Latest Headlines

Latest Headlines

Analyst: Dynavax hep B vaccine positioned to grab market share from GSK's Engerix-B

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.

Dynavax initiates PhIII study it hopes will quell FDA's safety concerns

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.

Dynavax's hep B vaccine plans derailed by European request for extra safety data

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.

FDA setback sends Dynavax shares tumbling again

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 rejection, Dynavax to shoot for limited hep B vaccine approval

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.

Can Dynavax overcome Heplisav blow?

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?

FDA panel concerned about safety of Dynavax's hep B vaccine

An FDA panel dealt a blow to Dynavax Technologies on Thursday, raising concerns about the safety of the company's hepatitis B vaccine.

FDA: Dynavax's Heplisav effective against hepatitis B

California's Dynavax Technologies scored a win when FDA staff said the company's Heplisav vaccine works against the contagious liver disease hepatitis B.

HepB vax Heplisav posts positive Ph3 data

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

Dynavax's Heplisav performs well, but shows product inconsistency

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