We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Dynavax (DVAX) Shares Jump 75% after FDA Committee Approval
Read MoreHide Full Article
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.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade, which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Dynavax (DVAX) Shares Jump 75% after FDA Committee Approval
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.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade, which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>