Dynavax shares hammered on FDA clinical hold

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 hold on the drug's development because one subject in the phase 3 trial was 'preliminarily diagnosed' with Wegener's granulomatosis, an inflammation of blood vessels that is quite uncommon." There have been no signs of the disease in other study subjects. However, the FDA's move will delay the hepatitis trial for several months. It will also impact a Phase II trial for end-stage renal disease, and two INDs for other indications. Merck, Dynavax's partner on the drug, shelled out a $31.5 million as a down payment in November for rights to Heplisav.

- here's the press release
- read the Motley Fool article for more

Related Articles:
Merck, Dynavax ink $136M deal on hep B therapy. Deal report
Dynavax pockets $30M to fund new development. Dynavax report
Dynavax stock jumps on hep B data. Dynavax report
Dynavax Hep B vaccine successful in Phase II. Dynavax report

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