Dynavax Technologies Corporation (NASDAQ:DVAX) shares are skyrocketing over 70% after the FDA VRBPAC panel voted 12-1 with 3 abstentions that the safety to date supports Dynavax’s Heplisav approval for vaccination against hepatitis B infection in adults over 18 years old.
Will the positive voting outcome lead to approval of Heplisav on its PDUFA date of August 10, 2017? Cowen analyst Phil Nadeau is definitely bullish, reiterating an Outperform rating, while raising the price target to $45 (from $30). (To watch Nadeau’s track record, click here)
However, Nadeau believes the approval likely to be delayed beyond August 10 to define a post-marketing pharmacovigilance plan: “The panelists were unanimous in their opinion that the association between Heplisav, MI and autoimmune adverse events needs to be better understood, and therefore that there should be a robust post-approval commitment. Dynavax proposed working with Kaiser Permanente in California on a 40K prospectively defined cohort study, with 20K people given Heplisav, and 20K given one of the approved vaccines. DVAX estimates the study would have 99% power to rule out a risk of 2 on CV events, and anticipates the trial could be enrolled in 12 months, with data available in about 3 years. The panel did not appear satisfied with this plan, as it worried there could be selection bias in the patients recruited, and that it could take too long to produce results. Therefore it seems that Dynavax and the FDA will need to further improve the plan to ensure that reliable data will be generated quickly, and that a definitive determination of Heplisav’s MI risk in particular can be made. We suspect that this will push Heplisav’s FDA approval beyond its August 10 PDUFA date. Nonetheless, we anticipate that this delay will be relatively short, on the order of months.”
Out of the 4 analysts polled (in the past 3 months), 3 rate Dynavax stock a Buy, while 1 rate the stock a Hold. With a return potential of nearly 102%, the stock’s consensus target price stands at $32.00.