Dynavax Technologies Corporation (NASDAQ:DVAX) has won U.S. Food and Drug Administration approval for its hepatitis B vaccine, HEPLISAV, ending a more than nine-year effort to bring the vaccine to the market.
Dynavax shares reacted to the FDA approval, rising nearly 16% to $23.25 in after-hours trading.
Dynavax CEO commented, "HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization [...] We would like to thank the many study participants and clinical trial investigators who contributed to the development of HEPLISAV-B. We expect that it will become an essential tool in the public health community's fight to prevent hepatitis B, and we look forward to making HEPLISAV-B available to clinicians and their adult patients."
Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.(i) Hepatitis B can be prevented through effective vaccination. Current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year.(ii)
"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, M.D., professor of Preventive Medicine, Vanderbilt University Medical Center. "Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States."
The approval of HEPLISAV-B was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adult participants (18 years and older) who received HEPLISAV-B. The pivotal studies compared HEPLISAV-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis of 961 participants with Type 2 diabetes, HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).
Dynavax expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.
On the ratings front, Dynavax has been the subject of a number of recent research reports. In a report issued on November 3, Cowen analyst Phil Nadeau assigned a Buy rating on DVAX, with a price target of $30, which represents a potential upside of 50% from where the stock is currently trading. Similarly, on October 29, RBC's Matthew Eckler reiterated a Buy rating on the stock and has a price target of $28.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Matthew Eckler have a yearly average return of 11.6% and 7.7% respectively. Nadeau has a success rate of 51% and is ranked #382 out of 4707 analysts, while Eckler has a success rate of 53% and is ranked #1983.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $28 which is 40% above where the stock closed today.
Dynavax is a clinical-stage biopharmaceutical company that uses toll-like receptor 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 firm's other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy.
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