NEW YORK (TheStreet) -- Shares of Dynavax TechnologiesCorp. (DVAX) - Get Report are gaining by 6.98% to $19.31 on Thursday afternoon, as the FDA accepted for review its application for HEPLISAV-B, the company's vaccine candidate for immunization against hepatitis B infection in adults ages 18 years and older.
The FDA has established September 15 as the Prescription Drug User Fee Act (PDUFA) action date, according to a company statement after the market close yesterday.
"This filing is another important step toward our goal of bringing HEPLISAV-B to market to protect adults against hepatitis B," CEO Eddie Gray stated.
"We will continue to work closely with the FDA over the coming months in order to achieve HEPLISAV-B approval in the third quarter of 2016," he added.
Hepatitis B is a viral disease of the liver that can become chronic and result in cirrhosis of the liver, hepatocellular carcinoma and death.
Dynavax is a clinical-stage biopharmaceutical company based in Berkeley, CA.
Separately, TheStreet Ratings Team has a "Sell' rating with a score of D on the stock.
This is driven by some concerns, which we believe should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks covered by the team.
The company's weaknesses can be seen in multiple areas, such as its deteriorating net income and generally disappointing historical performance in the stock itself.
Recently, TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this articles's author.
You can view the full analysis from the report here: DVAX