That was a rough week for investors in Dynavax Technologies Corporation (NASDAQ:DVAX), after the biotech firm announced on Monday, November 14th that it had received a Complete Response Letter (CRL) from the FDA for the Heplisav Biologics License Application (BLA). This is the second CRL the firm has been issued in reaction to its application for Heplisav, a Hepatitis B vaccine, on back of the first one the agency doled out to DVAX in 2013, requiring an additional pivotal trial.
William Blair analyst Y Katherine Xu notes, “The fastest timeline for a potential approval, if any, would be about nine months from now, by our estimation; with the cash runway at three to four quarters, the company has decided to seek a pharmaceutical or financial partner for Heplisav, while pushing the oncology programs forward on its own.”
Though the analyst reiterates an Outperform rating on shares of DVAX, she simultaneously slices the price target from $45 to $17, which denotes a 62% cut in estimated valuation.
This time around, the FDA does not require further studies to be run, the agency is asking for more in-depth information concerning the following four outstanding points: First, the FDA wants more details in regards to a numerical imbalance in cardiac events in the firm’s most recent HBV-23 pivotal trial.
Second, the agency requires additional background on adverse events of an autoimmune nature, which Xu notes “did not include questions on Bell’s palsy, a previous concern on the Street.” However, from the analyst’s perspective, “Lack of apparent concerns regarding rare serious autoimmune events is a plus, in our opinion.”
Third, DVAX must produce new analyses of the integrated safety database across different time periods, which Xu deems as potentially “beneficial,” particularly if the time between an adverse event (AE) striking compared to when the vaccine dose was last taken has a considerable gap, proving less of a likelihood that the vaccination caused the AE. Moreover, the analyst anticipates it should not take too much time for the firm to generate these analyses.
Fourth, the agency requests supplemental information on post-marketing commitments.
“We have decided to maintain our Outperform rating at this juncture because we believe there is still a good chance for Heplisav to garner eventual approval, and because the immuno-oncology program SD-101 is reading out substantial data starting in 2017, which if successful should start to be ascribed value by the Street. We have updated our model and as a result, we lower our price target to $17 from $45. Currently, our valuation does not include SD- 101 or the oncology pipeline,” Xu concludes.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, one-star analyst Y Katherine Xu is ranked #3,041 out of 4,223 analysts. Xu has a 40% success rate and loses 1.1% in her annual returns. However, when recommending DVAX, Xu earns 9.9% in average profits on the stock.
TipRanks analytics demonstrate DVAX as a Buy. Out of 3 analysts polled by TipRanks, 2 are bullish on Dynavax stock and 1 remains sidelined. With a return potential of nearly 416%, the stock’s consensus target price stands at $24.50.