Shares of Dynavax Technologies took a fresh dive this morning after the biotech announced the FDA had provided some fresh insights into the safety data it wants to see before it can approve the hepatitis B vaccine Heplisav, likely adding to the delay before the biotech can try again in seeking an approval.
Dynavax noted that regulators want to see further evaluation of safety in the broad age group of 18 to 70, pronouncing their concerns over the possibility of rare autoimmune events among patients taking the treatment and outlining questions on process validation and the manufacturing process.
Dynavax Technologies ($DVAX) didn't get the safety nod it sought for its hepatitis B vaccine from FDA advisers Thursday, and its shares plummeted in extended trading. The Berkeley, CA-based biotech is seeking U.S. approval of the vaccine, Heplisav, which provides the developer its best shot at having a marketed product.
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
Shares of Dynavax Technologies spiked 30 percent this morning after the developer announced that two early stage trials of its experimental hepatitis C drug SD-101 showed the therapy appeared safe as
Over at FierceVaccines this morning, we take a look at several key biotech developments. Dynavax Technologies' shares soared 75 percent after the FDA lifted its clinical hold on the developer's
Dynavax Technologies has landed a $10 million upfront payment and up to $200 million in milestones for each of four development programs optioned by GlaxoSmithKline. Glaxo gets an exclusive option
Dynavax and Merck announced that their hepatitis B vaccine Heplisav achieved the primary endpoint in a Phase III study. In the study, 95.1 percent of subjects who received Heplisav developed
Dynavax's shares took a beating this morning after the FDA placed a clinical hold on the company's trial of Heplisav, a hepatitis B therapy. According to the Motley Fool, "[t]he agency put the
The FDA has placed a hold on a late-stage trial of an experimental hepatitis B vaccine after one of the patients in the test was diagnosed with a rare inflammatory condition. Researchers for Merck