Initially approved by the FDA in 1989, GlaxoSmithKline's Engerix-B has been the standard-of-care against hepatitis B. But an analyst thinks Dynavax's experimental Heplisav is poised to swipe some market share once it's approved.
FDA and EMA requests for more data on hepatitis B candidate Heplisav have set Dynavax Technologies back time and again. Now, Dynavax is embarking on a new trial it hopes will address some of those safety concerns.
Last week research firm GlobalData tipped the hepatitis B vaccine market to top $1 billion by 2022, with sales of Sanofi's Hexyon driving the sector's modest growth. Dynavax hopes to claim a slice of the market too, but its hepatitis B vaccine received another blow this week.
Dynavax saw its share price tumble in November after FDA advisers suggested its hepatitis B vaccine needed more data to support approval. FDA rejection followed in February, sending shares down still further. Now the stock has dropped for a third time.
After rejecting Dynavax's ($DVAX) hepatitis B vaccine Heplisav for safety issues, the FDA said it will meet with the company in 6 weeks' time to discuss a more restricted use of the vaccine.
Two weeks ago, an FDA panel dealt a blow to Dynavax Technologies, raising concerns about the safety of the company's hepatitis B vaccine, Heplisav. Shares dropped and investors tend to turn their backs on a company when stock prices go down. But is the company's future really all that grim?
An FDA panel dealt a blow to Dynavax Technologies on Thursday, raising concerns about the safety of the company's hepatitis B vaccine.
California's Dynavax Technologies scored a win when FDA staff said the company's Heplisav vaccine works against the contagious liver disease hepatitis B.
Dynavax ($DVAX), which is based in Berkeley, CA, released a new round of Phase III data on its hepatitis B vaccine, Heplisav. The data focused on specific hypo-responsive groups--males, smokers and
Despite generally positive late-stage results for its experimental hepatitis B vaccine, Heplisav, Dynavax's stock price suffered after test lots showed product inconsistencies and a loss in Q2