Dynavax Technologies Corporation (NASDAQ:DVAX) announced that the U.S. Food and Drug Administration(FDA) will require additional time to complete its review of the Biologics License Application (BLA) for HEPLISAV-B™, Dynavax’s investigational vaccine for immunization of adults against hepatitis B infection. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) action date for HEPLISAV-B has been extended by three months to December 15, 2016.
On April 8, in response to an FDA request, Dynavax submitted individual trial data sets that had been provided as integrated data in the March 2016 BLA resubmission. FDA then determined that the addition of these large data sets represented a major amendment to the BLA and thus extended the PDUFA action date to allow for a full review.
The HEPLISAV-B BLA is based on results from clinical trials that have generated data in more than 14,000 total participants.
“We appreciate the commitment of the FDA staff to conduct a complete review of all of the data supporting our BLA and we remain committed to working closely with them over the coming months in order to achieve HEPLISAV-B approval in 2016,” said Eddie Gray, chief executive officer of Dynavax. (Original Source)
Shares of Dynavax closed yesterday at $20.98, down $0.63 or -2.92%. DVAX has a 1-year high of $32.49 and a 1-year low of $15.52. The stock’s 50-day moving average is $19.56 and its 200-day moving average is $22.41.
On the ratings front, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $60, in a report issued on January 7. The current price target implies an upside of 186.0% from current levels. According to TipRanks.com, Nadeau has a yearly average return of 4%, a 49% success rate, and is ranked #794 out of 3829 analysts.
Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company that uses toll-like receptor TLR biology to discover and develop novel vaccines and therapeutics. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. Its lead product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. The company’s other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy. Dynavax Technologies was founded by Lawrence M. Lichtenstein, Dennis A. Carson and Eyal Raz on August 29, 1996 and is headquartered in Berkeley, CA.