dothedd
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NOVAVAX
May 6, 2014 14:50:31 GMT -5
Post by dothedd on May 6, 2014 14:50:31 GMT -5
Maryland Biotech Firm Developing MERS Vaccine April 30, 2014
The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) arrived in the U.S. last week but Gaithersburg, Md.-based Novavax has already developed a vaccine for the virus that is showing good results in animal testing. The Centers for Disease Control and Prevention confirmed at least one case of MERS in the U.S., in Indiana. While it's not something to panic about yet, the virus is serious, killing a little less than a third of people infected so vaccine developments may be important very soon.
According to the study, published in Vaccine, the way Novavax used its nanoparticle vaccine technology to come up with a way to treat newly emergent diseases. MERS appeared rather abruptly in the Middle East just a couple of years ago, making it a good example of the kind of diseases Novavax is aiming at.
"Our protein nanoparticle vaccine technology is proving to have the potential to respond rapidly to emerging viruses such as MERS-CoV, said Gale Smith, Novavax's VP of Vaccine Development in a release. "Novavax will continue to evaluate this technology to produce highly immunogenic nanoparticles for coronavirus, influenza, and other human disease pathogens with the potential for pandemic and sustained human to human transmission."
Don't be surprised if you've never heard of MERS until recently. Much like SARS did a decade ago, MERS popped up on the Arabian Peninsula seemingly out of nowhere. The current theory is that it mutated from a virus that only infected animals (camels are the most popular suspect) to a disease capable of infecting and even killing people. In fact it's actually killing people more quickly than SARS ever did although not spreading nearly as fast.
According to the World Health Organization, of the close to 350 people who have been confirmed as infected, 107 people have died from it. That's why the CDC has already put up a lot of information about MERS, despite it's so far very limited impact in the U.S.
"We’ve anticipated MERS reaching the US, and we’ve prepared for and are taking swift action," said CDC Director Tom Frieden in a release. "We can break the chain of transmission in this case through focused efforts here and abroad."
Novavax is hardly alone in trying to treat the disease. The Saudi Arabian Health Ministry announced last month that five pharmaceutical companies had partnered with it to create a vaccine that they hope will be ready in a few months. Novavax's vaccine will probably take longer to get vetted for use in people but may play a part in preventing future infections. Efforts are also being made to target infected camels and ideally remove the possibility of more infections that way.
Read More: DC Tech, news, biotech, vaccine, MERS, Novavax
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dothedd
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NOVAVAX
May 6, 2014 15:38:25 GMT -5
Post by dothedd on May 6, 2014 15:38:25 GMT -5
GAITHERSBURG, Md., May 6, 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 the appointment of Sven Andreasson to the position of Senior Vice President, Corporate Development, effective June 2, 2014. Mr. Andreasson will be responsible for identifying, prioritizing and evaluating new strategic opportunities that leverage the company's core strengths and growth initiatives.
Mr. Andreasson brings to Novavax a long history of experience in biopharmaceutical operations, executive management and strategic development from his many years in the industry. From 2012 to 2013 he served as the Chief Executive Officer of Isconova AB in Uppsala, Sweden, a leading international vaccine adjuvant company acquired by Novavax in 2013, currently operating as Novavax AB. Prior to his role at Isconova AB, Mr. Andreasson served as the Chief Executive Officer of Beta-Cell NV in Brussels, Belgium from 2008 to 2012 and as Chief Executive Officer of Active Biotech AB in Lund, Sweden from 1999 to 2008. Mr. Andreasson spent a number of years in roles inside Pharmacia Corporation including: President of Pharmacia SA, France, President of KabiPharmacia International and President of Pharmacia Arzneimittel GmbH, Germany.
"My first serious interactions with Sven occurred during our negotiations to acquire Isconova AB. I was immediately impressed with him as a pragmatic and thoughtful business professional. It became readily apparent to me that Novavax would benefit from his extensive vaccine and pharmaceutical industry experience and insight," said Stan Erck, President and CEO of Novavax. "I am very excited to have someone with Sven's experience help me and the entire management team to evaluate organic and non-organic opportunities to build this business and increase shareholder value."
Mr. Andreasson stated, "Novavax has an impressive pipeline and a remarkably talented and experienced team of professionals. Novavax' successful clinical trial data over recent months underscore its potential to develop into a major vaccine player. With today's strong platform as a base, we will systematically evaluate promising new growth possibilities. I look forward to joining the team of Novavax."
About Novavax
Novavax, Inc. (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 nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2013, and filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read company filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and the company undertakes no obligation to update or revise any of the statements. The company's business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contact: Barclay A. Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000
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dothedd
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NOVAVAX
May 7, 2014 22:35:38 GMT -5
Post by dothedd on May 7, 2014 22:35:38 GMT -5
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dothedd
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Post by dothedd on May 8, 2014 7:04:39 GMT -5
NOVAVAX
ANALYST COVERAGE Firm Analyst
FBR Capital Markets - William Tanner, Ph.D. Ladenburg Thalmann - Kevin DeGeeter MLV & Co. - Vernon Bernardino Piper Jaffray & Co. - Edward A. Tenthoff Wedbush Securities - Gregory Wade, Ph.D.
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dothedd
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Post by dothedd on May 8, 2014 7:11:20 GMT -5
LATEST PUBLICATIONS
SCIENTIFIC
Respiratory Syncytial Virus Fusion Glycoprotein Expressed in Insect Cells Form Protein Nanoparticles That Induce Protective Immunity in Cotton Rats. PLOS ONE, Smith, Gale, et al. Intranasal Vaccination with 1918 Influenza Virus-Like Particles Protects Mice and Ferrets from Lethal 1918 and H5N1 Influenza Virus Challenge. Journal of Virology, Perrone, Lucy A., et al. Cross-Clade Protective Immune Responses to Influenza Viruses with H5N1 HA and NA Elicited by an Influenza Virus-Like Particle. PLOS ONE, Bright, Rick A., et al.
VACCINES
Purified coronavirus spike protein nanoparticles induce coronavirus neutralizing antibodies in mice Vaccine, Smith, Gale, et al. A Recombinant Viruslike Particle Influenza A (H7N9) Vaccine The New England Journal of Medicine, Fries, Louis, et al. Rapid Manufacture and Release of a GMP Batch of Avian Influenza A(H7N9) Virus-Like Particle Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology BioProcessing Journal, Hahn, Timothy J. et al. Journal Link Development of influenza H7N9 virus like particle (VLP) vaccine: Homologous A/Anhui/1/2013 (H7N9) protection and heterologous A/chicken/Jalisco/CPA1/2012 (H7N3) cross-protection in vaccinated mice challenged with H7N9 virus Vaccine, Smith, Gale, et al. Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine Vaccine, Glenn, Gregory M., et al. H5N1 Virus-Like Particle Vaccine Elicits Cross-Reactive Neutralizing Antibodies That Preferentially Bind to the Oligomeric Form of Influenza Virus Hemagglutinin in Humans. Journal of Virology Khurana, Surender, et al. Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico. Vaccine, López-Macías, Constantino, et al. Influenza virus-like particle can accommodate multiple subtypes of hemagglutinin and protect from multiple influenza types and subtypes. Vaccine, Pushko, Peter, et al.
ADJUVANTS
Immune enhancing properties of the novel Matrix-M™ adjuvant leads to potentiated immune responses to an influenza vaccine in mice. doi: 10.1016/j.vaccine.2013.01.039. [Epub ahead of print] Sofia E. Magnusson, Jenny M. Reimer, Karin H. Karlsson, Lena Lilja, Karin Lövgren Bengtsson, Linda Stertman.
Matrix-M™ Adjuvant Induces Local Recruitment, Activation and Maturation of Central Immune Cells in Absence of Antigen. PLoS ONE 7(7): e41451. doi:10.1371/journal.pone.0041451 Jenny M. Reimer, Karin H. Karlsson, Karin Lövgren-Bengtsson, Sofia E. Magnusson, Alexis Fuentes, Linda Stertman. High-throughput proteomic screening identifies Chlamydia trachomatis antigens that are capable of eliciting T cell and antibody responses that provide protection against vaginal challenge. Vaccine 30 (2012) 4387-4393 Michele D. Picard, Kenya Prince Cohane, Todd M. Gierahn, Darren E. Higgins, Jessica Baker Flechtner T-helper 1 cells elicited by H5N1 vaccination predict seroprotection. J Infect Dis. 2012 Jul 15;206(2):158-66. Epub 2012 May 2 Pedersen G.K., Madhun A.S., Breakwell L., Hoschler K., Sjursen H., Pathirana R.D., Goudsmit J., Cox R.J. Iscom technology-based Matrix M™ adjuvant: success in future vaccines relies on formulation. Vaccines 10(4), 401-403 (2011) Lövgren Bengtsson K, Morein B, Osterhaus ADME.Expert Rev. A novel guinea pig model of Chlamydia trachomatis genital tract infection. Vaccine 29 (2011) 5994-6001 Marien I. de Jongea, Sander A.S. Keizera, Hicham M. el Moussaouia, Lieke van Dorstena, Rima Azzawia, Hanneke I. van Zuilekoma, Patricia P.W. Petersa, Fred J.H. van Opzeelandc, Laura van Dijka, Rob Nieuwlandb, Henriëtte W.M. Roosenboom-Theunissenb, Mieke P. Vrijenhoekb, Isolde Debyserd, Pierre J.M. Verweije, Wilbert G.F. van Duijnhovene, Johannes F. van den Boscha, Piet J.M. Nuijtena Intramuscular Matrix-M-adjuvanted virosomal H5N1 vaccine induces high frequencies of multifunctional Th1 CD4+ cells and strong antibody responses in mice. Vaccine, 2009 Dec 9;27(52):7367-76 Madhun AS, Haaheim LR, Nilsen MV, Cox RJ.
Matrix-M adjuvanted virosomal H5N1 vaccine confers protection against lethal viral challenge in a murine model. Influenza Other Respi Viruses. 2011 May 9. doi: 10.1111/j.1750-2659.2011.00256.x. Pedersen G, Major D, Roseby S, Wood J, Madhun AS, Cox RJ. Antibody and T-cell responses to a virosomal adjuvanted H9N2 avian influenza vaccine: impact of distinct additional adjuvants. Vaccine, 2008 Jul 4;26(29-30):3640-6 Radosevic K, Rodriguez A, Mintardjo R, Tax D, Bengtsson KL, Thompson C, Zambon M, Weverling GJ, Uytdehaag F, Goudsmit J. Chlamydia muridarum T-cell antigens formulated with the adjuvant DDA/TDB induce immunity against infection that correlates with a high frequency of gamma interferon (IFN-gamma)/tumor necrosis factor alpha and IFN-gamma/interleukin-17 double-positive CD4+ T cells. Infection and Immunity, 2010 May;78(5):2272-82 Yu H, Jiang X, Shen C, Karunakaran KP, Jiang J, Rosin NL, Brunham RC. Vaccination of horses against strangles using recombinant antigens from Streptococcus equi. Vaccine, 2007 May 4;25(18):3629-35 Waller A, Flock M, Smith K, Robinson C, Mitchell Z, Karlström A, Lannergård J, Bergman R, Guss B, Flock JI. Duration of immunity induced by an equine influenza and tetanus combination vaccine formulation adjuvanted with ISCOM-Matrix. Vaccine, 2010 Oct 8;28(43):6989-96 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ. The first safe inactivated equine influenza vaccine formulation adjuvanted with ISCOM-Matrix that closes the immunity gap. Vaccine, 2009 Sep 4;27(40):5530-7 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ. Nasal immunization with plasmid DNA encoding P6 protein and immunostimulatory complexes elicits nontypable Haemophilus influenzae-specific long-term mucosal immune responses in teh nasopharynx. Vaccine, 2011 Feb 24; 29(10):1881-90 Satoru Kodama, Takashi Hirano, Kenji Noda, Shingo Umemoto, Masashi Suzuki Vaccination of dogs with six different candidate leishmaniasis vaccines composed of a chimerical recombinant protein containing ribosomal and histone protein epitopes in combination with different adjuvants. Vaccine, 2009 Jul 16; 27(33):4439-46 J. Poot, L.H.M. Janssen, T.J. van Kasteren- Westerneng, K.H.A. van der Hekjden-Liefkens, V.E.J.C. Schijns, A. Heckeroth Immune response to Neospora caninuim negative antigens formulated with immune stimulating complexes in calves. Vet. Parasitol, 2011 Feb 10;175(3-4):245-51 D.P. Moore, I.Echaide, A.E. Verna, M.R. Leunda, A. Cano, S. Pereyra, P.I. Zamorano, A.C. Odeón, C.M. Campero
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dothedd
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Post by dothedd on May 8, 2014 7:19:40 GMT -5
HIGHLIGHTS FROM THE CONFERENCE CALL
Revenue:Our influenza contract with HHS BARDA, along with its access to $97 million in funding was extended beyond the original termination date of February 2014. We also announced the continuation of our RSV maternal immunization partnership with PATH that Greg mentioned earlier. And both of these alliances bring valuable development resources in sight, experience and non-dilutive sources of capital to fund our lead programs."
$112.8M in the bank and "We expect our quarterly cash usage to be considerably lower over the foreseeable future." In other words, look for some pretty large Q2 and Q3 revenue numbers as they collect the remaining $50M froim BARDA and miletsone payments from PATH. That revenue will more than cover the cash burn of $20M and put money in the bank.
Parnterships:
"We remain committed to the idea that bringing in large pharma partners at this stage is not to our benefit or our investor's benefit for a couple of reasons. One is we think we've done a really good job of developing the RSV vaccine candidate into multiple indications, elderly, kids and/or at least heading toward pediatrics and maternal immunization.
"We lead in this product and we lead the industry in this product and we want to maintain that lead -- through to licensure. And so we're not interested in partnering. And then of course, the economics, we want to maintain the economics for Nova, 100% of the economics for Novavax for the time being. We think it's a really important vaccine, perhaps, one of the -- perhaps, the biggest vaccine -- new vaccine to be introduced in the foreseeable future. And we are confident that the data that we've shown gives a lot of confidence that the vaccine will be protected. So we think we've de-risked the program to a degree and we've got to get into Phase III and beyond"
We've got to start thinking commercially about how to introduce these products, what other companies or products might be compatible with our future developments.
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dothedd
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Post by dothedd on May 8, 2014 9:28:18 GMT -5
Novavax: Promising Pipeline And Stable Revenue Add To Upside 1. Novavax has a strong clinical pipeline with multiple vaccines that have great potential.
2. The company aims to establish approaches in order to better prepare for and more effectively respond to fast-spreading infections.
3. Novavax's annual revenue grew 62-fold over the last five years; its revenue grew 92% in 4Q13. For full-year 2014, revenue is expected to grow 77.7%.
The recently extended HHS BARDA contract provides a stable revenue source for the company.
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dothedd
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Post by dothedd on May 8, 2014 9:36:42 GMT -5
CLICK ON THE LINK and then CLICK ON THE GRAPH TO ENLARGE IT TO MAKE IT MORE EASILY READ!static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766531509687326-Michael-Webb_origin.pngNovavax: Big Pharma Wants RSV Bad In Lazard's own words through the aforementioned William Tanner:
Novavax RSV-F vaccine is potentially one of the most under appreciated assets in the industry.
While that may be true for industry leaders and the larger investing public outside of Seeking Alpha, it hasn't been true for readers here who have been apprised of the enormous potential value of this asset in several stories including my last two iterations providing RSV insights.
Big pharma has been trying for years to perfect an RSV vaccine but with no success. You can see some of the big names who have thrown up their hands in frustration including Novartis and Merck from the graphic below provided by Novavax' partner, PATH.
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dothedd
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NOVAVAX
May 8, 2014 13:39:51 GMT -5
Post by dothedd on May 8, 2014 13:39:51 GMT -5
Conference Call - May 7, 2014
Novavax management will host its quarterly conference call today at 4:30 p.m. EDT. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website.
A replay of the conference call will be available starting at 7:30 p.m. on May 7, 2014 until midnight June 7, 2014. To access the replay by telephone, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 34845350. The replay will also be available as a webcast and can be found on the "Investor Info"/"Events" on the Novavax website.
GAITHERSBURG, Md., May 7, 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 reported its financial results for the first quarter ended March 31, 2014.
Novavax Corporate Highlights
Year-to-date 2014 Achievements:
Delivered positive top-line data from a dose-confirmatory Phase 2 clinical trial of its RSV F-protein vaccine candidate in 720 women of childbearing age, showing: Vaccine candidate was well-tolerated with no vaccine-related serious adverse events Highest immune responses observed with a single dose of vaccine combined with aluminum phosphate adjuvant Palivizumab-like antibodies exceeded levels observed in previous trials, and High levels of antibodies developed within 14 days after immunization and persisted over 91-day observation period; Initiated a U.S. Phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with Matrix-M(TM), targeted to enroll 610 healthy adult subjects between 18 and 64 years old, under the company's HHS BARDA contract; Published data in Vaccine demonstrating that an investigational vaccine candidate developed by Novavax against recently emerged Middle East Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory studies, adding further evidence of the power and potential of Novavax' recombinant nanoparticle vaccine technology; Demonstrated commitment to alliance management through extension of HHS BARDA contract for development of seasonal and pandemic influenza vaccines and continuation of RSV vaccine partnership on maternal immunization with PATH -- both collaborations bring valuable development resources, insight and experience, along with non-dilutive sources of capital funding; and Expanded Management team with appointment of John Trizzino, Senior Vice President, Commercial Operations, Cindy Oliver as Senior Vice President, Process Development, and Sven Andreasson as Senior Vice President, Corporate Development.
2014 Anticipated Events:
Release of top-line data from recently initiated Phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second half of 2014; Initiate Phase 2 clinical trial of its RSV F-protein vaccine candidate for protection of infants via maternal immunization in pregnant women in fourth quarter of 2014; Initiate Phase 2 clinical trial of its quadrivalent VLP seasonal influenza vaccine in the fourth quarter of 2014; and Initiate Phase 1 combination RSV/seasonal influenza clinical trial and Phase 1 pediatric RSV clinical trial, both in late 2014 or early 2015.
"Following the substantial progress in our RSV and influenza vaccine development programs in 2013, I am delighted with our accomplishments in the first quarter of 2014. Based on this first quarter activity, I continue to believe that 2014 represents greater potential accomplishments across our entire pipeline than we have ever had in our company's history," said Stan Erck, president and CEO of Novavax. "Our recently announced top-line data from the Phase 2 clinical trial in women of child bearing age gives us flexibility in the development of our RSV F vaccine candidate, not just for a maternal immunization strategy, but across all potential populations impacted by RSV."
Financial Results for the First Quarter March 31, 2014
In connection with its acquisition on July 31, 2013, Novavax AB's operations have been included in the company's consolidated results of operations and financial position as of the acquisition date. Novavax reported a net loss of $13.8 million, or $0.07 per share, for the first quarter of 2014, compared to a net loss of $10.0 million, or $0.07 per share, for the first quarter of 2013.
Novavax revenue in the first quarter of 2014 increased 95% to $7.5 million as compared to $3.8 million for the same period in 2013. The increase in revenue was primarily due to the higher level of activity in the first quarter of 2014 associated with the company's Phase 1/2 clinical trial using its H7N9 candidate and Matrix-M adjuvant and preliminary manufacturing work for its Phase 2 seasonal clinical trial under the HHS BARDA contract and the PATH amendment to support the company's Phase 2 clinical trial in women of childbearing age.
Research and development expenses increased 57% to $14.5 million in the first quarter of 2014, compared to $9.3 million for the same period in 2013, primarily as a result of higher employee-related costs tied to continued growth in support of the Company's RSV and influenza vaccine programs, as well as Novavax AB research and development expenses. General and administrative expenses increased 50% to $4.3 million in the first quarter of 2014 as compared to $2.9 million for the same period in 2013, resulting from higher professional fees and employee-related costs, as well as Novavax AB general and administrative expenses.
As of March 31, 2014, the company had $112.8 million in cash and cash equivalents and investments compared to $133.1 million as of December 31, 2013. Net cash used in operating activities for the first quarter of 2014 was $20.4 million compared to $10.6 million for the same period in 2013. The increase in cash usage from the prior year was primarily due to higher research and development spending, including the company's RSV clinical trial and higher employee-related costs, as well as timing of customer and vendor payments.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 p.m. EDT. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website.
A replay of the conference call will be available starting at 7:30 p.m. on May 7, 2014 until midnight June 7, 2014. To access the replay by telephone, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 34845350. The replay will also be available as a webcast and can be found on the "Investor Info"/"Events" on the Novavax website.
About Novavax
Novavax, Inc. (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 nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com
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dothedd
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NOVAVAX
May 9, 2014 12:03:24 GMT -5
Post by dothedd on May 9, 2014 12:03:24 GMT -5
MERS Vaccine Developers Prepared for 'Pandemic of Disastrous Proportions' It was no coincidence that Gaithersburg, Md.-based Novavax already had a Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine in development well before the first case arrived in the U.S. last week. Companies like Novavax are always on the lookout for the next possible pandemic disease and ways to combat it, including MERS.
"MERS is worrisome," said Gregory Glenn, senior vice president for research and development at Novavax. "Emergent diseases are worrisome because they are not predictable."
Emergent diseases like MERS can make it necessary to quickly create large amounts of vaccine for an entirely new virus, which is where Novavx's technology comes into play.
"We have an eye on the world and if we see something new we can develop vaccines for it in large quantities," Glenn said.
Glenn has been involved in vaccine development for a quarter of a century and has seen a lot of viruses come and go in that time. While there's not yet been anything even close to level of the influenza pandemic of the early 20th century in that time, it's very smart for scientists and government officials to plan ahead for seriously dangerous and contagious diseases.
"[Scientists] presume there will be another pandemic of disastrous proportions," he said.
Novavax is actually under a contract with the federal government to prepare for possible pandemics. It has a $187 million Health and Human Services deal to develop a pandemic flu vaccine, something that could be necessary at any time.
MERS isn't exactly like the seasonal flu but along with being more of an unknown since it first appeared a couple of years ago, it's also proven fairly deadly, with 30 percent of reported cases ending in death. While so far not as contagious as SARS or other viruses, the fact is that it could mutate to becoming more contagious and more deadly at any point. It was a mutation that made it possible for humans to catch it all, letting it leap from its previous common host, camels.
Novavax's MERS vaccine is showing good results in animal testing and in an emergency could get out to the general public very quickly under special FDA protocols rather than the far slower if surer method used for medicine more normally.
"It would have to come out quickly in that case," Glenn said. "Otherwise you'd just be immunizing the grandchildren of survivors."
Novavax is also taking a look at treating the camels as a way of stopping MERS from spreading to humans at all. Vaccines designed for horses will have some application there, Glenn said. Hopefully MERS will end up being just another cautionary tale of diseases to keep an eye on like so many other viruses, in which case Glenn and Novavax will start on preparing to create vaccines for whatever they think might be the next dangerous disease.
"There's always going to be another one coming," Glenn said.
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dothedd
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NOVAVAX
May 9, 2014 16:34:38 GMT -5
Post by dothedd on May 9, 2014 16:34:38 GMT -5
Friday 5 9 14
MARKET WATCH
Analysts Recommendations CURRENT: BUY 5 5 5
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dothedd
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NOVAVAX
May 15, 2014 12:28:20 GMT -5
Post by dothedd on May 15, 2014 12:28:20 GMT -5
THANK YOU "BG" ...
"""Bucket List 2014 - Revised with latest info"
1) Extension of PATH partnership - CHECK 2) Starting of Pandemic H7N9 flu w/ Matrix-M phase 1/2 trial for adult AND elderly- CHECK 4) Good top line results in RSV Phase IIb trial for women 5) Completion of H7N9 Phase 1 trial 6) Completion of RSV Phase 1 trial for Elderly 7) Completion of RSV Phase IIb trial for women 8) Completion of RSV reproductive toxicity study 9) Starting RSV Pediatrics Phase 1 trial 10) Starting RSV in pregnant women Phase 2b trial 11) Good Pandemic H7N9 w/ Matrix-M flu Phase 1/2 trial top line data 12) BARDA picks up 2nd half of contract 13) Collection of $3MM from seasonal flu IND 14) Starting of Quad Seasonal Flu phase 2b trial in young adults 15) Starting RSV/Flu combo "Respiratory Vaccine" Phase 1 trial
------------------------------------Jackpot Scenarios *) Stockpile Order for H7N9 *) Possible new BARDA contract or NIH funding for MERS/H5N1
------------------------------------Nice to haves *) Any trial improvements in India (Rabies, trivalent flu, malaria, etc.)"""
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dothedd
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NOVAVAX
May 15, 2014 14:46:19 GMT -5
Post by dothedd on May 15, 2014 14:46:19 GMT -5
Novavax: A Unique Opportunity May. 15, 2014 3:06 PM ET About: Novavax, Inc. (NVAX) Disclosure: I am long NVAX. Summary
Predictable Regulatory Approvals and Novel Financing -Equates to Low Risk and High Returns. Significant profit opportunity in 3 to 18 months.
Recent RSV clinical results achieved dramatic breakthroughs in efficacy and safety. Federal and Private, NGO investments provide independent votes of confidence. Pandemic Flu and emerging MERS threats put Novavax at the vanguard of protecting global health from emerging pandemics.
It's not often that you can invest in a small emerging biotech and not feel like you are venturing out onto a small thin ledge a hundred stories above the earth. The risk is tremendous, but and it's a big but, if everything goes right, so are the rewards. Novavax (NVAX) is the first biotech investment I have discovered in 20 years to effectively contradict this long held investment reality. There are four streams of information supporting this conclusion: 1) Novel funding secured for all major development programs; 2) Novavax's Respiratory Syncytial Virus (RSV) vaccine is a successful breakthrough product in a market that the pharmaceutical industry has been trying to crack for 55 years; 3) Positive results in both Seasonal and Pandemic Influenza programs; 4) Novavax is poised to become the primary emerging-disease, bio-shield, for the entire world as evidenced by their rapid response to the Middle East Respiratory Syndrome (MERS). This article closely examines the multiple unique elements, highlighting Novavax's clinical development approach, scientific advancements and novel funding resources, all of which "de-risks" the entire development platform. All of these various elements combine to produce a synergistic program assuring future success.
1) Novel Funding i.e., Free Money - It does not get any more novel than that!
In 1999 I was a member of a deal-team that produced a co-development agreement between Trimeris Pharmaceuticals and F. Hoffmann-La Roche AG. The drug was an antiviral with the brand name of Fuzeon. There was nothing unusual about the terms of this deal, then or now. Roche agreed to pay 50% of all development expenses in the United States and all development cost in foreign markets outside of the US that Roche chose to enter. In return, Trimeris would receive 50% of all income derived from US sales and greatly reduced royalty payments from all foreign sales.
Novavax's Influenza manufacturing and clinical development programs are fully funded by the US government through the Biomedical Advanced Research and Development Authority (BARDA). The government's rationale for investing $179 million in Novavax's flu program was to enable Health and Human Services (HHS) to obtain the future capability of expeditiously implementing a very rapid-response to any emerging influenza pandemic. Novavax currently offers the most effective vaccine product, produced in the shortest amount of time, to accomplish this stated goal. This is obviously a very strong vote of confidence from the federal government, who, after all, will eventually be in control of the company's regulatory approval. If this sounds naively optimistic, keep in mind that FDA is an agency within the Department of Health and Human Services.
More importantly for Novavax and unlike the Trimeris/Roche example cited above, there are no royalties or income sharing provisions encumbering this funding. This provides a very unusual, free clinical development program for Novavax's seasonal influenza pipeline.
This is so unusual for a development stage biotech that I am going to repeat it. The government is not a profit participant when the FDA approves future influenza programs, either seasonal or pandemic, for marketing. The magnitude of this last statement is hard to appreciate until you put it into the following context. What would Novavax's share price do tomorrow if they were to announce a co-development deal with Roche or Novartis? It would obviously go up dramatically even though the reality of the situation would be that they just cut in half all future income. Novavax has achieved the best of both worlds, obtained full funding for it's influenza program with no income sharing.
Novavax's other major clinical development project is Respiratory Syncytial Virus (RSV). There is a very similar funding story emerging on this front as well. The non-profit, Program for Appropriate Technology in Health (PATH), has to date, contributed $2 million dollars to the RSV program and can elect to contribute 50% of Novavax's future external RSV clinical development cost. Novavax has made a commitment to make the product affordable and available in low-resource countries while retaining all rights to global commercialization. Novavax/Path Press Release Again, there are no provisions within the PATH funding agreement regarding any future profit sharing even though the potential exists for a development like deal funding level.
2) Respiratory Syncytial Virus (RSV): A Huge Un-Tapped Market.
RSV has been an untapped multi-billion dollar, target of opportunity for the pharmaceutical industry for 55 years. The RSV virus was discovered in 1956 and attempts at producing a vaccine have been continuous since 1960. With decades of research and many failed attempts, there is still no RSV specific vaccines or effective targeted antiviral agents in the form of small molecules or drugs in the market.
It is estimated that there are 64 million cases of RSV disease worldwide each year, resulting in 160,000 deaths. All cause mortality rates, i.e., secondary afflictions stemming from the primary RSV infection, approaches 600,000 deaths a year. An example would be a bacterial infection resulting in pneumonia, which was secondary to the primary RSV infection. In the U.S., RSV causes as many as 172,000 annual hospitalizations among children younger than 5 years of age, with the vast majority of these occurring in infants less than six months of age. By 18 months of age, 87% of all children have developed RSV specific antibodies and by 3 years of age, virtually all children have been exposed. Compared with influenza, RSV causes 19 times more deaths in children younger than 1 year. RSV is also the second leading cause of viral death in elderly individuals. Sources: Advances in the Treatment of RSV, PATH
The global market for an effective RSV vaccine targeting pregnant mothers, infants/children, immune compromised and elderly, is estimated to be between $9 and $10 billion.
PATH produced the competitive landscape slide shown below. It identifies the majority of the current 55 RSV development projects. This very large number of development projects underscores both the unmet human need as well as the richness of the opportunity. PATH receives Bill and Melinda Gates foundation donations and together, those foundations have positioned an RSV vaccine as one of its highest priorities, determining that this specific disease intervention could make a dramatic difference in preventing morbidity and mortality in the world. Both of these foundations have all-star, world class, scientific review committees. Investments in Novavax by these foundations through PATH represents a strong vote of confidence that Novavax symbolizes both the most cost effective and promising therapeutic pathway for them to foster. This slide also underscores that Novavax clearly leads the race to regulatory approval in all development categories with the exception of the live attenuated strategies being utilized by Medimmune. Live attenuated RSV vaccines have historically been prohibitively problematic upon a live infection challenge after the vaccine administration. Results of Medimmune's (MEDI-559) Phase II RSV vaccine trial can be found here. Two bullet points should underscore the inferiority of MEDI-559. Adverse Events occurred in 67% MEDI-559 of vaccine recipients. The most common adverse event was upper respiratory tract infections occurring in 35% of recipients. A higher incidence of medically attended lower respiratory illness within 28 days after dosing occurred in the MEDI-559 arm.
boooyaaaah.........
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dothedd
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NOVAVAX
May 19, 2014 20:30:16 GMT -5
Post by dothedd on May 19, 2014 20:30:16 GMT -5
Anti-MERS trial vaccine raises hopes The University of Maryland, in partnership with the US-based Novavax pharmaceutical company, has developed a vaccine that appears to effectively fight the MERS coronavirus in mice. Meanwhile, four deaths and six new cases of MERS were reported on Monday, bringing the death toll to 173 since September 2012.
The fatalities were reported in Jeddah, Makkah, Riyadh and Tabuk and were from among cases that had been previously diagnosed.
Newly diagnosed patients, meanwhile, are all men from Riyadh, Jeddah, Madinah and Taif. The announcement of the “investigational vaccine” was published in Vaccine magazine on April 13 this year.
Novavax has claimed that the vaccine is also a “candidate” against the SARS coronavirus, which killed 775 people and infected 8,000 in 2003.
Stanley C. Erck, president and chief executive officer of Novavax, said the company is communicating with various parties, including the US government to try the vaccine against the coronavirus. “But nothing yet materialized with the Kingdom of Saudi Arabia,” he said.
Erck said that more funding is needed for research and that there would have to be close cooperation with the health authorities in affected countries.
Matthew Frieman, assistant professor and supervisor of the study at Maryland University, said the vaccine showed effective results by increasing the antibodies resisting the virus in mice.
The statement published on Novavax's website said that the vaccine would target the S protein that links the virus with the body's cells. Once the protein is dismantled the process would provide prevention and protection against the virus.
Image Link: www.arabnews.com/sites/default/files/imagecache/galleryformatter_slide/6569261450396096.jpg
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dothedd
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NOVAVAX
May 19, 2014 20:36:05 GMT -5
Post by dothedd on May 19, 2014 20:36:05 GMT -5
MERS cases drop in KSA; alarm over medics becoming carriers mers_health workers.jpg
Foreign nurses are seen at the premises of the King Fahd Hospital in the city of Hofuf in the Eastern Province in this June 16, 2013, file photo. It was in Hofuf where the first outbreak of MERS infections sparked a global alarm. Since then, at least 163 deaths from MERS have been reported in Saudi Arabia. (AFP)
Published — Sunday 18 May 2014
NEW YORK: The biggest risk that Middle East Respiratory Syndrome (MERS) will become a global epidemic, ironically, may lie with globe-trotting health care workers.
“This is how MERS might spread around the world,” said infectious disease expert Dr. Amesh Adalja of the University of Pittsburgh Medical Center.
It can take five to 14 days for someone infected with MERS to show symptoms, more than enough time for a contagious person to fly to the other side of the world without being detectable.
Health care workers “are at extremely high risk of contracting MERS compared to the general public,” Adalja said.
The threat has attracted new attention with the confirmation of the first two MERS cases in the United States. Both are health care workers who fell ill shortly after leaving their work in Saudi hospitals and boarding planes bound west.
About one-third of the MERS cases treated in hospitals in Jeddah were health care workers, according to the World Health Organization (WHO).
The Ministry of Health's counted 529 MERS infections since September 2012, of which 168 patients died as of May 17, 2014.
Despite the risk, few of the health care workers now in, or planning to go to, Saudi Arabia are having second thoughts about working there, according to nurses, doctors and recruiters interviewed by Reuters.
Michelle Tatro, 28, leaves next week for the kingdom, where she will work as an open-heart-surgery nurse. Tatro, who typically does 13-week stints at hospitals around the United States, said her family had sent her articles about MERS, but she wasn’t worried.
“I was so glad to get this job,” she told Reuters. “Travel is my number one passion.” So far, international health authorities have not publicly expressed concern about the flow of expatriate medical workers to and from Saudi Arabia.
“There is not much public health authorities or border agents can do,” said infectious disease expert Dr. Michael Osterholm of the University of Minnesota. “Sure, they can ask people, ‘did you work in a health care facility in Saudi Arabia,’ but if the answer is yes, then what?“
Health care workers are best placed to understand the MERS risk, Osterholm said, and “there should be a heightened awareness among them of possible MERS symptoms.”
Neither the Centers for Disease Control and Prevention nor the Department of Homeland Security responded to questions about whether they were considering monitoring health care workers returning to the United States.
Soaring demand In the last few years, the number of expatriates working in Saudi Arabia has soared, said Suleiman Arabie, managing director of Houston, Texas-based recruiting firm SA International, with thousands now working in the kingdom.
The Saudi government is building hundreds of hospitals and offering private companies interest-free loans to help build new facilities.
About 15 percent of physicians working in the Kingdom are American or European, and some 40 percent of nurses are Filipino or Malaysian, according to estimates by recruiters and people who have worked in hospitals there.
The majority of US-trained medical staff are on one- or two-year contracts, which results in significant churn as workers rotate in and out of Saudi medical facilities.
Arabie’s firm is trying to fill positions at two dozen medical facilities in Saudi Arabia for pulmonologists, a director of nursing, a chief of physiotherapy and scores more.
Doctors in lucrative, in-demand specialties such as cardiology and oncology can make $1 million for a two-year contract, recruiters said.
Nurses’ pay depends on their home country, with those from the United States and Canada earning around $60,000 a year while those from the Philippines get about $12,000, recruiters said. That typically comes with free transportation home, housing, and 10 weeks of paid vacation each year. For Americans, any income under about $100,000 earned abroad is tax-free, adding to the appeal of a Saudi posting.
Undaunted One Filipino nurse, who spoke anonymously so as not to hurt her job prospects, told Reuters that she was “willing to go to Saudi Arabia because I don’t get enough pay here.” In a private hospital in Manila, she made 800 pesos (about $18) a day.
“I know the risks abroad but I’d rather take it than stay here,” she said. “I am not worried about MERS virus. I know how to take care of myself and I have the proper training.”
None of Arabie’s potential candidates “have expressed any concern” about MERS. Only one of the hundreds of professionals placed by Toronto-based medical staffing firm Helen Ziegler & Associates Inc. decided to return to the United States because of MERS, it said, and one decided not to accept a job in Jeddah she had been hired for.
Recruitment agencies in Manila have also continued to send nurses to the kingdom since the MERS outbreak, said Hans Leo Cacdac, the head of the Philippine Overseas Employment Administration. The government advises that returning workers be screened for MERS, Labor and Employment Secretary Rosalinda Baldoz said this week.
Expat health care workers now working in Saudi Arabia feel confident local authorities are taking the necessary steps to combat the spread of MERS in hospitals.
“Just today they came and put up giant posters in our hospital on MERS,” said Dr. Taher Kagalwala, a pediatrician originally from Mumbai who works at Al Moweh General Hospital in a town about 120 miles from Taif city in western Saudi Arabia.
“I have not heard of or seen any health care workers looking to leave their jobs or return to their countries because of the MERS panic. If it was happening, there would have been gossip very soon.”
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dothedd
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Post by dothedd on May 20, 2014 10:07:29 GMT -5
Most Active Biotech Stocks: Novavax, Inc. (NASDAQ:NVAX), Mast Therapeutics Inc (NYSEMKT:MSTX), Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)Published On: Tue, May 20th, 2014 Novavax, Inc. (NASDAQ:NVAX) [Trend Analysis] is the main biotech investment that some experts have discovered in 20 years to effectively contradict this long held investment realism. Novavax’s scientific as well as business development teams are clearly looking to situation of Novavax as a major force in the field of vaccines for the near term and far into the distant future. By making this numerous positive confluent components, it becomes obvious that there are a very strong, competent as well as talented scientific and management teams in guiding Novavax.
Novavax, Inc. (NASDAQ:NVAX) after opening at $4.17 hit its intraday high price of $4.63 moreover then finished at $4.58 by shares raised 10.36%. At Wall Street for latest quarter, the consensus average estimates of street for the revenue are $8.74M, at the same time as 4 experts forecast $10.36M revenues for the next three months of 2014. As took noticed on the firm sales growth (year/est), it is calculated 147.50% in Current Qtr. and for next quarter was forecasted 115.70%.
www.emarketsdaily.com/most-active-biotech-stocks-novavax-inc-nasdaqnvax-mast-therapeutics-inc-nysemktmstx-ariad-pharmaceuticals-inc-nasdaqaria/1810417/
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dothedd
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Post by dothedd on May 20, 2014 23:10:41 GMT -5
In Case Of MERS Emergency - Break Glass, Buy Novavax
May. 20, 2014 2:01 PM ET
Summary
Only Novavax has the science and production facilities to appropriately respond to an emerging MERS threat.
MERS infections are increasing dramatically, with 300 new infections reported by WHO in the last few weeks.
Investment opportunity is directly related to the number of new infections, and thus can be tracked and measured.
Has the Middle East respiratory syndrome coronavirus, or MERS-CoV, risen to the threat level where it will be declared a pandemic threat in the near future, resulting in government contracts to produce vaccines to protect US citizens? Alarmed public health officials around the world are monitoring a dramatic increase in infections of this deadly new virus.
The recent surge in infections and deaths are significant. Even more concerning are the number of new MERS cases, which seem to be growing exponentially.
As dramatic as the recent "Virology Down Under" graphic above is, the numbers have already doubled since its publication. The World Health Organization (WHO) reported on May 16th that globally, 614 laboratory-confirmed cases of infection with MERS-CoV have officially been reported, including 181 deaths. That makes the current fatality rate 29%. Historical tracking data is available from WHO here. These numbers may be dramatically under-reported. It appears likely that there are significant cases of MERS in Africa that have not been captured in this reporting process. The National Institute for Communicable Diseases (NICD) is attempting to provide guidance to accurately capture this missing piece of the puzzle.
On Friday, May 17th, the Centers for Disease Control (CDC) conducted a public briefing via a telephone conference call. This briefing was primarily focused on the three cases of MERS that have been identified here in the US. Two individuals worked in the Arabian Peninsula and traveled back to the US after becoming infected. One case was human-to-human transmission between two businessmen, where the only physical contact was one handshake. Here is CNN's coverage of that incident
On May the 17th, The Motley Fool published an article describing three companies as possible beneficiaries of potential government contracts to prepare the US against an infectious disease outbreak of MERS here and abroad - "Could These 3 Biotechs Help Fight the MERS Virus?"
The companies that were the focus of this article were:
1) Inovio Pharmaceuticals (INO)
2) Novavax (NVAX)
3) Nanoviricides (Not Publicly Traded)
Of these three companies, only one, Novavax, has published data demonstrating that its MERS vaccine candidate blocked infection in laboratory studies.
Only Novavax has three full-scale vaccine production facilities that enable it to immediately start producing a vaccine now.
It appears that only one company is being contacted by both US and foreign governmental health agencies for information on the timeline for producing and providing a vaccine - Novavax.
During Novavax's May 7th Earnings Call (Transcript), Stanley C. Erck, CEO, responded to an analyst's question regarding MERS inquiries to the company.
Yes, we're getting -- there's a lot of interest -- we're starting to get inbounds from a variety of different sources, all the way to the Middle East and so it's not clear what the direction is going to be, right now. All of this surge in activity has been in the last -- just in the last few weeks. And so it's a clear problem. We have a potential solution, and we were [engaged] early enough on this to actually have published data on it, so we'll see.
Significant contracts could be disclosed much sooner than anyone following normal regulatory patterns and timeline would expect. One possible short-term intervention mentioned on this same conference call would be to provide the human vaccine product already produced by Novavax, and utilize it in the zoonotic source, camels, to stop the spread of the virus. The following statement by Mr. Erck was in response to a question by Gregory Wade of Wedbush Securities, who wanted to know what exactly a MERS medical countermeasure would look like.
From our point of view, it could be a vaccine that could be used, actually the medical countermeasure could be to prevent -- to vaccinate animals would be one way. The other would be a human vaccine, and those are the 2 that are currently on our table right now, same vaccine.
Novavax's CEO was also asked if he believed that a mass vaccination of people would be potentially acceptable, based upon the limited number of individuals currently infected? His response was:
Yes, and that actually depends on which way or which direction the disease goes. And then it might be in the geographic area.
WHO says the spread of the MERS virus isn't yet a worldwide health emergency.
No US governmental agency has declared that the MERS outbreaks have reached the threshold of an epidemic.
Although there have been no emergency declarations, many agencies in many countries are closely monitoring the situation and preparing for just such an outcome.
As an investor, I will be monitoring the WHO site that reports the most current data on new MERS infections. You can find that information here, reported by the Global Alert and Response (GAR) group. GAR is the WHO's integrated global alert and response system for epidemics and other public health emergencies.
The CDC also has a dedicated site for reporting the most recent US information on MERS.
Other US agencies involved in researching and monitoring MERS are NIAID, which also leads an interagency working group on MERS-CoV therapeutics. Other federal government agencies represented within this group include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), and the Biomedical Advanced Research and Development Authority (BARDA). Novavax's Influenza program has received $179 million in funding to-date from BARDA.
If the infection rate continues on its current trajectory, then governmental intervention will become inevitable. Governmental, in this case, is not limited to the US, as the name implies this virus emerged from and is causing the most infections and deaths in the Middle East, at least so far.
Last week, I published a detailed look at Novavax's regulatory approval prospects, and I would like to ascribe its recent price gains to that article. A much more likely scenario is many investors are seeing Novavax as a play on the potential of an emerging MERS pandemic. Track the rate at which infections are increasing using the links provided in this article, and invest accordingly.
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dothedd
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NOVAVAX
May 21, 2014 9:01:07 GMT -5
Post by dothedd on May 21, 2014 9:01:07 GMT -5
Novavax Inc.'s stock finished Monday's session 10.36% higher at $4.58. A total of 5.55 million shares were traded, which was above its three months average volume of 4.62 million shares. The stock moved between $4.14 and $4.63 during the session. Novavax Inc.'s stock has advanced 7.76% in the previous three trading sessions and 13.65% in the last one month. However, from the beginning of 2014, the stock has declined 10.55%. The S&P 500 Health Care Sector Index mapped a gain of 0.64% during the trading session, and the same charted up 0.19% in the last three months. The company's shares are trading above their 50-day and 200-day moving averages. Moreover, the stock's 50-day moving average of $4.45 is greater than its 200-day moving average of $4.14. Novavax Inc.'s stock has an RSI of 47.31. Sign up today to read free research on NVAX at: www.investor-edge.com/2755-NVAX-20May2014.pdf
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dothedd
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NOVAVAX
Aug 15, 2014 12:58:46 GMT -5
Post by dothedd on Aug 15, 2014 12:58:46 GMT -5
Thursday, August 7, 2014 Novavax to Present at the Wedbush Securities Life Sciences Management Access ConferenceGlobeNewswire( (Thu, Aug 7) Wednesday, August 6, 2014
Novavax Reports Second-Quarter 2014 Financial ResultsGlobeNewswire( (Wed, Aug 6) Wednesday, July 30, 2014
Novavax to Host Conference Call to Discuss Second Quarter 2014 Financial Results on August 6, 2014GlobeNewswire( (Wed, Jul 30) Monday, June 23, 2014
Novavax Recognized as One of The Washington Post's Top WorkplacesGlobeNewswire( (Mon, Jun 23) Thursday, June 19, 2014
Novavax Announces Management PromotionsGlobeNewswire( (Thu, Jun 19) Wednesday, June 18, 2014
Long-Time Novavax Board Member Jack Marsh Assumes Role of Director EmeritusGlobeNewswire( (Wed, Jun 18) Wednesday, June 11, 2014
Novavax Announces Exercise of Option to Purchase Additional Shares and Closing of Public OfferingGlobeNewswire( (Wed, Jun 11) Thursday, June 5, 2014
Novavax Prices Public Offering of Common StockGlobeNewswire( (Thu, Jun 5) Wednesday, June 4, 2014
Novavax Announces Proposed Public Offering of Common StockGlobeNewswire( (Wed, Jun 4) Monday, June 2, 2014
Novavax to Present at the Jefferies 2014 Global Healthcare ConferenceGlobeNewswire( (Mon, Jun 2) Thursday, September 12, 2013
Genocea Reports Positive Initial Phase 1/2a Results for GEN-003, its Pioneering Therapeutic Vaccine Candidate for the Treatment of Herpes Simplex Virus-2 (HSV-2), at ICAAC 2013PR Newswire( (Thu, Sep 12) Wednesday, August 28, 2013
Genocea Biosciences Selected To Present Late-Breaking Oral Presentation At ICAAC 2013PR Newswire( (Wed, Aug 28)
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dothedd
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NOVAVAX
Aug 25, 2014 15:51:59 GMT -5
Post by dothedd on Aug 25, 2014 15:51:59 GMT -5
Novavax, Inc. (NVAX) -NasdaqGS 4.68 Up 0.15(3.31%) 4:00PM EDT
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dothedd
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NOVAVAX
Aug 28, 2014 16:19:02 GMT -5
Post by dothedd on Aug 28, 2014 16:19:02 GMT -5
4.62 Down 0.11(2.33%) 4:00PM EDT After Hours : 4.6191 Down 0.00 (0.02%) 4:28PM
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dothedd
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Sept 15, 2014 11:20:50 GMT -5
Post by dothedd on Sept 15, 2014 11:20:50 GMT -5
Novavax to Host an Analyst and Investor Meeting with Webcast
Tuesday, September 23, 2014, from 9:00 a.m. - 11:00 a.m. (EDT) Senior management will conduct a series of presentations to update analysts and investors as to the company's recombinant nano-particle vaccine technology, its RSV F-protein vaccine candidate and its influenza vaccine candidates.
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dothedd
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Post by dothedd on Sept 15, 2014 12:01:40 GMT -5
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dothedd
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Post by dothedd on Sept 16, 2014 17:46:39 GMT -5
Novavax Initiates Phase 2 Clinical Trial of RSV F-Protein Nanoparticle Vaccine Candidate in Healthy Third-Trimester Pregnant Women Novavax, Inc. 2 hours ago
GAITHERSBURG, Md., Sept. 16, 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 enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy women in the third trimester of pregnancy.
The purpose of this study is to evaluate the safety and immunogenicity of the RSV F Vaccine, in women in their third trimester of pregnancy. The trial will also assess the impact of maternal immunization on infant safety and RSV-specific antibody levels through one year and six months of life, respectively.
"Initiation of this trial represents a watershed event for Novavax and the entire vaccine industry," said Stan Erck, President and CEO of Novavax. "Our ability to deliver, on our timeline, the initiation of this landmark clinical trial is a measure of the credibility of our technology, the potential of our vaccine and most importantly, the commitment and experience of our people."
finance.yahoo.com/news/novavax-initiates-phase-2-clinical-200500627.html
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dothedd
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Post by dothedd on Oct 2, 2014 9:34:25 GMT -5
Biotech Stocks Grab Intensions- Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA), MannKind Corporation (NASDAQ:MNKD), Novavax, Inc. (NASDAQ:NVAX)
Novavax, Inc. (NASDAQ:NVAX) [Trend Analysis] dropped in last session as investor looks caused that how effetely firm will recently declared that optimistic top-line data from a dose-ranging, randomized, observer-blinded, placebo-controlled phase I/II study on its H7N9 avian influenza virus-like particle (VLP) vaccine candidate, H7N9 VLP. Novavax, Inc. (NASDAQ:NVAX) slump -1.20%, closing the day at $4.12, after wavering among $4.02 to $4.18 during the trading session. Its net profit margin in lasted declared quarter was 216.30% as compared to -248.54% in previous year in same year. The stock has a 52-week high price of $6.95 and its 52-week low price was $2.68. club.ino.com/trend/?symb=NASDAQ_NVAX&a_aid=emarkets&a_bid=7c63a09b
The whole article is a GOOD READ!
www.emarketsdaily.com/biotech-stocks-grab-intensions-ariad-pharmaceuticals-inc-nasdaqaria-mannkind-corporation-nasdaqmnkd-novavax-inc-nasdaqnvax/1818933/
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dothedd
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NOVAVAX
Oct 2, 2014 10:44:22 GMT -5
Post by dothedd on Oct 2, 2014 10:44:22 GMT -5
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dothedd
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NOVAVAX
Oct 2, 2014 10:45:21 GMT -5
Post by dothedd on Oct 2, 2014 10:45:21 GMT -5
NOVAVAX
The long term trend has been DOWN since Apr 7th, 2014 at 3.940000 intermediate term down... The intermediate term trend has been DOWN since Sep 15th, 2014 at 4.560000 short term down...
The short term trend has been DOWN since Oct 1st, 2014 at 4.080000...
THE SHORTS ARE IN CONTROL...AGAIN!
I ADDED....
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dothedd
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Oct 2, 2014 10:49:24 GMT -5
Post by dothedd on Oct 2, 2014 10:49:24 GMT -5
Novavax, Inc. (NVAX) 3.960 -0.16 : - )
Novavax' H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM) Delivers Positive Phase 1/2 Clinical Data 9/23/14 8:33am
Benzinga's Top Initiations 9/19/14 9:09am
UPDATE: Wedbush Assumes Coverage On Noravax, Inc. As Stock Gears Up For Catalyst-Rich 2015 9/19/14 7:53am
Wedbush Initiates Novavax At Outperform 9/19/14 7:43am
Benzinga's Top #PreMarket Gainers 8/13/14 8:08am
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dothedd
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NOVAVAX
Oct 2, 2014 18:45:26 GMT -5
Post by dothedd on Oct 2, 2014 18:45:26 GMT -5
NOVAVAX PPS
10/2/14 4.05 Down 0.07(1.70%) 4:00PM EDT After Hours : 4.0508 Up 0.00 (0.02%) 4:30PM EST
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Oct 3, 2014 12:27:12 GMT -5
Post by dothedd on Oct 3, 2014 12:27:12 GMT -5
NVAX PPS
Friday 10/3/14
4.0818 0.0318(0.79%) 1:01PM EDT 4.0851 0.0351(0.87%) 1:03PM EDT 4.10 0.05(1.11%) 1:13PM EDT 4.10 0.05(1.23%) 1:26PM EDT 4.10 0.05(1.23%) 1:36PM EDT 4.11 0.06(1.48%) 4:00PM EDT
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