Regulatory pushback means DBV will struggle to stay in the peanut game
DBV Technologies has been struggling to get its peanut allergy patch Viaskin Peanut across the finish line for well over a year, and its latest trip-up could prove fatal. The FDA has now asked for more data about the project’s effectiveness, specifically over whether the patch could lose potency if not stuck properly to the skin. DBV says it has that data – and can show that adhesion does not affect efficacy – but that gathering it all together could mean big delays. The project still has an August PDUFA date, though a May advisory committee hearing has been cancelled. Fortunately for the company – less so for shareholders that bought in – DBV raised €136m ($147m) in February, meaning pro forma 2020 year-end cash was €308m, which should easily stretch until next year. However, the 57% plunge in DBV stock suggests that investors will not be dipping in their pockets again. Aimmune has recently launched its rival peanut allergy offering, Palforzia, but big question remain around the commercial potential of these products. Perhaps if Palforzia is a runaway success DBV will be revived. But, in the current market, few will be willing to play the long game here.