Dynavax Technologies Corp (NASDAQ:DVAX)

CAPS Rating: 3 out of 5

A biopharmaceutical company that discovers and develops Toll-like Receptor 9 and agonist-based products to treat and prevent infectious diseases, allergies, cancer and chronic inflammatory.

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Member Avatar SqwiiTrader (< 20) Submitted: 2/21/2014 4:40:48 AM : Outperform Start Price: $1.92 DVAX Score: -26.81

insider heavy buy finviz

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Member Avatar Aaryan (36.55) Submitted: 2/11/2014 10:16:22 AM : Outperform Start Price: $1.92 DVAX Score: -29.95

Hidden Gem!!!

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Member Avatar SyDVooh (< 20) Submitted: 2/6/2014 11:40:19 AM : Outperform Start Price: $1.69 DVAX Score: -21.46

DVAX has a hepatitis B vaccine that works. It will probably be approved in Europe later this year. That will raise the stock price and make DVAX a takeover target. They are also working on other drugs with GlaxoSmith Kline and Astrazeneca, two solid companies, so it is not a one trick pony as a lot of small cap pharm stocks are. Plus there has been considerable institutional buying lately.

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Member Avatar TerryHoodSr (45.95) Submitted: 12/30/2013 8:11:53 AM : Outperform Start Price: $1.97 DVAX Score: -29.87

spec TP $5

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Member Avatar farfetched1 (< 20) Submitted: 11/27/2013 11:08:41 AM : Outperform Start Price: $1.68 DVAX Score: -18.37

With an Initiate out of MFI Capital with BUY $5 dollar price target, I see the price target 12 month of $7-$8 range.

Dynavax has pioneered a new approach in their quest for therapies dealing with multiple autoimmune and inflammatory diseases including lupus, psoriasis, and rheumatoid arthritis.

Dynavax technology consists of oligonucleotide-based immunoregulatory sequences (IRSs) that inhibit Toll-like Receptors (TLRs) 7, 8, and/or 9. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.

Their TLR inhibitors have demonstrated a highly targeted effect on key immune cells and pathways that play a role in multiple autoimmune and inflammatory diseases. In contrast, most currently marketed and in their pipeline products are broadly immunosuppressive with variable efficacy and substantial toxicity.

Under their worldwide strategic alliance with GlaxoSmithKline (GSK), established in 2008, they are developing DV1179, a bi-functional inhibitor of TLR7 and TLR9. In a 2010 article published in NATURE, Dynavax scientists showed that activation of the innate immune system by TLR7 and TLR9 can cause glucocorticoid resistance in lupus patients. This resistance was reversed by Dynavax's novel TLR7/TLR9 inhibitors in both human blood cells and in vivo animal models of lupus.

In October 2011, based on novel preclinical data, Dynavax announced the expansion of their alliance with GSK to include TLR8 as a new target. The activation of TLR8 in myeloid cells yields the production of multiple pro-inflammatory cytokines, including tumor necrosis factors (TNFs), IL-1, IL-6 and IL-12. They will further evaluate the hypothesis that inhibition of TLR8 could prevent the inflammatory cascade initiated by these cytokines in many autoimmune conditions.

Under the terms of Dynavax alliance, GSK can exercise its exclusive option to license each program upon achievement of certain events, and they are eligible to receive option exercise payments. Dynavax are also eligible to receive tiered, up to double-digit royalties on sales and have retained an option to co-develop and co-promote one product.

IN SUMMARY

Recent Phase 1 and 2 are showing extremely promising war chest with their partnerships with

The Th1 Response

The Th1 response involves the production of the body’s most potent anti-infective weapons – specific cytokines, including interferon-alpha, interferon-gamma and interleukin 12 (IL-12), as well as killer T cells, a specialized immune cell. In addition, the Th1 response generates IgG antibodies to help rid the body of foreign antigens and allergens. Once a population of Th1 cells specific to a particular antigen or allergen is produced, it persists for a long time in the form of memory Th1 cells, enabling a more rapid and powerful immune response the next time exposure to that particular antigen or allergen occurs. An insufficient Th1 response to an infection can result in chronic disease, whereas an inappropriate Th1 response can cause diseases such as rheumatoid arthritis.
The Th2 Response

Activation of the Th2 response involves the production of other cytokines, IL-4, IL-5 and IL-13, which attract inflammatory cells, such as eosinophils, basophils and mast cells, to destroy the invading organism. The Th2 response also leads to the generation of IgE, a specialized antibody that can recognize antigens and allergens and further enhance the protective response. An inappropriate Th2 immune response to allergens, such as plant pollens, can lead to chronic inflammation resulting in allergic rhinitis, asthma and other allergic diseases. Subsequent exposures to the same allergens can reactivate memory Th2 cells, sustaining inflammation and leading to chronic disease.

Keep this one on your rare finds ready to take off on a early entry of currently $1.55 - $1.75 range.

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Member Avatar rknapton (< 20) Submitted: 8/6/2013 7:30:28 PM : Underperform Start Price: $1.35 DVAX Score: +4.29

Short. Biopharma. Revs down. Selling more and more stock.

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Member Avatar whoodatstockhot (88.70) Submitted: 7/9/2013 11:31:37 AM : Outperform Start Price: $1.16 DVAX Score: +10.83

Big upside here, solid management team, nice catalysts, and dirt cheap.

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Member Avatar getrichdietrying (82.25) Submitted: 6/12/2013 9:34:46 PM : Underperform Start Price: $1.38 DVAX Score: +12.03

A biopharmaceutical company that discovers and develops Toll-like Receptor 9 and agonist-based products to treat and prevent infectious diseases, allergies, cancer and chronic inflammatory.

sure

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Member Avatar swa5469 (< 20) Submitted: 5/16/2013 12:15:06 PM : Outperform Start Price: $2.49 DVAX Score: -57.07

Good drugs in the pipe-line. Once management stabilizies and Europe comes on board, we should see some nice positive movement upwards.

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Member Avatar adfishow (24.16) Submitted: 3/16/2013 10:10:45 PM : Outperform Start Price: $2.13 DVAX Score: -55.74

It's a speculation but I believe teh drug wil be approve and a big money maker

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Member Avatar genedom (97.41) Submitted: 2/20/2013 2:53:41 AM : Outperform Start Price: $2.99 DVAX Score: -76.85

FDA will approve the better HBV vaccine this time, even with a post trial.

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Member Avatar warrenicahn (64.26) Submitted: 1/2/2013 10:10:53 AM : Outperform Start Price: $2.92 DVAX Score: -82.61

New drug will receive approval in February, and two other new drugs in phase 1 will make this a valuable company.

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Member Avatar zzlangerhans (99.76) Submitted: 11/21/2012 2:00:49 AM : Outperform Start Price: $2.36 DVAX Score: -80.24

In July 2011 Dynavax reported topline results from the HBV-16 phase III trial of their Hepatitis B vaccine Heplisav in adults aged 40-70. They found that two doses of Heplisav administered one month apart conferred 90% seroprotection 8 weeks after the last dose and 92% seroprotection 52 weeks after the first dose, while standard of care vaccine Engerix-B conferred 70% seroprotection 8 weeks after the last dose and 59% seroprotection 52 weeks after the first dose.

Despite this seemingly indisputable efficacy benefit for Heplisav, the share price actually dropped significantly after the results were released for three reasons:

1. The company reported that the Heplisav group did not meet pre-specified consistency criteria for antibody production after 8 weeks, thereby technically failing the primary endpoint.
2. Three new onset autoimmune events occurred in the Heplisav group and none occurred in the Engerix group. The company claimed this could be attributed to chance given the 4:1 randomization of patients to Heplisav vs Engerix.
3. Many traders sold on the news as Dynavax stock had risen dramatically from 2008 lows and the commercial prospects for Heplisav seemed questionable at that time.

The share price did rebound after the company reassured investors that according to FDA standards, consistency criteria were met. However, ongoing nervousness about Heplisav's revenue potential resulted in a severe downturn during the broad market instability of late 2011 and a low of 1.82. This, as it turns out, was a very good time to buy and I came close to capturing the low with a green thumb here http://caps.fool.com/Pitch/DVAX/5983252/dynavax-rose-as-high-as-316-in.aspx , but I felt the stock was too risky for real money. From October 2011 to May 2012 the share price nearly tripled to a high of 5.26. Only another monster dilutive financing of 70M was able to dampen the upward momentum.

I have to admit I'm still very confused about what happened to Heplisav in late 2011 and early 2012, and went deep into negative points territory with my red thumb http://caps.fool.com/Pitch/DVAX/6118083/i-recently-did-well-on-a-green.aspx

I based my long-term pessimistic view of Dynavax on the results of the PHAST phase III trial of Heplisav in 2008. After the FDA severely restricted the potential population for Heplisav in 2008 due to a single case of Wegener's granulomatosis in a test subject, the share price dropped as low as 0.16 and Merck terminated the partnership on Heplisav. It is possible that the only thing that saved Dynavax from the 2008 lows was the announcement of an unrelated partnership with GSK to develop inhibitors of Toll-like receptors for inflammatory diseases. This announcement resulted in a six-fold increase in share price and gave the company enough strength to restore their cash runway through dilution. Dynavax has subsequently gone on to take liberal advantage of the capital markets through private placements and ATM's, such that their common share count has ballooned from 55M in May 2010 to 179M as of the last quarterly statement. Dynavax's appreciation in share price was dwarfed by their appreciation in market cap.

In September 2009 the FDA lifted the clinical hold on Heplisav and Dynavax initiated a new phase III trial of Heplisav in patients with chronic kidney disease, as the FDA had indicated that Heplisav might have an acceptable risk/benefit profile in this subpopulation. The company initiated the HBV-16 trial in early 2010 as a "lot-to-lot consistency trial" which was also intended to expand the safety database. While this was not initially portrayed as a registrational efficacy trial, it appears that Dynavax used it as a Trojan Horse to sneak another phase III efficacy trial for general population past the FDA despite the previous clinical hold.

Subsequent to the latest phase III trial results, Dynavax announced their intention to submit an initial BLA for the general population of adults over 40, followed by a supplemental BLA for chronic kidney disease patients after the initial BLA was approved. This plan came despite what appeared to be a drastic and uncompromising view by the FDA in 2008 that Heplisav had an unacceptable risk/benefit profile except for specific hyporesponding subsets. Then in February 2012 Dynavax announced after a pre-BLA meeting with the FDA that the Heplisav submission would be expanded to adults aged 18-70. It now appeared that the FDA had completely retraced their position on Heplisav safety, abandoning all prior restrictions to Heplisav usage.

Fast forward to November 2012 and the FDA Advisory Committee meeting on Heplisav. Based on the buzz from the street, it seemed that any prior FDA concerns about autoimmune adverse events were forgotten and a strongly positive vote was practically a foregone conclusion. Never mind the 2008 clinical hold, never mind the prior drastic restriction on Heplisav usage handed down by the FDA, never mind the dramatic dilution Dynavax utilized to build a huge 160M war chest ahead of the meeting. Of course, it turned out that these were all warnings to dump the position ahead of an eventual 8-5 committee vote that Dynavax had not convincingly demonstrated Heplisav's safety.

The vote decimated the share price and was a great pick in after hours with a low around 1.7. The degree of the drop was excessive considering that a lot of large funds and institutions are now deeply underwater on the trade and will be working overtime to push the share price back up prior to the PDUFA on 2/24/13. We'll be hearing a lot between now and the PDUFA about how the FDA briefing documents didn't raise concerns about adverse autoimmune events, and how the Ad Comm chairman was conflicted by ties to GSK (maker of Engerix), and various other reasons why Heplisav will get first pass FDA approval.

Personally, I wouldn't bet on it. Heplisav represents a nice upgrade to the current array of hep B vaccines but it's far from indispensable. Historic measurements of seroprotection by Engerix B and Recombivax-HB are substantially better than the findings in Dynavax's trials.

http://adisonline.com/drugs/Abstract/2003/63100/Recombinant_Hepatitis_B_Vaccine__Engerix_B_R____A.6.aspx

I think it's very unlikely that the FDA will go against a safety recommendation from their own Advisory Committee for a solution to a problem (hep B vaccine efficacy) that may not even exist. Dynavax has already enjoyed a substantial rebound from the lows after the Ad Comm vote and is likely to move even higher before the PDUFA. But if you're underwater on this stub I wouldn't cross my fingers and hold through the PDUFA. This time, head for the lifeboat.

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Member Avatar SamsaricSufferer (< 20) Submitted: 11/17/2012 12:08:52 PM : Outperform Start Price: $2.50 DVAX Score: -81.08

Bounce play on a fundamentally sound company.

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Member Avatar Beststocks99 (41.06) Submitted: 3/8/2012 11:58:06 AM : Outperform Start Price: $4.17 DVAX Score: -106.09

Things are working with the FDA

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Member Avatar helpmesav (< 20) Submitted: 12/31/2011 12:32:50 PM : Outperform Start Price: $3.37 DVAX Score: -107.63

Heplisav will be approved last quarter 2012 and their pipleine is strong

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Member Avatar Bumkinpops (< 20) Submitted: 9/21/2011 7:30:43 PM : Outperform Start Price: $1.96 DVAX Score: -94.71

Lead product Heplisav should be approved as efficacy, safety and manufacturing consistency all appear to have been achieved. FDA submition within 3 months and significant advantages over current market leader engerixB. This product alone justifies three times the current market cap. Add to that the pipeline, most significanlty the Universal flu vaccine, based on the same technology that created Heplisav.

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Member Avatar KimLanners (< 20) Submitted: 7/20/2011 12:04:39 PM : Outperform Start Price: $2.52 DVAX Score: -87.16

biot

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Member Avatar bruceedge (< 20) Submitted: 6/19/2011 2:15:36 PM : Outperform Start Price: $2.57 DVAX Score: -95.24

good pipeline in the works and a good technical chart cupping around it's 200 day M.A.

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Member Avatar Fuzzy114 (< 20) Submitted: 4/6/2011 4:33:58 PM : Outperform Start Price: $2.78 DVAX Score: -91.81

Very good sponsorship by institutional funds. Employees enjoy partnership in ownership. They are burning rubber.
Would not like to be short Dvax.
Fuzzy114

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