Mon, Mar. 23, 1:08 PM| 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.
Thu, Mar. 5, 7:19 AM
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.
Dec. 29, 2014, 7:20 AM| 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.
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.
Nov. 5, 2014, 6:20 AM
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.
Aug. 7, 2014, 1:37 PM
Aug. 7, 2014, 6:19 AM
May. 5, 2014, 9:18 AM
Mar. 10, 2014, 4:27 PM| 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)
Feb. 18, 2014, 9:13 AM
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.
DVAX vs. ETF Alternatives
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.
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