
Wilson Russell P SVP, Business Development Purchased $11,514 (5,050 shares @ $2.28)

Date Filed: Feb 3, 2015 5:07PM  Transaction Date: Jan 31, 2015 
Hahn Timothy Jon SVP, Manufacturing Purchased $21,270 (9,329 shares @ $2.28)

Date Filed: Feb 3, 2015 5:08PM  Transaction Date: Jan 31, 2015 
Herrmann John A III SVP, General Counsel Purchased $22,501 (9,869 shares @ $2.28)

Date Filed: Feb 3, 2015 5:09PM  Transaction Date: Jan 31, 2015 
Trizzino John SVP, Commercial Operations Purchased $23,998 (6,611 shares @ $3.63)


2/24/15 
Only one company which has tested vaccine in place and yes! it is NVAX...... Buy as much as you can. Today's price is a gift!

CLINICAL TRIALS

Novavax NCT02078674: A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

Novavax NCT01960686: RSV F Dose-Ranging Study in Women

Novavax NCT01897701: A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

Novavax NCT01709019: A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated

Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age

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Trends & Responses 2015: NovavaxRead more at:

Singapore: Emerging viruses and those with pandemic potential, such as Middle East Respiratory Syndrome (MERS) and Ebola, were an incredibly important global public health issue this past year. Using recombinant nanoparticle technology, Novavax has demonstrated both the ability and agility to rapidly respond to these emerging threats. We announced the publication of significant preclinical data on a vaccine candidate to MERS in April of this year and the first Ebola vaccine candidate based on the 2014 Guinea Ebola strain in October.

These programs build on significant momentum from 2013, when we initiated a clinical trial of our H7N9 pandemic influenza vaccine candidate in humans a mere 91 days after the RNA sequence was made available. The encouraging data and speed with which it was obtained was significant enough to merit publication in the New England Journal of Medicine. We expect to initiate a Phase 1 clinical trial of the Ebola vaccine candidate in the first quarter of 2015. Novavax executed on a number of significant milestones in 2014. We announced the initiation of three key clinical trials of our RSV F-protein vaccine as well as the extension of our partnership with PATH, which partially supports the RSV program. In the second quarter of 2014, we announced data from a RSV F-protein Phase 2 clinical trial in 720 women of childbearing age, establishing a single dose formulation which demonstrated safety and the highest levels of antibodies seen in any previous study. This data formed the basis for dose selection for later trials. Data indicating the RSV F-protein vaccine is safe, potent, and elicits high levels of neutralizing antibodies was published in the journal Vaccine, suggesting that the vaccine provides protection against both homologous strain and heterologous strain viral challenges. Significantly, we received Fast Track Designation from the FDA for RSV F-protein vaccine for protection of infants via maternal immunization, which reflects the FDA's recognition of this important unmet medical need and their support for Novavax's novel approach. We also received an extension of our BARDA (Biomedical Advanced Research and Development Authority, US Department of Health and Human Services) contract, worth up to $167 million, through September 2016. This contract supports our seasonal and pandemic influenza programs. Finally, Novavax received Fast Track Designation from the FDA for our H7N9 vaccine candidate, underscoring the FDA's recognition of an urgent need for an H7N9 vaccine and the strength of Novavax's H7N9 virus-like particle vaccine candidate. 2015 represents a significant inflection point for Novavax. Respiratory syncytial virus (RSV) preys on the vulnerable, infants, children and the elderly, and is the major cause of hospitalizations of infants 0-12 months. Globally, RSV is the second-leading cause of infant mortality due to infectious disease behind only malaria. We expect to report data on three key clinical trials of our RSV F-protein vaccine in 2015: our maternal study in women in their third trimester of pregnancy to support the development of maternal immunization strategy for protection of infants 0-6 months, our pediatric study in children 6 months to 6 years of age and our study in the elderly over 60 years of age. We also plan to report data on a phase 2 clinical trial of our recombinant quadrivalent seasonal influenza vaccine candidate.

Together, these trials may position Novavax to initiate our first phase 3 clinical trial by the end of 2015, an important final step before receiving FDA approval for our vaccines. With the independent advancement our RSV vaccine and our seasonal influenza vaccine, we will take the opportunity to explore the combination of these two products into a broad seasonal respiratory vaccine with the initiation of a Phase 1 clinical trial in the first quarter of 2015. We are proud that we have added over 240 dedicated and talented employees to the Novavax team over the past three years. We look forward to 2015 as a year of continued growth as we advance to a late-stage company and beyond. While our recombinant protein nanoparticle technology allows us too rapidly respond to emerging threats, we remain focused on executing on a number important milestones including completing the three key clinical trials in our RSV program as well as our quadrivalent seasonal influenza vaccine. Positive results from these programs will position Novavax to potentially advance the development into a phase 3 pivotal study in the elderly in late 2015. We look forward to another exciting year for the industry. We expect the industry to continue innovate in an effort to create breakthrough products in virtually all fields.

- See more at: www.biospectrumasia.com/biospectrum/opinion/220216/trends-responses-2015-novavax

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 March 4, 2015: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Center Date Time Location
CBER March 4, 2015 8:30 a.m. to 3 p.m. DoubleTree Hotel by Hilton
8727 Colesville Road
Silver Spring, MD 20910

Agenda:

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee Meeting main page.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before February 18, 2015

Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 9, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 10, 2015.....


CONTINUED:
www.fda.gov/AdvisoryCommittees/ucm427596.htm

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Novavax, Inc. (NASDAQ:NVAX) has received a Strong Buy rating from First Call Corporation, a division of Thomson Reuters. The rating information was disclosed in the equity research recommendation.

Analysts from various Brokerage Firms have rated the company and commented on its price target. Novavax, Inc. (NASDAQ:NVAX): The stock price is expected to reach $ 9.75 in the short term. The number of analysts agreeing with this consensus is 6. The higher estimate for the short term price target is at $11 while the lower estimate is at $7. The standard deviation of the price stands at $1.41.

Novavax, Inc. (NASDAQ:NVAX) ended the day on a positive note gaining 0.14%. The day opened at $7.38 and the stock hit $7.44 on the upper end. However, intraday bearish pressure saw the price plummet to $7.14, at which some value buying and short covering came in. Closing higher after dropping to such lows only strengthens the counter. The stock last traded at $7.37 with 3,182,051 shares having exchanged hands. The 52-week peak value of the shares is $7.74 and the yearly low is $3.34. The company has a market cap of $1,758 million and there are 238,478,000 outstanding shares.

Novavax, Inc. (NASDAQ:NVAX) has a short ratio of 11.07. Higher the ratio, the more pressurized the stock will be, lower the ratio, lesser the duress on the stock. The short interest has seen a change of -6.7% in the past month. The 3-month change in short interest was measured at 0.12%. The ratio of monthly shorts to total outstanding shares stands at 0.137. The average daily volume for the last 20 days is 5,328,504 shares. The 20-day volume is 2.23% of the total shares outstanding. A low short ratio indicates marginal bearishness while a high short ratio represents excessive pessimism.

stafforddaily.com/first-call-rating-update-on-novavax-inc/321275/

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ENVIRONMENT
China on high alert over new bird flu cases
Authorities set to close live poultry markets in major cities over fears of deadly H7N9 bird flu virus.
29 Jan 2014 10:22 GMT


www.aljazeera.com/news/asia-pacific/2014/01/china-high-alert-over-new-bird-flu-cases-201412992057688355.html


A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
This study is ongoing, but not recruiting participants.
Sponsor:
Novavax
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT02078674
First received: March 3, 2014
Last updated: May 13, 2014
Last verified: May 2014
History of Changes

A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1
This study has been completed.
Sponsor:
Novavax
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT01897701
First received: July 9, 2013
Last updated: October 10, 2014
Last verified: October 2014
History of Changes

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Profit From The Cure For The Flu 

www.nasdaq.com/article/profit-from-the-cure-for-the-flu-cm438193

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Cramer's interview with the President of Novavax.... 

                                 ABOVE ...... FULL VIDEO...Published on Jan 15, 2015



NVAX TRANSACTION DATES OF OFFICERS BEGINNING 2015

Date Filed: Feb 3, 2015 5:05PM Transaction Date: Jan 31, 2015
PHILLIPS BARCLAY A SVP, Chief Financial Officer Purchased $19,125 (8,388 shares @ $2.28)

Date Filed: Feb 3, 2015 5:06PM Transaction Date: Jan 31, 2015
Glenn Gregory M SVP, Research and Development Purchased $1,974 (866 shares @ $2.28)

Date Filed: Feb 3, 2015 5:07PM Transaction Date: Jan 31, 2015
Wilson Russell P SVP, Business Development Purchased $11,514 (5,050 shares @ $2.28)

Date Filed: Feb 3, 2015 5:07PM Transaction Date: Jan 31, 2015
Hahn Timothy Jon SVP, Manufacturing Purchased $21,270 (9,329 shares @ $2.28)

Date Filed: Feb 3, 2015 5:08PM Transaction Date: Jan 31, 2015
Herrmann John A III SVP, General Counsel Purchased $22,501 (9,869 shares @ $2.28)

Date Filed: Feb 3, 2015 5:09PM Transaction Date: Jan 31, 2015
Trizzino John SVP, Commercial Operations Purchased $23,998 (6,611 shares @ $3.63)

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NOVAVAX 52 WEEK HIGH OCCURRED ON January 28 2015


Jan 28, 2015 7.90 8.06 7.61 7.65 5,821,400 7.65

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33rd Annual J.P. Morgan Healthcare Conference
San Francisco, CA
January 14, 2015
Presenter: Stanley Erck


Webcast: click here:

jpmorgan.metameetings.com/confbook/healthcare15/directlink.php?p=17086

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NVAX PRE MARKET!

7.98 Feb 5, 4:00PM EST
Pre-Market : 8.19 Up 0.21 (2.63%) 9:08AM EST

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PRESS RELEASE 

NOVAVAX TO PRESENT AT THE 33RD ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
GAITHERSBURG, Md., Jan. 7, 2015 (GLOBE NEWSWIRE) -- 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 Stanley C. Erck, President and CEO, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015 at 11:30 a.m. PT in San Francisco, CA at The Westin St. Francis Hotel.

A live webcast link for the presentation will be available via the company's website at www.novavax.com under Investor Info/Events.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases.

CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
Novavax logo

Novavax, Inc.

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Bio Processing Journal

bioprocessingjournal.com/J/Novavax/index.html#/0

bioprocessingjournal.com/J/Novavax/index.html#/2

bioprocessingjournal.com/J/Novavax/index.html#/4

bioprocessingjournal.com/J/Novavax/index.html#/6

bioprocessingjournal.com/J/Novavax/index.html#/8

bioprocessingjournal.com/J/Novavax/index.html#/10

bioprocessingjournal.com/J/Novavax/index.html#/12

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11 Hours Ago

Globe Newswire

PRESS RELEASES
Novavax Announces Initiation of Ebola Vaccine Phase 1 Clinical Trial Supported by Non-Human Primate Challenge Data and Documented Rapid Manufacturing Capabilities

Initiation of Enrollment of Phase 1 Clinical Trial of Ebola GP Vaccine
Non-Human Primate Challenge Data Signal Breakthrough in Ebola Vaccine Development
Rapid Manufacturing Process of Ebola GP Vaccine Published in BioProcessing Journal

GAITHERSBURG, Md., Feb. 12, 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 enrollment has begun in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™ (Ebola GP Vaccine) in healthy subjects. Novavax initiated the development of its Ebola GP Vaccine shortly after the publication of the genetic sequence of the 2014 Ebola Makona strain (previously referred to as the 2014 Ebola Guinea strain), which is responsible for the current Ebola epidemic in West Africa. In an expedited time-frame, from the publication of the Makona sequence in September 2014, Novavax has developed the vaccine, scaled-up GMP manufacturing, delivered positive results from multiple relevant animal models, including a non-human primate challenge study, and today initiated a Phase 1 clinical trial.

Stanley C. Erck, President and CEO said, "In less than 5 months, Novavax has validated its Ebola GP Vaccine with compelling animal data, including complete protection against a lethal Ebola challenge in non-human primates, leading to the initiation of this Phase 1 clinical trial. With our ongoing efforts to develop our vaccine against the A/H7N9 influenza strain, this is the second novel strain of an emerging virus with pandemic potential, for which Novavax has been able to construct and produce a vaccine, subsequently demonstrate immunogenicity in one or more relevant animal models, and initiate a clinical trial. Additionally, like our other recombinant vaccine candidates, our Ebola GP Vaccine can be rapidly scaled-up to produce millions of doses. Creating new vaccines in such an expeditious manner exemplifies Novavax' ability to respond to a variety of global infectious disease threats."

The Ebola GP Vaccine clinical trial, which is being conducted in Australia, is a randomized, observer-blinded, dose-ranging Phase 1 study to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M adjuvant, in 230 healthy adult subjects between 18 and 50 years of age. Each subject will receive two intramuscular injections, one each on study days 0 and 21. In addition to the trial's primary goal of evaluating safety in this population, the study will also evaluate immunogenicity as measured by concentrations of serum IgG antibodies to the Ebola Makona strain glycoprotein. Secondary study endpoints include epitope-specific immune responses to the Ebola GP antigen as measured by serum titers in a competitive ELISA assay using known-neutralizing monoclonal antibodies, as well as serum Ebola virus neutralizing antibody reciprocal titers.

The Phase 1 clinical trial initiation is supported by significant immunogenicity and efficacy data demonstrating that the Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates. Non-human primates received two injections of a 5µg dose of the Ebola GP Vaccine with the Matrix-M adjuvant, and were challenged with a lethal dose of Ebola virus. As expected, the challenge was lethal for the control animal whereas, in sharp contrast, 100% of the immunized animals were protected. Additionally, the Ebola GP Vaccine induced Ebola Makona strain GP antibody titers of 106 (ELISA EC90) after two doses and 104, after a single dose, both results well above the range reported to provide protection in non-human primate models and reported in recent Ebola Phase 1 clinical trials.

"The strong immune responses observed in our animal immunogenicity models and the protection observed in the non-human primate challenge models, confirm that our Ebola GP Vaccine is an important candidate for consideration. The use of a sequence reflecting the current circulating Makona strain of Ebola virus, along with the observed dose-sparing and enhanced antibody quality by the addition of our Matrix-M adjuvant, compelled the company to move to clinical testing," said Gregory Glenn, M.D., Senior Vice President, Research and Development. "Because of the unprecedented ongoing Ebola epidemic, and with more than 20 historical outbreaks of Ebola virus, Novavax believes there is an urgent need for a safe and effective licensed vaccine. Combined with the very promising recent data on our Ebola GP Vaccine, there is a clear rationale for moving this program forward."

The rapid progression to a Phase I clinical trial is further supported by Novavax' GMP manufacturing process, as documented in the February 10, 2015 online publication of BioProcessing Journal (available at novavax.com under "Publications & Presentations"). The article titled "Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology" details Novavax' manufacturing development process from genetic engineering of the 2014 Makona strain gene sequence through master seed preparation, qualification of analytical methods, and ultimately GMP manufacture with product release three months after project initiation.

About Ebola

Ebola virus, formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Five strains of Ebola virus have been identified, the most recent of which, the 2014 Makona strain, is associated with a case fatality rate of between 50 and 90%. There are currently no licensed immunological or therapeutic treatments proven to neutralize the virus, although a range of blood, immunological vaccine and drug therapies are under development.

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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BB Biotech AG files portfolio update


BB Biotech AG just filed a portfolio update (also known as a 13-F), dated February 11, 2015. The portfolio holdings are as of December 31, 2014.

BB Biotech AG reported adding to its positions of:
Theravance
Synageva BioPharma Corp.
Receptos, Inc.
Radius Bancorp Inc.
Puma Biotechnology Inc
Novavax
ImmunoGen
Halozyme Therapeutics
Gilead Sciences
Clovis Oncology


Day's Range: 8.24 - 8.49
52wk Range: 3.34 - 8.55
Volume: 3,177,909

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Novavax, Inc. (NVAX)
Median target price: $10 (17% upside)
Positive ratings: 100% of 8 analysts



$8.66 +0.26 | 3.10%
02/13/15 - 12:06:02 PM ET (BATS BZX Real-time Price)
Prev Close: 8.40
Day's Open: 8.40
Volume:2.61M
Avg Vol:4.63M
Shares Outstanding: 238.48M
Mkt Cap: 1.97B
Div: --
Div Yield: --
P/E: N/A
EPS:-0.31

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Analysts Ratings for NVAX
STRONG BUY....
Strong Buy 

YTD 41.65% 3-Mo60.31% 1-Yr46.85% 3-Yr522.22%


$8.57 +0.17 | 2.00%
02/13/15 - 12:13:15 PM ET (BATS BZX Real-time Price)

8.61 Up 0.21(2.51%) 12:57PM EST

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EST $NVAX  .... Cramer interviewing the CEO on tonight show.



Companies pushing Ebola vaccines through trials won't let up, says Novavax CEO
Feb 13, 2015, 5:00am EST

www.bizjournals.com/washington/blog/2015/02/companies-pushing-ebola-vaccines-through-trials.html?ana=yahoo

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Companies pushing Ebola vaccines through trials won't let up, says Novavax CEO 

Feb 13, 2015, 5:00am EST

Even with Ebola cases dropping dramatically and the U.S. announcing plans to end its related military assistance in west Africa, don't expect the U.S. companies racing to make new Ebola vaccines to let up.

That's what Stanley Erck, CEO of Gaithersburg vaccine company Novavax Inc., told me Thursday. He was speaking to me following news his company initiated a clinical trial on its own Ebola vaccine candidate.

"A lesson has been learned here," Erck said, referring to Ebola vaccine projects which stalled in the U.S. drug pipeline prior to the latest Ebola crisis. "I'd certainly think there will be funding to see this through licensure, as well as for stockpiles."

I was asking him about the likelihood Novavax (Nasdaq: NVAX) would ever make it to commercialization with this vaccine candidate. There are several other candidates further along in clinical trials, including one being developed by Johnson & Johnson (NYSE: JNJ), which are considered front-runners among Ebola vaccines candidates. Rockville-based contract research firm Optimal Research is performing J&J's clinical trial. The Gates Foundation-backed GAVI Alliance announced late last year it will commit as much as $390 million to support Ebola vaccines to stop the deadly outbreak in West Africa. The company has yet to bring a vaccine to the market.

"This outbreak has increased the level of visibility and importance of having a viable Ebola vaccine," Erck said.

The company sees a strong long-term market, he added, among at-risk African nations, health care workers and the military.

Novavax's most viable commercialization candidate is a vaccine in Phase 2 clinical trials for RSV, the most common cause of inflammation of the small airways in the lung and pneumonia in children less than a year old 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.

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NOVAVAX ANNOUNCES INITIATION OF EBOLA VACCINE PHASE 1 CLINICAL TRIAL SUPPORTED BY NON-HUMAN PRIMATE CHALLENGE DATA AND DOCUMENTED RAPID MANUFACTURING CAPABILITIES
Initiation of Enrollment of Phase 1 Clinical Trial of Ebola GP Vaccine

Non-Human Primate Challenge Data Signal Breakthrough in Ebola Vaccine Development

Rapid Manufacturing Process of Ebola GP Vaccine Published in BioProcessing Journal

GAITHERSBURG, Md., Feb. 12, 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 enrollment has begun in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™ (Ebola GP Vaccine) in healthy subjects. Novavax initiated the development of its Ebola GP Vaccine shortly after the publication of the genetic sequence of the 2014 Ebola Makona strain (previously referred to as the 2014 Ebola Guinea strain), which is responsible for the current Ebola epidemic in West Africa. In an expedited time-frame, from the publication of the Makona sequence in September 2014, Novavax has developed the vaccine, scaled-up GMP manufacturing, delivered positive results from multiple relevant animal models, including a non-human primate challenge study, and today initiated a Phase 1 clinical trial.

Stanley C. Erck, President and CEO said, "In less than 5 months, Novavax has validated its Ebola GP Vaccine with compelling animal data, including complete protection against a lethal Ebola challenge in non-human primates, leading to the initiation of this Phase 1 clinical trial. With our ongoing efforts to develop our vaccine against the A/H7N9 influenza strain, this is the second novel strain of an emerging virus with pandemic potential, for which Novavax has been able to construct and produce a vaccine, subsequently demonstrate immunogenicity in one or more relevant animal models, and initiate a clinical trial. Additionally, like our other recombinant vaccine candidates, our Ebola GP Vaccine can be rapidly scaled-up to produce millions of doses. Creating new vaccines in such an expeditious manner exemplifies Novavax' ability to respond to a variety of global infectious disease threats."

The Ebola GP Vaccine clinical trial, which is being conducted in Australia, is a randomized, observer-blinded, dose-ranging Phase 1 study to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M adjuvant, in 230 healthy adult subjects between 18 and 50 years of age. Each subject will receive two intramuscular injections, one each on study days 0 and 21. In addition to the trial's primary goal of evaluating safety in this population, the study will also evaluate immunogenicity as measured by concentrations of serum IgG antibodies to the Ebola Makona strain glycoprotein. Secondary study endpoints include epitope-specific immune responses to the Ebola GP antigen as measured by serum titers in a competitive ELISA assay using known-neutralizing monoclonal antibodies, as well as serum Ebola virus neutralizing antibody reciprocal titers.

The Phase 1 clinical trial initiation is supported by significant immunogenicity and efficacy data demonstrating that the Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates. Non-human primates received two injections of a 5µg dose of the Ebola GP Vaccine with the Matrix-M adjuvant, and were challenged with a lethal dose of Ebola virus. As expected, the challenge was lethal for the control animal whereas, in sharp contrast, 100% of the immunized animals were protected. Additionally, the Ebola GP Vaccine induced Ebola Makona strain GP antibody titers of 106 (ELISA EC90) after two doses and 104, after a single dose, both results well above the range reported to provide protection in non-human primate models and reported in recent Ebola Phase 1 clinical trials.

"The strong immune responses observed in our animal immunogenicity models and the protection observed in the non-human primate challenge models, confirm that our Ebola GP Vaccine is an important candidate for consideration. The use of a sequence reflecting the current circulating Makona strain of Ebola virus, along with the observed dose-sparing and enhanced antibody quality by the addition of our Matrix-M adjuvant, compelled the company to move to clinical testing," said Gregory Glenn, M.D., Senior Vice President, Research and Development. "Because of the unprecedented ongoing Ebola epidemic, and with more than 20 historical outbreaks of Ebola virus, Novavax believes there is an urgent need for a safe and effective licensed vaccine. Combined with the very promising recent data on our Ebola GP Vaccine, there is a clear rationale for moving this program forward."

The rapid progression to a Phase I clinical trial is further supported by Novavax' GMP manufacturing process, as documented in the February 10, 2015 online publication of BioProcessing Journal (available at novavax.com under "Publications & Presentations"). The article titled "Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology" details Novavax' manufacturing development process from genetic engineering of the 2014 Makona strain gene sequence through master seed preparation, qualification of analytical methods, and ultimately GMP manufacture with product release three months after project initiation.

About Ebola

Ebola virus, formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Five strains of Ebola virus have been identified, the most recent of which, the 2014 Makona strain, is associated with a case fatality rate of between 50 and 90%. There are currently no licensed immunological or therapeutic treatments proven to neutralize the virus, although a range of blood, immunological vaccine and drug therapies are under development.

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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Hutchinson Clinic to test new RSV vaccine 

UPDATED: 04:34 AM CST Feb 18, 2015

www.kwch.com/news/local-news/Hutchinson-Clinic-to-test-new-RSV-vaccine/31327124

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Further development of prevention, treatment options for RSV required 

Infectious Diseases in Children, February 2015
READ OR SUBMIT ARTICLE COMMENTS EMAIL PRINT
SAVE

According to the CDC, the majority of children in the US will have contracted a respiratory syncytial virus infection by their second birthday — a statistic so large it would seem almost routine. In most infants, respiratory syncytial virus causes mild, coldlike symptoms that subside in 1 to 2 weeks. For premature infants and children with special health care needs, however, respiratory syncytial virus represents a serious risk for infection that can cause pneumonia or bronchiolitis.

CONTINUED: www.healio.com/pediatrics/vaccine-preventable-diseases/news/print/infectious-diseases-in-children/%7B70a60488-deea-40f4-bad2-ea655acfc498%7D/further-development-of-prevention-treatment-options-for-rsv-required

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Published on FierceVaccines  

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.

www.novavax.com/download/file/Fierce%20Vaccines%20article(1).pdf

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NVAX -- Listen to presentation from JP Morgan conference. A lot of data coming out this year. jpmorgan.metameetings.com/confbook/healthcare15/directlink.php?p=17086