Wall Street is trading slightly in the green with the three indexes up around 0.2%. Among today's gainers, Dynavax Technologies Corp. (DVAX, Financial) is in the spotlight.
On Friday, the company announced the Food and Drug Administration voted 12 to one in support of the company’s hepatitis B vaccine Heplisav, which immunizes against the infection in adults. Previously, an advisory committee voted almost unanimously (13 to one) that data from Phase 3 clinical trials support the immunogenicity of Heplisav. The stock closed at $9.25 on Friday and has gained about 85% in pre-market trading on Monday.
"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," Eddie Gray, CEO of Dynavax, said. "Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection. In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review."
Moreover, analysts at JPMorgan (JPM, Financial) upgraded the stock to overweight with a $27 price target. Analysts at RBC Capital Markets upgraded to outperform with a $26 price target. On a year-to-date basis, Dynavax shares have surged 128% to $9.25 from $4.05.
Disclosure: The author holds no position in any stocks mentioned.
