Dynavax Technologies Corporation (NASDAQ:DVAX) announced that the U.S. Food and Drug Administration(FDA) has accepted for review the Biologics License Application (BLA) for HEPLISAV-B™, the company’s vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date.
“This filing is another important step toward our goal of bringing HEPLISAV-B to market to protect adults against hepatitis B,” said Eddie Gray, chief executive officer for Dynavax. “We will continue to work closely with the FDA over the coming months in order to achieve HEPLISAV-B approval in the third quarter of 2016.”
The HEPLISAV-B BLA is based on positive immunogenicity results from clinical trials that have generated safety data in more than 10,000 participants. Results of these trials showed that two doses of HEPLISAV-B given one month apart provides significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B, a currently marketed hepatitis B vaccine that is administered over six months. In Phase 3 studies across all participants, HEPLISAV-B achieved peak seroprotection rates of 95.7 percent compared with 79.5 percent for Engerix-B. Additionally, in more than 1,100 participants with diabetes, HEPLISAV-B provided seroprotection rates of 90 percent compared to 65.1 percent for Engerix-B.
“Adult hepatitis B infection remains an important public health concern. If approved, HEPLISAV-B will represent the first advance in hepatitis B immunization inthe United States in more than 25 years and will offer rapid protection from hepatitis B after only two doses in just one month,” said Robert Janssen, M.D., chief medical officer and vice president, clinical development for Dynavax. “We believe HEPLISAV-B will provide a significant real-world improvement over currently marketed hepatitis B vaccines.” (Original Source)
Shares of Dynavax Technologies opened today at $18.05. DVAX has a 1-year high of $32.49 and a 1-year low of $15.52. The stock’s 50-day moving average is $17.88 and its 200-day moving average is $23.30.
On the ratings front, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $60, in a report issued on January 7. The current price target represents a potential upside of 232.4% from where the stock is currently trading. According to TipRanks.com, Nadeau has a yearly average return of -2.5%, a 33.3% success rate, and is ranked #3096 out of 3766 analysts.
Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company that uses toll-like receptor TLR biology to discover and develop novel vaccines and therapeutics. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. Its lead product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. The company’s other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy. Dynavax Technologies was founded by Lawrence M. Lichtenstein, Dennis A. Carson and Eyal Raz on August 29, 1996 and is headquartered in Berkeley, CA.