Dynavax Technologies Corp. ($DVAX) Stock | Company Announces Positive Top Line Results for Phase 3 HEPLISAV-B Study


Dynavax Technologies Corporation (NASDAQ: DVAX)



Dynavax Technologies Corporation (DVAX), a clinical stage biopharmaceutical company yesterday announced positive top line results for their Phase 3 HEPLISAV-B study. HEPLISAV-B is the company’s hepatitis B vaccine. The study compared HEPLISAV-B versus  the currently marketed vaccine Engerix-B. The study showed that both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization of prior trials, and HEPLISAV-B showed statistically significant higher rate of seroprotection compared to Engerix-B in diabetic participants and in all participants.  


Dynavax Technologies Corporation CEO’s Comments

“We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized,” said Eddie Gray, Chief Executive Officer. Market Wired


Chief Medical Officer Comments :

“These topline results are consistent with our expectations. With regard to the principal safety focus, Adverse Events of Special Interest, the results reflect a distribution consistent with randomization. To see such statistically significant differences in immunogenicity so consistently and across all groups and patient subsets, confirms the potential of HEPLISAV-B for people in need of protection,” said Robert Janssen, Chief Medical Officer.  Market Wired


DVAX Technical Analysis


DVAX gapped up in price yesterday to $26.11, up from the prior day’s close of $21.18, which is a 23% increase on favorable news. Taking a look at the daily chart, we can see the last time DVAX traded above this price level was on December 24th when it traded at $27.16. Taking a closer look at the daily chart we can see that DVAX stock has been very choppy recently. Dating back to September 24th DVAX has been in a trading range in between $21 and $28. As of early afternoon trading on Thursday we can see that DVAX has covered all of that range in half a day of trading as highs were $28.14. It will be interesting to see if it can close above the $28 price level and use it as a support level moving forward. DVAX has a float of 33.83 million shares and is trading 12.5 times the normal daily trading volume. For trading purpose, I would be looking for the second break of $28 to go long. My stop loss would be $27.85, fearing anything below that and $28 might be a significant resistance level.


Company Profile

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the United States. It development programs focus on the areas of vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. The company’s product pipeline includes HEPLISAV-B, an investigational adult hepatitis B vaccine, which is in Phase III clinical trials; SD-101, a CpG TLR9 agonist for the treatment of cancer immunotherapy that is in Phase I/II clinical trials; AZD1419, a drug candidate for the treatment of asthma, which has completed Phase I trial; DV1179, a TLR7/9 inhibitor that is in Phase I clinical trial for autoimmune or inflammatory conditions; and DV230-Nanoparticle, a second generation adjuvant that is in preclinical studies. It has a research collaboration and license agreement with AstraZeneca AB for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease; 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 based in Berkeley, California.  Yahoo Finance