Company Update (NASDAQ:DVAX): Dynavax Announces Second Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B(TM)
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine, has completed its second prespecified review and has recommended that the study continue unchanged.
The second DSMB review included safety data for all enrolled subjects collected through the data cut-off in February. As of the cut-off, all continuing subjects had received the second immunization (which was the last active dose for HEPLISAV-B subjects) and all had reached at least 5 months follow-up after the first immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the panel recommended continuing HBV-23 with no change to the study.
One additional prespecified DSMB review will occur during the conduct of HBV-23. All study visits will be completed by October, 2015.
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
Shares of Dynavax Technologies closed last Friday at $17.6 . DVAX has a 1-year high of $20.90 and a 1-year low of $12.50. The stock’s 50-day moving average is $17.33 and it’s 200-day moving average is $15.58.
On the ratings front, Dynavax Technologies has been the subject of a number of recent research reports. In a report issued on December 12, Jefferies Co. analyst Thomas Wei reiterated a Buy rating on DVAX, with a price target of $30, which represents a potential upside of 70.5% from where the stock is currently trading. Separately, on December 11, Cowen’s Phil Nadeau maintained a Buy rating on the stock and has a price target of $60.
Dynavax Technologies Corp is a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases.