Shares of Dynavax Technologies (DVAX) spiked 21 percent this morning after the developer announced that its experimental hepatitis B vaccine Heplisav proved to be as safe as GSK's recently approved Engerix-B. Researchers say they saw no difference between the autoimmune responses in patients taking either Heplisav or the GSK vaccine.
"Our retrospective analysis of clinical and laboratory safety from 2,500 Heplisav-vaccinated subjects in nine clinical trials provided no evidence of an increased risk of autoimmune disease. This thorough analysis has been discussed with the FDA and demonstrates that the safety profile of Heplisav is no different from that of Engerix-B, one of the safest vaccines on the market today," says Dynavax CMO Dr. Tyler Martin.
The FDA removed a clinical hold on the vaccine's program last fall, and it is now in late-stage trials. The retrospective safety data was originally gathered to present to regulators engaged in the clinical hold.
- check out the press release
- here's the story from Reuters