Dynavax saw its share price tumble in November after FDA advisers suggested its hepatitis B vaccine needed more data to support approval. FDA rejection followed in February, sending shares down still further. Now the stock has dropped for a third time.
After rejecting Dynavax's ($DVAX) hepatitis B vaccine Heplisav for safety issues, the FDA said it will meet with the company in 6 weeks' time to discuss a more restricted use of the vaccine.
Dynavax noted that regulators want to see further evaluation of safety in the broad age group of 18 to 70, pronouncing their concerns over the possibility of rare autoimmune events among patients taking the treatment and outlining questions on process validation and the manufacturing process.
Two weeks ago, an FDA panel dealt a blow to Dynavax Technologies, raising concerns about the safety of the company's hepatitis B vaccine, Heplisav. Shares dropped and investors tend to turn their backs on a company when stock prices go down. But is the company's future really all that grim?
An FDA panel dealt a blow to Dynavax Technologies on Thursday, raising concerns about the safety of the company's hepatitis B vaccine.
Dynavax Technologies ($DVAX) didn't get the safety nod it sought for its hepatitis B vaccine from FDA advisers Thursday, and its shares plummeted in extended trading. The Berkeley, CA-based biotech is seeking U.S. approval of the vaccine, Heplisav, which provides the developer its best shot at having a marketed product.
California's Dynavax Technologies scored a win when FDA staff said the company's Heplisav vaccine works against the contagious liver disease hepatitis B.
In addition to its recommendations about the HPV shot for boys, the CDC's Advisory Committee on Immunization Practices said diabetics under the age of 60 should get the hepatitis B vaccine. Experts
Dynavax ($DVAX), which is based in Berkeley, CA, released a new round of Phase III data on its hepatitis B vaccine, Heplisav. The data focused on specific hypo-responsive groups--males, smokers and
Despite generally positive late-stage results for its experimental hepatitis B vaccine, Heplisav, Dynavax's stock price suffered after test lots showed product inconsistencies and a loss in Q2