Dynavax says U.S. FDA rejects its hepatitis B vaccine
Tuesday, November 15, 2016
Dynavax Technologies Corp said on Monday the U.S. Food and Drug Administration had rejected the marketing application for its hepatitis B vaccine Heplisav-B, sending the company's shares tumbling 44 percent in premarket trading.
The drug developer said it received a "complete response letter" from the FDA, seeking information about certain "adverse events" during clinical trials, among other clarifications.
Dynavax said there was no request from the FDA for additional clinical trials and there were no apparent concerns about rare serious events.
Up to Friday's close of $11.60, Dynavax's shares had dropped about 52 percent this year.
Source : reuters.com
