Seeking Alpha
 

Dynavax Technologies Corporation (DVAX)

- NASDAQ
  • Mon, Mar. 23, 1:08 PM
    • Thinly-traded small cap Dynavax (DVAX +11.4%) heads north on 73% higher volume albeit on only 658K shares. Earlier today, JP Morgan upgraded it to "Overweight" with a $36 price target, implying a 44% upside based on improved prospects for its hepatitis B vaccine Heplisav-B.
    | 2 Comments
  • Thu, Mar. 5, 9:33 AM
    • Dynavax Technologies (DVAX -0.3%) Q4 results: Revenues: $2.3M (-17.9%); R&D Expense: $19.6M (+62.0%); SG&A: $5.1M (+37.8%); Operating Loss: ($22.4M) (-72.3%); Net Loss: ($22.3M) (-70.2%); Loss Per Share: ($0.85) (+6.6%).
    • FY2014 results: Revenues: $11M (-2.7%); R&D Expense: $84.6M (+66.2%); SG&A: $17.4M (-32.8%); Operating Loss: ($91.3M) (-37.3%); Net Loss: ($90.7M) (-36.0%); Loss Per Share: ($3.45) (+9.9%); Quick Assets: $122.7M (-35.2%).
    • No guidance given.
    | Comment!
  • Thu, Mar. 5, 7:19 AM
    • Dynavax (NASDAQ:DVAX): Q4 EPS of -$0.85 beats by $0.11.
    • Revenue of $2.27M (-20.4% Y/Y) misses by $0.09M.
    • Press Release
    | Comment!
  • Mon, Mar. 2, 5:39 PM
    • After completing its second prespecified review of safety data from the Phase 3 trial evaluating Dynavax Technologies' (NASDAQ:DVAX) hepatitis B vaccine candidate, Heplisav-B, the independent Data and Safety Monitoring Board (DSMB) recommends that the study continue unchanged.
    • The second DSMB review included safety data for all subjects through the February data cut-off date. All continuing subjects had received the second immunization (the last active dose of the vaccine) and all reached at least five months follow-up after the first immunization.
    • The DSMD will review the safety data a third and final time before the end of the trial. All study visits will be completed by October.
    • Heplisav-B combines a toll-like receptor 9 (TLR9) agonist with hepatitis B surface antigen to elicit an immune response after just two doses. A TLR9 agonist is an adjuvant which boosts the immune system.
    | 1 Comment
  • Dec. 29, 2014, 7:20 AM
    • Dynavax Technologies Corp. (NASDAQ:DVAX) enters into a $40M credit facility with Hercules Technology Growth Capital (NYSE:HTGC). It has already drawn $10M and has access to the additional $30M contingent on achieving certain milestones regarding the ongoing Phase 3 trial of Heplisav-B.
    | Comment!
  • Dec. 8, 2014, 10:55 AM
    • Funded by collaboration partner AstraZeneca (AZN +0.1%), Dynavax (DVAX +2.9%) will initiate a Phase 2a study in 1H 2015 to evaluate AZD1419 in asthmatic patients. Dynavax will earn a milestone payment from AZN when this occurs. Remaining milestones could be as much as $100M.
    • AZD1419 is a second-generation TLR9 agonist CpG oligodeoxynucleotide for inhalation use.
    | Comment!
  • Nov. 28, 2014, 7:41 AM
    • GlaxoSmithKline (NYSE:GSK) declines to exercise its option to license Dynavax's (NASDAQ:DVAX) DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its pharmacodynamic endpoints related to the reduction in interferon alpha-regulated genes in a Phase 1b/2a study in patients with active systemic lupus erythematosus.
    • Dynavax will now have full global rights to develop DV1179 and other TLR 7/9 inhibitors for all indications.
    | Comment!
  • Nov. 5, 2014, 6:20 AM
    • Dynavax (NASDAQ:DVAX): Q3 EPS of -$0.11 misses by $0.02.
    • Revenue of $2.9M (-1.0% Y/Y) beats by $0.39M.
    • Press Release
    | Comment!
  • Sep. 22, 2014, 8:13 AM
    • Dynavax Technologies Corp. (NASDAQ:DVAX) completes patient enrollment in the ongoing Phase 3 clinical trial of its investigational hepatitis B vaccine, Heplisav-B. More than 8,250 adults, including over 1,100 diabetics, have been enrolled at 40 sites in the U.S.
    • The large safety and immunogenicity study is intended to provide the FDA sufficient data to enable it to complete its review of Heplisav-B's BLA. The study will also assess Heplisav-B's efficacy in adults for whom currently-approved hep B vaccines are less effective, such as those with type 2 diabetes.
    • Adult subjects have been randomized in a 2:1 ratio to receive a two-dose series of Heplisav-B or a three-dose series of Glaxo's (NYSE:GSK) Engerix-B. Safety follow-up will continue for 12 months after each patient's second vaccination. All study visits will be completed by October 2015.
    | 2 Comments
  • Aug. 7, 2014, 1:37 PM
    • Dynavax Technologies (DVAX -4.9%) Q2 results: Revenues: $3.0M (-10.1%); Operating Expenses: $27.9M (+36.8%); Operating Loss: ($24.9M) (-46.5%); Net Loss: ($24.8M) (-44.2%); Loss Per Share: ($0.09) (unch); Quick Assets: $154.3M (-18.5%).
    • No guidance given.
    | Comment!
  • Aug. 7, 2014, 6:19 AM
    • Dynavax (NASDAQ:DVAX): Q2 EPS of -$0.09 misses by $0.03.
    • Revenue of $3.04M (-10.3% Y/Y) beats by $0.78M.
    • Press Release
    | Comment!
  • May. 5, 2014, 9:18 AM
    • Dynavax (DVAX): Q1 EPS of -$0.05 beats by $0.01.
    • Revenue of $3.49M (+67.8% Y/Y) misses by $0.22M.
    • Press Release
    | Comment!
  • Mar. 10, 2014, 4:27 PM
    • Dynavax Technologies Corporation (DVAX): Q4 EPS of -$0.09 misses by $0.02.
    • Revenue of $2.84M (+56.9% Y/Y) beats by $1.28M.
    • Press Release
    | Comment!
  • Feb. 18, 2014, 9:56 AM
    • Dynavax (DVAX +1.7%) withdraws its application for the European approval of the company's Hepatitis B vaccine Heplisav after the European Medicines Agency (EMA) indicated that the product's safety database is too small to rule out the risk of less common serious side-effects.
    • Dynavax plans to soon start another Heplisav trial in order to provide a large enough database. (PR)
    | 3 Comments
  • Feb. 18, 2014, 9:13 AM
    | 1 Comment
  • Jan. 22, 2014, 6:45 PM
    • Better late than never, Cowen analysts seem to say as they recommend their top biotech names even after four straight years of sector outperformance against the S&P 500.
    • Amgen (AMGN) is one of the big-cap biotechs Cowen thinks will handily beat this year’s earnings estimates.
    • Biogen (BIIB) remains the top name in class, and the firm thinks the stock is not overvalued at 20x 2015 earnings; Cowen also believes BIIB can beat this year’s earnings expectations.
    • Nektar Therapeutics (NKTR) is a top name to buy due to its impressive clinical pipeline and list of big pharma partners; despite having eight late-stage candidates, NKTR’s market cap is just $1.3B.
    • Also named: ACOR, BMRN, CELG, CMRX, DVAX, IMGN, PTLA, VVUS.
    | 1 Comment
Visit Seeking Alpha's
DVAX vs. ETF Alternatives
Company Description
Dynavax Technologies Corp is a clinical-stage biopharmaceutical company. The Company is engaged in thedevelopment for the prevention of infectious disease, the treatment of autoimmune and inflammatory diseases, and the treatment of cancer.