Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2175)

[DasTier666]

Novavax Announces Positive Top-Line Data From Phase 1 Ebola Vaccine Trial on WHO Teleconference
GAITHERSBURG, Md., July 21, 2015 (GLOBE NEWSWIRE)

Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™ as part of the World Health Organization’s (WHO) Fifth Teleconference on Ebola Vaccine Clinical Trials. The trial demonstrated that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with Novavax’ proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing.

The Ebola GP Vaccine clinical trial is a randomized, observer-blinded, dose-escalation trial to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M, in 230 healthy adults between 18 and 49 years of age. Participants received either one or two intramuscular injections ranging from 6.5µg to 50µg of antigen on study days 0 and 21. Immunogenicity was assessed at multiple time points including days 28 and 35.

The adjuvanted Ebola GP Vaccine was highly immunogenic at all dose levels. The adjuvanted two-dose regimens induced Ebola anti-GP antibody geometric mean responses between 45,000 and 70,000 ELISA units (GMEU), representing a 500 to 750-fold rise over baseline at day 35. The adjuvanted single dose vaccine regimen induced GMEU between 1700 and 3400, representing a 21 to 27-fold rise over baseline at day 35.

“We are pleased to have the opportunity to share these positive data with the WHO. Novavax’ recombinant nanoparticle technology and proprietary Matrix-M adjuvant differentiates our Ebola GP Vaccine. The Phase 1 clinical data show that our vaccine was well-tolerated and elicited very high Ebola antibody responses,” said Gregory Glenn, M.D., Senior Vice President, Research and Development. “These data, together with two positive challenge studies in non-human primates, suggest that the Ebola GP Vaccine would be protective in humans.”

Stanley C. Erck, President and CEO said, “These positive data represent the third time Novavax has leveraged the power of our platform technology to rapidly address an emerging threat. These Ebola GP Vaccine data, in combination with clinical data from our H7N9 VLP vaccine candidate and preclinical data from our vaccine candidate for Middle East Respiratory Syndrome coronavirus, provide additional validation of our nanoparticle vaccine platform. Our Ebola GP Vaccine, adjuvanted with Matrix-M, was highly immunogenic at low doses, allowing for dose-sparing. Further, our recombinant vaccines do not need to be shipped or stored frozen, a key consideration for a vaccine developed against a novel lethal virus with pandemic potential.”

Today’s Novavax presentation to the WHO can be accessed via the Presentations section of the Novavax website, www.novavax.com by close of business today.

http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…

[DasTier666]

Die Homepage bekam eine Auffrischung und Gail Boudreaux steigt mit ins Boot. Meiner Meinung nach sind das nicht unbedingt Zeichen für schlechte Ergebnisse.


gabs hierzu ne Meldung?

BARDA Contract

...In June 2015, the contract was increased by $7.7 million to allow for the recovery of additional costs under the contract relating to the settlement of indirect rates for fiscal years 2011 and 2012. This additional amount was recorded as revenue in the three months ended June 30, 2015 and payment was received in July 2015.
http://novavax.com/page/16/barda-contract

[DasTier666]

Citigroup Inc. Increases Novavax Price Target to $18.00 (NVAX)
Posted on July 9, 2015 by Justin Garson in Analyst Articles - US, Investing

Equities research analysts at Citigroup Inc. raised their target price on shares of Novavax (NASDAQ:NVAX) from $10.00 to $18.00 in a research note issued to investors on Thursday, AnalystRatings.Net reports. Citigroup Inc.’s price objective would suggest a potential upside of 64.99% from the company’s current price.

http://sleekmoney.com/citigroup-inc-increases-novavax-price-…

[DasTier666]

Gaithersburg biotech expands into new research facility, preps for last phase of drug trials
Jun 4, 2015, 3:41pm EDT

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

http://www.bizjournals.com/washington/blog/2015/06/gaithersb…

[DasTier666]

Why Novavax Shares Rocketed Higher By Nearly 25% in June

http://www.fool.com/investing/general/2015/07/07/why-novavax…

[DasTier666]

Novavax Presents New Data From Non-Human Primate Ebola Challenge at the 7th International Symposium on Filoviruses


GAITHERSBURG, Md., March 28, 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 Gale Smith, Ph.D., Vice President, Vaccine Development, will present, "Recombinant EBOV/Makona Glycoprotein (GP) Nanoparticle Vaccine Produced in Sf9 Insect Cells," at the 7th International Symposium on Filoviruses, Saturday, March 28, 2015 at 10:15 a.m. at the Washington Marriott Metro Center in Washington, D.C.

As part of his talk, Dr. Smith will present new data from a second non-human primate (NHP) study which was conducted by the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases (NIH-NIAID-DMID). In that study, animals received two injections of a 5µg dose of Novavax' Ebola GP Vaccine together with its proprietary Matrix-M adjuvant and were then challenged with a lethal dose of the Ebola virus. Similar to the previous NHP study, the challenge was lethal for the control animals, whereas the animals immunized with Novavax' EBOV GP Vaccine remain healthy 18 days post challenge.

"This data provides significant, independent confirmation that our Ebola GP Vaccine is safe and effective in providing protection in NHP models," said Dr. Smith. "Our vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates and this confirmatory data strongly supports the advancement of this program. Importantly, although we developed our Ebola GP Vaccine from the Makona strain, which is the strain responsible for the recent Ebola epidemic in West Africa, these primates were challenged with the Kikwit strain of Ebola, which suggests that our vaccine candidate may be protective across different variants of the virus."

Novavax is currently conducting a Phase 1 clinical trial of its Ebola GP Vaccine in healthy subjects. It expects top-line data from this trial in mid-2015.
http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…


evtl. gibt es am 12.05.15 noch Rückenwind, sollten diese Ergebnisse Beachtung finden

FDA panel to discuss Ebola vaccine development in May
Wed Mar 18, 2015 9:24am EDT


(Reuters) - The U.S. Food and Drug Administration said an advisory panel will discuss the development of Ebola vaccines, days after an American health worker was flown back after being tested positive for Ebola in Sierra Leone.

The federal health regulator would discuss the development of vaccines on May 12, it announced on its website on Wednesday.

Ebola has so far claimed about 10,000 lives in Sierra Leone, Liberia and Guinea. Only a handful of cases have been reported in the United States, Spain and Britain.
The resurgence of the virus last year prompted drugmakers from across the world to develop new treatments that are in different stages of studies.
Mapp Biopharmaceutical's ZMapp and a compound from Tekmira Pharmaceuticals Corp have so far shown they could cure non-human primates given injections of Ebola virus.
Other companies that are testing potential treatments for the deadly infection are GlaxoSmithKline, Sarepta Pharmaceuticals Inc, Novavax Inc, Merck & Co and Johnson & Johnson.

The World Health Organization said it will decide on mass vaccination against the virus in August.


(Reporting by Vidya L Nathan in Bengaluru; Editing by Don Sebastian)

http://www.reuters.com/article/2015/03/18/us-health-ebola-fd…

FDA Kalendereintrag
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm438627.htm

[DasTier666]

Antwort auf Beitrag Nr.: 49.421.576 von gutdrauf9 am 25.03.15 18:20:14

ja leider, hier der Rest

GAITHERSBURG, Md., March 26, 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 it has priced an underwritten public offering of 24,137,931 shares of common stock at a price to the public of $7.25 per share for gross proceeds of approximately $175 million. Novavax expects to receive net proceeds, after deducting the underwriting discount, of approximately $165 million from the offering. In connection with this offering, Novavax has granted the underwriters a 30-day option to purchase up to an additional 3,620,689 shares of its common stock. If the underwriters exercise this option in full, Novavax will have sold 27,758,620 shares of its common stock.
Novavax intends to use the net proceeds from this offering for the advancement of its lead vaccine candidates, including the preparation and potential initiation of Phase 3 clinical trials of its elderly RSV and maternal RSV programs, as well as its other clinical and preclinical research programs and general corporate purposes, including working capital, product development, manufacturing and process development expenditures and capital expenditures, as well as acquisitions and other strategic purposes. The offering is expected to close on or about March 31, 2015, subject to the satisfaction of customary closing conditions.
http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArtic…

hoffen wir mal, daß sie mit der Kohle die Phase III stemmen können.

[gutdrauf9]

erklärt sich der 10%ige Kursrückgangmit folgender Meldung ?


Novavax Announces Proposed Public Offering of Common Stock


Nachrichtenquelle: GlobeNewswire 24.03.2015, 21:09

GAITHERSBURG, Md., March 24, 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 it intends to offer to sell, subject to market and other conditions, $175 million of its common stock in an underwritten public offering. As part of this offering Novavax intends to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of its common stock.

J.P. Morgan and Citigroup are acting as joint book-running managers of the offering.

All shares being offered are to be sold by Novavax with the net proceeds from the offering to be used for the advancement of Novavax' lead vaccine candidates, including the preparation and potential initiation of Phase 3 clinical trials of its elderly RSV and maternal RSV programs, as well as its other clinical and preclinical research programs and general corporate purposes, including working capital, product development, manufacturing and process development expenditures and capital expenditures, as well as acquisitions and other strategic purposes.
......

[DasTier666]

2015 bleibt spannend, auch wenn vieles noch in Phase 1 oder 2 steckt. Bleibt halt nur zu hoffen, daß das Cash-Polster nicht zu schnell schmilzt.

...

2015 Anticipated Events:

Announce top-line data from the Phase 1 clinical trial our EBOV GP Vaccine in mid-2015;

Announce top-line data from the Phase 2 clinical trial of our Seasonal Influenza VLP in the second quarter of 2015;

Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine in healthy women in their third trimester of pregnancy in the third quarter of 2015;

Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine in elderly adults in the third quarter of 2015; and

Announce top-line data from the Phase 1 clinical trial of our RSV F Vaccine in healthy pediatrics in late 2015 or in the first half of 2016.

http://globenewswire.com/news-release/2015/02/26/710483/1012…

[DasTier666]

J.P. Morgan Reiterates Upbeat View Of Novavax Following 4Q Results
February 27, 2015

In a research report issued today, J.P. Morgan analyst Cory Kasimov reiterated an Overweight rating on Novavax, Inc. (NASDAQ:NVAX) with a $10 price target, following the company’s second-quarter financial results and update on its pipeline. The company ended the quarter with $168 million in cash and no debt. Given this cash position and with BARDA funding NVAX’s influenza programs, the company has sufficient cash to fund programs into 2016, according to the analyst. ...

http://www.smarteranalyst.com/2015/02/27/j-p-morgan-reiterat…