Dynavax Technologies Corp. (DVAX - Free Report) shares rocketed 75% in morning trading on Monday after a Food and Drug Administration committee approved the company’s hepatitis B vaccination.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 12 to 1 on the safety data for Dynavax’s vaccine, Heplisav-B, determining that it is safe when administered to adults 18 years and older.
The FDA has rejected Heplisav-B twice before, citing unresolved safety concerns. FDA staffers said the experimental vaccine is now safe and effective, although patients who took Dynavax’s product experienced more deaths and serious health problems than those who took a rival product.
“We are encouraged by the committee’s positive vote in favor of Heplisav-B, which we believe will become an important new tool in the fight against hepatitis B infection if approved by the FDA,” said Eddie Gray, the CEO of Dynavax. “We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes the review.”
Dynavax designed Heplisav-B to strengthen the body’s immune system to fight the hepatitis B virus, which can cause cirrhosis of the liver, cancer, and even death. The virus spreads through sexual contact, sharing of needles and from mother to child during pregnancy. There is no cure.
Current hepatitis B vaccines are given in three doses over six months. Heplisav-B would be administered in two doses during a one-month period, which would make it a more popular option.
The FDA is expected to approve the vaccine in August, although it is not bound to follow the advice of its advisory panels. If approved, Dynavax will launch Heplisav-B in the U.S. in early 2018.
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