Post by Chuck-2 on Jul 4, 2016 15:25:56 GMT
Dynavax Hepatitis B Vaccine Beats Glaxo's In Trial
IT12-DVAX-010816-iStock
AMY REEVES1/07/2016
Biotech Dynavax Technologies (DVAX) soared Thursday, even as the market overall crashed, after its hepatitis B vaccine beat GlaxoSmithKline's (GSK) standard product in a late-stage clinical trial.
Dynavax said that its vaccine, Hepislav-B, showed a 95.4% rate of peak seroprotection, in contrast with only 81.3% for Glaxo's Engerix-B. Dynavax focused especially on patients with diabetes mellitus, who don't respond well to current vaccines and treatments. In the study, the seroprotection rate for Hepislav-B was 90%, as opposed to Engerix-B's 65.1%.
The study also showed that the two vaccines had similar safety profiles. A number of adverse events occurred in both arms, mostly autoimmune-related, but Dynavax said that they were not related to vaccinations.
Dynavax said that it will file for U.S. approval of Hepislav-B by the end of this quarter. Dynavax had already tried and failed to win approval in 2013, but the company says that it's now addressed all the issues that the FDA raised at the time.
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Dynavax stock was up nearly 30% in afternoon trading on the stock market today, near 27.50.
William Blair analyst Katherine Xu raised her price target on Dynavax stock to 45 from 42 while maintaining her outperform rating.
"We maintain our estimate for a Heplisav launch in the United States in third quarter 2016 in the full adult population, with $600 million in peak sales eight years into launch," Xu wrote in her research note. "We expect potential approval in Europe to occur in 2019 after post-marketing studies to expand the safety database."
RBC Capital Markets analyst Simos Simeonidis was also positive on approval prospects but expressed slight concern about safety.
"(The) autoimmune debate/overhang (was) not completely put to rest," Simeonidis wrote in his research note. "There was an imbalance of new-onset autoimmune events in the trial: 8 in Heplisav arm vs. 1 in Engerix arm. Management mentioned that in the overall safety dataset, this imbalance is not there."
Dynavax still isn't expected to turn a profit until 2018, as it does not have any other products out yet. The company is developing a cancer therapy as well as an asthma treatment in collaboration with AstraZeneca (AZN).
Follow Amy Reeves on Twitter @ibd_Areeves and on Facebook.
IT12-DVAX-010816-iStock
AMY REEVES1/07/2016
Biotech Dynavax Technologies (DVAX) soared Thursday, even as the market overall crashed, after its hepatitis B vaccine beat GlaxoSmithKline's (GSK) standard product in a late-stage clinical trial.
Dynavax said that its vaccine, Hepislav-B, showed a 95.4% rate of peak seroprotection, in contrast with only 81.3% for Glaxo's Engerix-B. Dynavax focused especially on patients with diabetes mellitus, who don't respond well to current vaccines and treatments. In the study, the seroprotection rate for Hepislav-B was 90%, as opposed to Engerix-B's 65.1%.
The study also showed that the two vaccines had similar safety profiles. A number of adverse events occurred in both arms, mostly autoimmune-related, but Dynavax said that they were not related to vaccinations.
Dynavax said that it will file for U.S. approval of Hepislav-B by the end of this quarter. Dynavax had already tried and failed to win approval in 2013, but the company says that it's now addressed all the issues that the FDA raised at the time.
Get instant access to exclusive stock lists and powerful tools on Investors.com. Try us free for 4 weeks.
Get instant access to exclusive stock lists and powerful tools on Investors.com. Try us free for 4 weeks.
Dynavax stock was up nearly 30% in afternoon trading on the stock market today, near 27.50.
William Blair analyst Katherine Xu raised her price target on Dynavax stock to 45 from 42 while maintaining her outperform rating.
"We maintain our estimate for a Heplisav launch in the United States in third quarter 2016 in the full adult population, with $600 million in peak sales eight years into launch," Xu wrote in her research note. "We expect potential approval in Europe to occur in 2019 after post-marketing studies to expand the safety database."
RBC Capital Markets analyst Simos Simeonidis was also positive on approval prospects but expressed slight concern about safety.
"(The) autoimmune debate/overhang (was) not completely put to rest," Simeonidis wrote in his research note. "There was an imbalance of new-onset autoimmune events in the trial: 8 in Heplisav arm vs. 1 in Engerix arm. Management mentioned that in the overall safety dataset, this imbalance is not there."
Dynavax still isn't expected to turn a profit until 2018, as it does not have any other products out yet. The company is developing a cancer therapy as well as an asthma treatment in collaboration with AstraZeneca (AZN).
Follow Amy Reeves on Twitter @ibd_Areeves and on Facebook.
