Dynavax Technologies (DVAX 17.00, +7.75, +83.8%), which is a clinical-stage immunology company, is staking an early claim at being the stock of the day. Its shares are soaring 84% after the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee voted 12 to 1 that the safety data for HEPLISAV-B -- its hepatitis B vaccine -- support licensure for immunization against hepatitis B infection in adults 18 years of age and older.
While the FDA still needs to approve HEPLISAV-B, the advisory committee's vote was music to the ears of DVAX shareholders who are cognizant that that FDA typically follows the recommendations of the advisory committees. Accordingly, there is an expectation in the huge stock move that Dynavax Technologies will soon see the commercialization of HEPLISAV-B.
There is no cure for hepatitis B, so vaccination is seen as crucial step for limiting its spread. The benefit of HEPLISAV-B in that respect is that it is administered in two does over one month versus hepatitis B vaccines currently on the market that are administered in three doses over a six-month schedule. That includes offerings from the likes of pharmaceutical giants GlaxoSmithKline (GSK 40.79, -0.14, -0.3%) and Merck (MRK 64.11, +0.42, +0.7%).
Therefore, it is thought the reduced regimen for HEPLISAV-B will increase patient compliance with the vaccination process and help limit, if not ultimately eradicate, the spread of the disease.
HEPLISAV-B has a Prescription Drug User Fee Act date of August 10, 2017. Should Dynavax win the necessary approvals, it anticipates a commercial launch of its vaccine in the U.S. in early 2018 on its own or with a commercial partner.