After a long debate, Dynavax Technologies Corporation’s (NASDAQ:DVAX) hepatitis B vaccine Heplisav ended up sinking the company’s shares by nearly 70% in pre-market trading. The drug maker today announced that it has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) Heplisav .
The CRL seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.
“The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible,” said Eddie Gray, chief executive officer of Dynavax. “However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma.” (Original Source)
On the ratings front, DVAX stock has been the subject of a number of recent research reports. In a report issued on September 6, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $45, which implies an upside of 288% from current levels. Separately, on the same day, William Blair’s Y Katherine Xu maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Y Katherine Xu have a yearly average return of 4.8% and 0.7% respectively. Nadeau has a success rate of 51% and is ranked #628 out of 4209 analysts, while Xu has a success rate of 45% and is ranked #2068.
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.