Dynavax Technologies Corporation (NASDAQ:DVAX) announced that HEPLISAV-B™ (Hepatitis B Vaccine) for the prevention of hepatitis B in adults is now available for prescription in the United States.
HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) on November 9, 2017. It is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
“Dynavax is prepared and proud to launch our first product, HEPLISAV-B, in the United States,” said Eddie Gray, chief executive officer of Dynavax. “We believe the increase in the rate of infections and poor compliance with current three-shot regimens has the medical community eager for access to HEPLISAV-B for adults. Given its two-dose schedule and delivery of high rates of protection, HEPLISAV-B is an important tool for preventing hepatitis B in the United States.”
HEPLISAV-B can now be ordered through a network of distributors, which will broaden over the next few weeks. The Wholesale Acquisition Cost (WAC) for HEPLISAV-B of $115 per dose, or $230 per regimen, reflects the value HEPLISAV-B brings to the healthcare system. Dynavax is currently working with an extensive network of group purchasing organizations and government entities to ensure all patients have access to HEPLISAV-B. A list of the current distributors in the Dynavax network can be accessed by calling 1-84-HEPLISAV (1-844-375-4728).
Dynavax has begun activities to support broad reimbursement of HEPLISAV-B by insurance plans. Importantly, the American Medical Association has published a new and active Current Procedural Terminology (CPT) code for a two-dose adult hepatitis B vaccine, which was created to accommodate HEPLISAV-B’s two-dose, one-month schedule. A majority of plans currently have this unique code loaded into their claims processing systems. Some plans will require recommendation from the CDC’s Advisory Committee on Immunization Practices (ACIP) prior to covering HEPLISAV-B. The next ACIP meeting is scheduled for February 21-22, 2018. Proactive payer outreach is currently ongoing, and will include updated ACIP information specific to HEPLISAV-B as it becomes available. Dynavax has staged the deployment of its field sales team to coincide with the upcoming ACIP meeting.
Shares of Dynavax are currently at $17.95, down $0.55 or -2.97%. DVAX has a 1-year high of $24.45 and a 1-year low of $3.70. The stock’s 50-day moving average is $18.56 and its 200-day moving average is $17.51.
On the ratings front, Dynavax stock has been the subject of a number of recent research reports. In a report issued on November 10, Cowen analyst Phil Nadeau maintained a Buy rating on DVAX, with a price target of $30, which represents a potential upside of 62% from where the stock is currently trading. Similary, on November 9, Cantor’s Elemer Piros reiterated a Buy rating on the stock and has a price target of $25.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Elemer Piros have a yearly average return of 12.1% and a loss of -7.9% respectively. Nadeau has a success rate of 54% and is ranked #380 out of 4754 analysts, while Piros has a success rate of 45% and is ranked #4625.
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.