What happened
Shares of Dynavax Technologies (DVAX 1.82%) were vaulting 7.2% higher as of 11:44 a.m. EST on Thursday. The big jump came after the biotech announced results from an ongoing clinical study evaluating hepatitis B vaccine Heplisav-B in patients undergoing hemodialysis.
So what
As you might have guessed, Dynavax had good news from the clinical trial. The company reported a seroprotection rate (a measure of the production of antibodies that can protect against infection) of 89.3% for a four-dose regimen of Heplisav-B after 20 weeks. Dynavax also stated that interim safety data showed that its vaccine was well tolerated, with no safety issues observed in the study.
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The positive results could bode well for Heplisav-B in immunizing patients on hemodialysis. With the current standard of care, patients must receive up to eight injections. Dynavax's four-dose regimen could have a competitive advantage. Heplisav-B won approval from the U.S. Food and Drug Administration (FDA) in 2017 for preventing hepatitis B infection in adults ages 18 and over.
Now what
Dynavax doesn't expect to report full safety data from the study of Heplisav-B in dialysis patients until the end of this year. There could be a potential catalyst for the biotech stock sooner, though: Dynavax hopes to win European approval for Heplisav-B in the first half of 2021.
