UPDATE: MLV & Co. Downgrades Dynavax Technologies to Hold Following Management Meetings

In a report published Monday, MLV & Co. downgraded its rating on Dynavax Technologies Corporation

from Buy to Hold. MLV noted, “After months of DVAX stock volatility and speculation as to what the immediate future of Dynavax's lead product candidate, HEPLISAV, would be, the FDA sent the company a complete response letter (CRL) regarding the prophylactic hepatitis B vaccine. This follows a vote to not approve HEPLISAV by the Vaccines and Related Biological Products Advisory Committee (AdCom) on November 15, 2012. We spoke with Dynavax management about the FDA decision and the options the company may pursue for HEPLISAV. Dynavax filed its Biologics License Application (BLA) with the FDA on April 26, 2012, for healthy adults between the ages of 18 and 70, and was planning to file a supplemental BLA for patients with chronic kidney disease (CKD) who are at increased risk of HBV and are unprotected by current vaccines following an initial approval. An application to the EMA for both healthy adults and CKD patients that was filed on July 24, 2012, remains on track and may lead to European approval by 1Q:14.” Dynavax Technologies Corporation closed on Friday at $2.97.