FierceBiotech FierceBiotech IT FiercePharma FierceMedicalDevices
FierceBiotech Research FierceVaccines FiercePharma Manufacturing FierceDrugDelivery

Free Newsletter

About | View Sample | Privacy
Related Topics >> Dynavax | Heplisav | hepatitis B

Dynavax gets green light to resume hep B vax program

Free Newsletter

FierceVaccines is a weekly update on the vaccine industry, with a special focus on the innovations revolutionizing the development and production of vaccines. Join thousands of lab research professionals who get FierceVaccines via weekly email. Sign up today!


The FDA is giving Dynavax Technologies a green light to resume testing of a late-stage hepatitis B vaccine that had been derailed 18 months ago after a patient in one study developed a rare inflammatory autoimmune disease. The regulatory approval will pave the way to a new Phase III trial that compares the effects of a commercially manufactured version of Heplisav with the vaccine used in clinical trials to ensure uniformity. And the CEO of the company says that if everything now stays on track, a new hep B vaccine could be on the market in 2012.

The FDA's move to halt the study of Heplisav dealt a severe wound to the developer. Last fall its stock had fallen to a meager 15 cents a share, a steep plunge from the year before, when it was worth $10 a share. Soon after the news hit the wires that the FDA was lifting its clinical hold, Dynavax's shares surged 36 percent--to $2.39--as investors got a chance to consider the new potential of Heplisav.

The vaccine combines an antigen and an adjuvant designed to target toll-like receptor 9, which spurs the human immune system into action. New late-stage trials will include a Phase III for adults over the age of 40. The market for hep B vaccines is around $500 million worldwide.

- read the story from Reuters
- check out the story from Dow Jones

Related Articles:
Dynavax explores new strategy for Heplisav
Merck, Dynavax announce Heplisav results
Dynavax shares hammered on FDA clinical hold
Rare disease puts Phase III vax trial on hold
Merck, Dynavax ink $136M deal on hep B therapy

Email Twitter Facebook LinkedIn StumbleUpon
Get Your FREE FierceVaccines Email Newsletter:
Be the first to comment
More stories about Dynavax   Heplisav   hepatitis B  


Post new comment

The content of this field is kept private and will not be shown publicly.

More information about formatting options

This question is for testing whether you are a human visitor and to prevent automated spam submissions.