Dynavax DVAX Gets FDA Heplisav Hold Lifted

September 10, 2009 - After an 18 month hold for safety concerns, Dynavax Technologies Corporation (DVAX) told investors this morning that the FDA has lifted the Hold on Heplisav. Shares of DVAX are set to open at $2.50 Up 43%. What is Heplisav? Heplisav is a vaccine aimed at treating Hepititis B.

Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine


Dynavax Technologies Corporation (Nasdaq:DVAX) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

As a result of the FDA's decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.

"The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "After achieving strong efficacy data in our prior Phase 3 pivotal trial, we are fully prepared to initiate the final registration trials for HEPLISAV."

Dynavax's global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others. Full Article

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Swine Flu Stocks April 27, 2009 4/27/09

The following is a list of swine flu stocks that in some way have potential vaccines or drugs that could potentially help to solve this problem. Nonetheless, these stocks have and will be one fire as long as the swine flu is out there.

Swine Flu Stock List: - Discuss the Swine Flu Stocks at http://stockstobuy.org

Roche Holding Ltd. (ADR) ( RHHBY )
Gilead Sciences, Inc. ( GILD )
GlaxoSmithKline plc (ADR) ( GSK )
Crucell N.V. (ADR) ( CRXL )

Novavax, Inc. ( NVAX )

PURE Bioscience ( PURE )
GenVec Inc. (GNVC)
Generex Biotechnology Corporation ( GNBT )
BioCryst Pharmaceuticals, Inc. ( BCRX )
Hemispherx BioPharma, Inc ( HEB )
AVI BioPharma, Inc ( AVII )
Dynavax Technologies Corporation ( DVAX )

Alpha Pro Tech Ltd. (APT) - they make health protection gear
Sinovac Biotech Ltd. (SVA) - flu vaccine - china
CEL-SCI Corp. (CVM)
Inhibitex Inc. (INHX)

Today's Biggest Stock Market Gainers - Top 2009 Stock Gainers - Top 2009 Penny Stocks - Stock Message Board

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Hot Penny Stocks 2/9/09 February 9, 2009 DVAX

Today, 2/9/09, there are a few penny stock gainers breaking out to the upside. Be sure to check out the Top 2009 Penny Stock Gainers on the NYSE, Nasdaq, and AMEX.

Penny Stock Gainers - February 9, 2009

Dynavax ( DVAX ) - $0.82 Up 32.24% - DVAX stock is surging because the FDA asks for more data on Dynavax's hepatitis vaccine.

Axcelis Technologies ( ACLS ) - $0.33 Up 13.50% - ACLS spiking higher today, can't find any news.

Novadel Pharmaceuticals ( NVD ) - $0.38 Up 15.88% - NVD stock spiking higher on no news.

Apollo Gold ( AGT ) - $0.37 Up 15% - AGT is going up on no news that I can find. Gold stocks have been flying lately so Gold Penny Stocks will follow.

Check out the biggest stock gainers today.

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Today's Biggest Gainers 12/18/08 DVAX STEM

This morning, 12/18/08, we have several hot stocks breaking out to the upside. It seems as though all the penny stocks are the biggest gainers this week. I haven't seen so many penny stocks on the top gainers list in awhile.

Hot Stocks to Watch - December 18, 2008

Dynavax ( DVAX ) - DVAX is at it again, after soaring yesterday, this stock is over $2 in pre market trading on partnership news with GSX.

Stem Cells ( STEM ) - STEM received FDA Approval to start a clinical trial.

Avigen ( AVGN ) - Selling rights of a research program to Baxter for $7 million.

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Today's Biggest Gainers - SAY DVAX 12/17/08

This morning 12/17/08, there are several hot stocks that are breaking out in pre market trading.

Today's Biggest Gainers December 17, 2008

Satyam Computer ( SAY ) - up 42% to $8.10 - This Indian company cancelled their plans to buy a few firms. Satyam, India's No. 4 software services exporter, bowed to investor outrage and cancelled the plans to buy two builders just 12 hours after the deals were announced.

Dynavax ( DVAX ) - Up 200% to .79% - GlaxoSmithKline (GSK) signed a partnership to develop treatments for immuno-inflammatory diseases with Dynavax Technologies Corp. (DVAX), which could eventually reap worth more than $800 million including all options.
Dynavax, a Berkeley, Calif., biopharmaceutical company, will get an initial payment of $10 million from the British drug maker. Dynavax will conduct research and early clinical development in up to four programs and could get total milestone payments of about $200 million per program.

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