dvax 2.2 +20% after a meeting with fda heplisav ph3 against hepatitis b will be resumed in september, upon clinical hold removal; excellent earnings in 1st half of 2009, cash of 53 millions

Do these guys have a swine flu? You know of one.
BCRX BioCryst is the only one I know in the very near pipe line, but $10 a share is not my kind of play.

I've been wondering the same thing. Yesterday, the headline of the Seattle Times read, "50% of the US will get Swine Flu during the upcoming flu season."

1.71 +.08

Keep your eye on this one, GL.

up 50% this morning!

Sold all 1k shares for $3.05 from $1.59

On to the next one, wheeee!

I'm liking DVAX here...

in in the 1.70's for a bounce...
coming up on the 1 month time frame (wash rule buy back for those who lost on Sep 9)

g

Lookin good, long 60K shares

Good Luck...

thanks, liking the action on DVAX into the close... could be a nice set up for next week.

(hitting HOD near the end of trading,... actually, HO week and volume increasing into close plus more volume friday than on a typical day last week)
g

Thanks for bringing this to my attention Gambler! Liking the chart setup as well. Played it before and haven't followed since, any FDA news coming up that I should be weary of so I don't get caught up in the wrong end of?

No prob
as far as upcoming events, there aren't any that I know about except maybe the earnings call in november (and I will be long gone by then). This is a 2day-1 week hold for me... this is also a swine flu stock

http://seekingalpha.com/article/1644...e-are-they-now

and since the SF stocks ran up friday there will also be some pin action with dvax, imo.

but of course this is not really a pin action play, it is an oversold play that at this point has more reward than risk, imo.

One other theory I have had about bouncer stocks is that they are more likely to bounce after a month, reason being that the wash sale rule kicks into effect. Now this usually takes effect in stocks that have been crushed, as people can buy them back 1 month later with out wash sale restrictions, but I have also seen it with stocks that gapped up 1 month before. Reason being that if you look at the candlestick for that date (Sep 9, I believe) the stock spent most of the day selling off, and there were a ton of people who bought high near the open and sold at the end of the day for a 20-30% loss... They cannot rebuy the stock until 1 month later or they get wash sale issues... what better time to rebuy now (monday) so they can get back in, outside of the WS timeframe?

g

meh, not liking the action today
sold 62K at about 1.80 average, + 2.7K
g

Feeling good about this for tomorrow.. Any thoughts?

Dynavax Reports Positive Phase 1b Data for SD-101 in Chronic Hepatitis C Infection

Dynavax Reports Positive Phase 1b Data for SD-101 in Chronic Hepatitis C Infection

In vitro Study Shows SD-101 Induces Both IFN-lambda and IFN-alpha

(Marketwire - 01/26/10) - Dynavax Technologies Corporation (NASDAQVAX - News) announced today data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

Data from the Phase 1b study of SD-101 in treatment-na�ve, genotype 1 HCV patients show:

-- A safety and tolerability profile that compares favorably to that of
IFN-alpha, at all four doses tested;
-- A dose-dependent antiviral response, with 100% of patients at the
highest dose experiencing a greater than one (1) log reduction in viral
load; and
-- The potency of SD-101 as confirmed by biomarker analysis in patients.
The biomarker data point to substantial, dose-related increases in the
expression of key antiviral genes (MX-B and ISG-54k) and genes indicating
enhanced immunity (IP-10 and MCP-1).

The Phase 1b study evaluated four dose levels of SD-101 in 34 chronically infected, treatment-na�ve, genotype 1 HCV patients. SD-101 was administered as a monotherapy once weekly, for four weeks, in doses from 0.1 to 5.0 milligrams per week.

The in vitro data from a study of the drug in human blood cells demonstrate that compared to first-generation TLR9 agonists, SD-101 stimulates 20-fold higher levels of both IFN-alpha and IFN-lambda, two classes of IFNs with potent activity against HCV.

According to the Company's Chief Medical Officer, J. Tyler Martin, M.D., "The unique and highly potent pattern of IFN-lambda and IFN-alpha induction by SD-101 represents a novel, differentiated approach for HCV. The safety and antiviral activity demonstrated in this Phase 1b study compares favorably to current treatments, and we believe that further study may support a role for SD-101 as a supplement to current or emerging therapies to treat HCV."

With the completed acquisition of Symphony Dynamo earlier this month, Dynavax has full development and commercialization rights to SD-101. As such, SD-101 has been added to a portfolio of development programs available for partnership from Dynavax.

About HCV

According to the World Health Organization, there are 170 million people worldwide chronically infected with HCV. Over 80% of HCV infections become chronic and can progress over a period of 10 - 40 years. Nearly half of all liver transplants in the U.S. are performed for end-stage hepatitis C. Approved therapies to treat hepatitis C, including pegylated interferon-alpha and ribavirin, represent a market of approximately $3 billion. However, these therapies often cause significant side effects and are effective in treating only about half of all patients infected with HCV.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines.

Lots of after market volume. It ran up but then checked back down. Tomorrow morning could be interesting. Any ideas?

It looks like it wants to breakout:

http://finviz.com/publish/051110/DVAXc1dl1127.png

Large volume spike last Friday. Still has to break $2 range though.

Upcoming Catalyst review

 

http://biotechtrader34.blogspot.com/p/phase-2-phase-3-calendar.html

 

Drug: HEPLISAV™ Hepatitis B vaccine

Target:
Adult hepatitis B vaccine that is designed to provide rapid and superior protection with fewer doses than current licensed vaccines. Our global strategy 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

Catalyst:
The 12-month follow-up of the phase III study evaluating immunogenicity in comparison to Engerix, lot-to-lot consistency and safety was completed in May of this year. The results of this study are expected to be reported next month

Reviews:

Jefferies: Target $4
GekkoWire: GekkoWire analysis

Approximate Timing: July 2011

Dynavax Reports HEPLISAV(TM) BLA Submission

 

BERKELEY, CA--(Marketwire -04/26/12)- Dynavax Technologies Corporation (DVAX - News) today announced that it has submitted a U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said:

This submission is a very important milestone for Dynavax. The final document consists of 305 volumes, and the expansion of the indicated age group following the pre-BLA meeting required complete rewrites of the clinical summaries. The entire HEPLISAV team did outstanding work to complete the revisions and submit the BLA ahead of schedule.

We have requested priority review for HEPLISAV, as we believe it is a significant improvement compared to marketed products. We look forward to working with the FDA on the BLA and to ultimately bringing the benefits of HEPLISAV to the public.

The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the initial HEPLISAV BLA, Dynavax plans to submit a supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with chronic kidney disease.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.