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 and Dynavax Technologies halted the study, but noted that none of the other 2,500 patients treated with Heplisav in 10 clinical trials reported the same condition, which causes blood vessels to become inflamed. Dynavax shares shed 43 percent of their value on the news.
- see this release [1]
- read the AP report [2]
- here's the AFX story [3]
Related Articles:
Merck, Dynavax ink $136M deal on hep B therapy. Report [4]
Dynavax stock jumps on hep B data. Report [5]
Dynavax Hep B vaccine successful in Phase II. Report [6]
Links:
[1] http://www.fiercebiotech.com/press-releases/dynavax-technologies-corporation-merck-says-fda-puts-clinical-hold-hepatitis-b-drug
[2] http://www.forbes.com/feeds/ap/2008/03/17/ap4783950.html
[3] http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-23835332.htm
[4] http://www.fiercebiotech.com/story/merck-dynavax-ink-136m-deal-hep-b-therapy/2007-11-01
[5] http://www.fiercebiotech.com/story/dynavax-stock-jumps-on-hep-b-data/2006-11-29
[6] http://www.fiercebiotech.com/story/dynavax-hep-b-vaccine-successful-in-phase-ii/2006-12-04