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 aÂ $31.5 million as a down payment in November for rights to Heplisav.
- here's the press release
- read the Motley Fool articleÂ for more
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