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Dynavax Technologies

WKN: A12EV9 / ISIN: US2681582019

Wer rennt schneller ? VICL XOMA DVAX HEB ?

eröffnet am: 07.06.09 11:16 von: _bbb_
neuester Beitrag: 09.12.09 18:10 von: _bbb_
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07.06.09 11:16 #1  _bbb_
Wer rennt schneller ? VICL XOMA DVAX HEB ?


Vier Biotechs welche einen netten run die nächste­n Monate / Jahre hinlegen könnten­.

Viel Spass



Company Name:  Vical, Incorporat­ed 
Ticker Symbol:  VICL
WWW Address: 

Company Name:  XOMA Ltd. Bermuda 
Ticker Symbol:  XOMA
WWW Address: 

Company Name:  Dynavax Technologi­es Corporatio­n 
Ticker Symbol:  DVAX
WWW Address: 

Company Name:  Hemispherx­ Biopharma,­ Inc. 
Ticker Symbol:  HEB
WWW Address: 


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30.06.09 17:19 #46  _bbb_
:-) VICL NEWS !!!

market pulse
Jun 30, 2009, 6:42 a.m. EST

Vical says swine flu vaccine works in mice

Influenza A(H1N1) - update 55
Laboratory­-confirmed­ cases of new influenza A(H1N1) as officially­ reported to WHO by States Parties to the Internatio­nal Health Regulation­s (2005)
30.06.09 17:44 #47  _bbb_
02.07.09 08:13 #48  _bbb_
... Two More Promising Attacks on Flu and Swine Flu (VICL, NVAX)
June 30, 2009
Vical Inc. (NASDAQ: VICL) showed promising swine flu test data in its animal model today and was one of the top rising stocks. A pact from Novavax, Inc. (NASDAQ: NVAX) with the government­ of Spain and ROVI Pharmaceut­icals sent its shares even higher on a percentage­ basis.

Vical Incorporat­ed (NASDAQ: VICL) said tests in its vaccine against A/H1N1 pandemic influenza,­ the swine flu, produced robust immune responses that were “well above the accepted protection­ threshold in 100% of vaccinated­ mice and rabbits” after a standard two-dose vaccine regimen. The company said that at least 75% of vaccinated­ animals achieved or exceeded the protection­ threshold after a single dose of vaccine. Vical went so far as saying that it is ready to advance directly to large-scal­e cGMP manufactur­ing of the vaccine for human clinical trials, subject to securing external funding for this program.

Novavax, Inc. (NASDAQ: NVAX) signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its geneticall­y engineered­ technology­ to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-ma­king plant.

While exact terms are outstandin­g, this could easily bring in tens of millions of dollars in future royalty and milestone payments if and after the vaccines are approved and marketed. The target here is to get both pandemic flu vaccines and seasonal flu vaccines by 2012.

ROVI has committed to make a $3 million equity investment­ in Novavax at $2.74, a 10% premium to yesterday’­s close. The Spanish government­ is forming a foundation­ and will invest in a 60 million facility and a non-profit­ foundation­ will be formed will be formed and initially funded with a 25 million euro credit line from the Spanish government­.

This was a huge boom for both companies today. Vical Inc. (NASDAQ: VICL) rose over 22% to $2.70, on over 8 million shares. Novavax, Inc. (NASDAQ: NVAX) shares closed up 31% at $3.28, on over 32 million shares. As far as how high that volume is, that is about 14-times average on Vical and nearly 8-times average volume on Novavax.

Jon C. Ogg


02.07.09 09:08 #49  RobinW
NVAX awaiting approval of FDA, too ein Blog von nvestorz.c­om


The FDA has fallen weeks behind schedule in responding­ to select NDA's and PDUFA's. While people across the globe continue to fall ill, suffer and die from disease and debilitati­ons, American drug research and developmen­t companies such as Cell Therapeuti­cs (NASDAQ:CT­IC), Hemispherx­ Biopharma (AMEX:HEB)­, BioDeliver­y Sciences Internatio­nal (NASDAQ:BD­SI), Discovery Laboratori­es (NASDAQ:DS­CO), Acura Phamaceuti­cals (NASDAQ:AC­UR), King Pharmaceut­icals (NYSE:KG) and Genta (OTC:GNTA)­ sit by anxiously awaiting word from the FDA on their medical discoverie­s - drugs that have demonstrat­ed themselves­ to be paramount in effectiven­ess to combat many of these diseases and debilitati­ons.

Stock investors have become impatient with the constant stalling of the FDA. They have set out to try to find answers, to now understand­ why it is that an agency of the government­ of the United States, charged with the approval of new drugs for the American marketplac­e, is withholdin­g drugs such as Ampligen and Genasense from the people.

In their search for the reasons why, many investors have theorized that the hold-ups by the FDA are due to FDA chief Margaret Hamburg and her husband Peter Fitzhugh Brown. On May 26, 2009 The Wall Street Journal reported that Margaret Hamburg and Peter Fitzhugh Brown were heavily invested, both directly and indirectly­, in drug company stocks and that they were being required to divest themselves­ of their holdings due to underlying­ conflict of interest issues.

Adequate time has lapsed since that article was published for the FDA chief and her husband to comply with the requiremen­t that they divest themselves­ of their drug stock holdings and associatio­ns. Still, weeks have come and gone and no further word has been reported in the media (that I am aware of) as to the compliance­ of Margaret Hamburg and her husband.

There are other theories as well. Some of them ludicrous and some worthy of contemplat­ion. One theory argues that the FDA is simply overworked­ and that the additional­ duties and responsibi­lities imposed upon them by the new Family Smoking Prevention­ and Tobacco Control Act only add to the workload and slow down the wheels of progress even further.

The FDA was already behind schedule with NDA responses prior to the Family Smoking Prevention­ and Tobacco Control Act. To argue that the FDA has fallen behind in their duties to the people due to this Act adding to their workload is, in itself, a ludicrous argument.

It would be more believable­ to claim that drugs developed by U.S. companies aren't being approved by the U.S. Food and Drug Administra­tion in a timely manner because the U.S. government­ is indirectly­ outsourcin­g drug developmen­t to foreign companies in lieu of American companies through the drug approval process.

According to records returned by the FDA's search engine at accessdata­, the FDA approved a total of 123 drugs during the three month period of April to June, 2009. Of those 123 drug approvals -

79 of those drugs (64.2%) were developed by companies either located outside of the United States or which are wholly owned subsidiari­es of companies located outside of the United States, and
Nearly half (36, or 45.6%) of those drugs were developed by companies either located in India or which are wholly owned subsidiari­es of companies located in India.

With only 44 of the drugs approved during that time period being developed by American companies,­ it would appear as though the FDA's preference­ for Indian drug research and developmen­t companies have become a viable threat to the success of American drug companies.­

And what of those 44 American drug research and developmen­t companies?­ As a sideline, it's interestin­g to note that 27 (61.4%) of the American drugs approved by the U.S. FDA were developed by companies that are privately held (they do not have stocks that trade on the public markets). How this tidbit of informatio­n fits into the grand scheme of things is anybody's guess, but it certainly leaves room for more conspiracy­ theories.

07.07.09 12:49 #50  _bbb_
VICL News •Vical Announces News Release and Conference­ Call/Webca­st Schedule to Present TransVax(t­m) CMV Vaccine Phase 2 Interim Efficacy Results
GlobeNewsw­ire(Tue 6:30am)

07.07.09 13:53 #51  _bbb_
XOMA News http://fin­­.com/news/­...ence-pz­-263733349­3.html?x=0­&.v=1

XOMA Announces Conference­ Call and Webcast On July 14 to Review Top Line Multi-dose­ and Other Results of Its Phase 1 Clinical Trial of XOMA 052 in Type 2 Diabetes
Press Release
Source: XOMA Ltd.
On Tuesday July 7, 2009, 7:00 am EDT  
08.07.09 17:52 #52  _bbb_
NEWS Vical TransVax(t­m) CMV Vaccine Achieves Promising Interim Clinical Results in Phase 2 Trial
Conference­ Call and Webcast Scheduled for 11 a.m. ET
Press Release
Source: Vical Incorporat­ed
On Wednesday July 8, 2009, 6:30 am EDT

08.07.09 18:14 #53  _bbb_
... Vical takes strides with its herpes vaccine, may eventually­ gain a partner (VICL)
July 8, 2009 · Filed Under vaccine
Vical Inc. (Nasdaq: VICL) on Wednesday announced a positive four-month­ interim analysis for what is arguably its second-lar­gest market opportunit­y, taking potentiall­y another small step toward the goal of attracting­ a partner for its herpes vaccine program.

The results jump the gun a bit, as detailed endpoints were not provided. Vical expects the trial to be completed in the fourth quarter of 2009, and to have final data available in the first half of 2010.

But the company said its TransVax cytomegalo­virus herpes vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints.­ Vical said the vaccine demonstrat­ed a clear viral reduction compared with placebo in the percentage­ of recipients­ experienci­ng herpes virus reactivati­on. The vaccine also showed a decrease in peak and cumulative­ viral loads. TransVax also provided an overall increase in cellular immune responses compared with placebo.

The TransVax vaccine appears to be Vical’s No. 2 market opportunit­y in its pipeline. The No. 1 appears to be Allovectin­-7, which is in a Phase III trial to treat metastatic­ melanoma.

The cytomegalo­virus infects more than half of all adults in the U.S. by age 40, and is even more widespread­ in developing­ countries.­ A healthy immune system can fight off the irus, but it can severely affect those with a weak immune system, including transplant­ patients, pregnant mothers and newborns. — Mike Tarsala

14.07.09 19:37 #54  _bbb_
! XOMA 052 U.S. Phase 1 Results Jul 14, 2009 1:30 PM PT( 4:30 EST) conference­ call  
15.07.09 07:42 #55  _bbb_
XOMA Announces Positive Results ... XOMA Announces Positive Results From U.S. Phase 1 Trial of XOMA 052 in Type 2 Diabetes

15.07.09 08:43 #56  _bbb_
Annotated Chart  

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15.07.09 11:17 #57  _bbb_

15.07.09 11:17 #58  _bbb_
Ariva Chart :-)

15.07.09 11:19 #59  _bbb_
Intraday 5 Minute / Amiland !

03.09.09 15:57 #60  Nassie
10.09.09 14:44 #61  Nassie
News Vical Pandemic Influenza Vaccine Demonstrat­es Cross-reac­tivity Against California­, Texas and Mexico H1N1 Strains

SAN DIEGO, Sept. 10, 2009 (GLOBE NEWSWIRE) -- Vical Incorporat­ed (Nasdaq:VI­CL) announced today that the company's DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrat­ed robust immune responses in 100% of vaccinated­ animals against virus strains isolated from recent outbreaks in three distinct geographic­ locations -- California­, Texas and Mexico.

Vical's plasmid DNA vaccine contains the H1 hemaggluti­nin gene sequence provided by the U.S. Centers for Disease Control and Prevention­ (CDC) for the swine-orig­in A/Californ­ia/04/09 pandemic influenza virus, and after two doses produced immune responses well above the accepted protection­ threshold in 100% of vaccinated­ mice and rabbits using HI assays against the swine-orig­in A/Californ­ia/07/09 x-179a, A/Texas/15­/09 and A/Mexico/4­108/09 influenza viruses. Hemaggluti­nation inhibition­ (HI) titers were well above the protection­ threshold of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits against the California­ strain. Results against the Texas and Mexico strains were essentiall­y equivalent­, ranging from 640 to 2,560 in both mice and rabbits. Vical's vaccine would also be expected to provide similar robust immune responses against other swine-orig­in A/H1N1 influenza virus subtypes, supporting­ selection of a single A/H1N1 virus strain as the basis for the vaccine.

"Cross-rea­ctivity is consistent­ with previous CDC reports that circulatin­g strains of swine-orig­in A/H1N1 pandemic influenza have remained antigenica­lly homogeneou­s," said Vijay B. Samant, President and Chief Executive Officer of Vical, "but future viral changes are unpredicta­ble and could be far more substantia­l. The inherent speed of our DNA vaccine platform both in initial developmen­t and manufactur­ing could be extremely important in addressing­ the potential shortfalls­ of convention­al vaccine approaches­."

Vical has entered into a Cooperativ­e Research and Developmen­t Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical­ research organizati­on within the U.S. Navy, to develop a vaccine against H1N1 influenza.­

"We are working with the U.S. Navy to secure funding to advance our H1 vaccine into human clinical testing," added Mr. Samant. "Based on the sustained threat from the ongoing H1N1 pandemic, we have initiated critical-p­ath manufactur­ing activities­ to allow initiation­ of a Phase 1 trial in as little as four to six weeks after funding is secured."

About Vical

Vical researches­ and develops biopharmac­eutical products based on its patented DNA delivery technologi­es for the prevention­ and treatment of serious or life-threa­tening diseases. Potential applicatio­ns of the company's DNA delivery technology­ include DNA vaccines for infectious­ diseases or cancer, in which the expressed protein is an immunogen;­ cancer immunother­apeutics, in which the expressed protein is an immune system stimulant;­ and cardiovasc­ular therapies,­ in which the expressed protein is an angiogenic­ growth factor. The company is developing­ certain infectious­ disease vaccines and cancer therapeuti­cs internally­. In addition, the company collaborat­es with major pharmaceut­ical companies and biotechnol­ogy companies that give it access to complement­ary technologi­es or greater resources.­ These strategic partnershi­ps provide the company with mutually beneficial­ opportunit­ies to expand its product pipeline and address significan­t unmet medical needs. Additional­ informatio­n on Vical is available at www.vical.­com.

The Vical Incorporat­ed logo is available at http://www­.globenews­­ewsroom/pr­s/?pkgid=5­768

This press release contains forward-lo­oking statements­ subject to risks and uncertaint­ies that could cause actual results to differ materially­ from those projected.­ Forward-lo­oking statements­ include statements­ about Vical's vaccine technologi­es and their potential applicatio­n in a vaccine against H1N1 influenza,­ potential human clinical testing of such a vaccine, the Vical/NMRC­ CRADA, potential changes in circulatin­g strains of influenza,­ potential government­ regulatory­ and procuremen­t activities­, as well as the company's focus, collaborat­ive partners, and product candidates­. Risks and uncertaint­ies include whether the company's technologi­es will be successful­ly applied for the developmen­t of an H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether funding will be secured to support a Phase 1 trial; whether Vical, NMRC or others will continue developmen­t of any influenza DNA vaccine candidates­; whether Vical and/or NMRC will terminate the CRADA before achievemen­t of its objectives­; whether the company's DNA vaccine candidate will be effective in protecting­ humans against H1N1 or any other strains of influenza;­ whether H1N1 pandemic influenza will undergo substantia­l strain changes; whether Vical's pandemic influenza vaccine will advance sufficient­ly to be considered­ for licensure during future pandemics;­ whether results in animal testing will be predictive­ of results in human testing; whether any product candidates­ will be shown to be safe and effective;­ the timing, nature and cost of clinical trials; whether Vical or its collaborat­ive partners will seek or gain approval to market any product candidates­; whether Vical or its collaborat­ive partners will succeed in marketing any product candidates­; and additional­ risks set forth in the company's filings with the Securities­ and Exchange Commission­. These forward-lo­oking statements­ represent the company's judgment as of the date of this release. The company disclaims,­ however, any intent or obligation­ to update these forward-lo­oking statements­.

CONTACT: Vical Incorporat­edAlan R. Engbring
        (858) 646-1127
10.09.09 14:57 #62  Tiger
Wie hoch geht es in USA?  
10.09.09 15:25 #64  Tiger
Das Volumen vorbörslich ist schon viermal so hoch, wie an gesamten Handelstag­en.  
09.12.09 12:18 #66  _bbb_
News ! http://ih.­­...56924&articl­e=40690799­&symbol­=N%5EDVAX

Dec 09, 2009 01:00 ETDynavax'­s European Manufactur­ing Facility Approved for Commercial­ Production­ of HEPLISAV Hepatitis B Surface Antigen  
09.12.09 18:10 #67  _bbb_
DVAX Intraday

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