Dynavax Technologies Corporation (DVAX) Meets the FDA: All Eyes on Heplisav

The FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss the safety and efficacy of Dynavax Technologies Corporation’s (NASDAQ:DVAX) experimental hepatitis B vaccine, Heplisav, and will decide whether the vaccine merits a recommendation for approval.

Cowen analyst Phil Nadeau believes there is a 50% chance that Heplisav is recommended for approval. Nadeau rates DVAX an Outperform with a $45 price target, which represents a potential upside of 386% from where the stock is currently trading. (To watch Nadeau’s track record, click here)

The analyst shared his two cents ahead of the final vote: “We think, and our FDA consultants agree, that Heplisav’s future will be determined by whether the VRBPAC can get sufficiently comfortable with DVAX’s explanation that the CV imbalance is plausible and likely to be correct, and therefore that Heplisav can be approved with the requirement that its CV risk be further assessed through a post-market study. At least one of the FDA’s own cardiovascular consultants has adopted this view. Unfortunately, with two HBV vaccines on the market and the FDA not making any argument that it considers Heplisav’s efficacy superior, it is unclear to us whether the VRBPAC and the FDA will be comfortable assuming any risk in approving Heplisav. We continue to find the outcome of Friday’s VRBPAC meeting difficult to call, and estimate that there is a 50% chance that Heplisav is recommended for approval.”

Out of the 5 analysts polled in the past 12 months, 3 rate Dynavax stock a Hold, while 2 rate the stock a Buy. With a return potential of 103%, the stock’s consensus target price stands at $18.75.


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