New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 18, 2014
09:18 EDTDVAXDynavax withdraws EU marketing application for HEPLISAV
Dynavax Technologies announced that it has withdrawn the European Marketing Authorization Application for HEPLISAV, its investigational hepatitis B vaccine. The Day 180 List of Outstanding Issues provided by the European Medicines Agency indicated that the current HEPLISAV safety database is considered to be too small to rule out a risk of less common serious adverse events. Dynavax has chosen to withdraw the application because the required timeframe for response under the MAA procedure is not long enough to permit the collection of the necessary clinical data. Dynavax expects to begin shortly an additional HEPLISAV clinical trial, HBV-23, that is intended to provide a safety database sufficient to support licensure.
News For DVAX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
July 22, 2015
08:17 EDTDVAXDynavax 4.55M share Spot Secondary priced at $27.50
Cowen, RBC Capital and William Blair acted as joint book running managers for the offering.
July 21, 2015
16:02 EDTDVAXDynavax files to sell common stock, no amount given
Dynavax anticipates using the net proceeds from the proposed offering to fund activities associated with completing the ongoing Phase 3 HBV-23 study of HEPLISAV-B(TM), seeking regulatory approval of HEPLISAV-B in the United States, and preparing for the anticipated U.S. commercial launch of HEPLISAV-B, should HEPLISAV-B gain approval by the Food and Drug Administration. In addition, net proceeds from the offering will support continuing the clinical development of our investigational cancer immunotherapeutic product candidate, SD-101, and for other general corporate purposes, including working capital. Cowen and Company, RBC Capital Markets and William Blair are acting as joint book-running managers for the offering.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use