Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the United States. Its development programs focuses on vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. The company's lead products include HEPLISAV-B, an investigational adult hepatitis B vaccine, which is in Phase III clinical trials; and SD-101, a C Class CpG TLR9 agonist for the treatment of cancer, which is in Phase I/II multicenter clinical trial. Its product portfolio also comprises AZD1419 for the treatment of asthma, which is in Phase II clinical trial; DV1179, a TLR7/9 inhibitor that is in Phase Ib/IIa for the treatment of autoimmune and inflammatory conditions; and DV281 and CpG-Nanoparticles, which are in preclinical studies for cancer immunotherapy. It has a research collaboration and license agreement with AstraZeneca AB to conduct a Phase IIa safety and efficacy trial of AZD1419 for the treatment of asthma; and strategic alliance with GlaxoSmithKline to discover, develop, and commercialize TLR inhibitors. The company was formerly known as Double Helix Corporation and changed its name to Dynavax Technologies Corporation in September 1996. Dynavax Technologies Corporation was founded in 1996 and is headquartered in Berkeley, California.
BERKELEY, CA--(Marketwired - September 04, 2016) - Dynavax Technologies Corporation (DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
DVAX smacked down to 3.35, -71% Dynavax's stock plunges after disappointing FDA response to Hep-B treatment
http://www.marketwatch.com/story/dy...ng-fda-response-to-hep-b-treatment-2016-11-14 Not a complete rejection, and the company's CEO thinks they can still get approval. And they're looking for a necessary buyout.
$DVAX FDA has committed crime in the name of science to help big pharma, make drug expensive for years!
^^ Will be interesting to see how it all turns out but i sold out on Wed. Dynavax hepatitis B vaccine works; raises safety issues -FDA https://finance.yahoo.com/news/dynavax-hepatitis-b-vaccine-works-133403787.html
DVAX selling is a great chance to buy cheaper! Remember FDA has 6 months after Ad-com decision. I wondered why PDUFA was within 2 weeks
