DBV Technologies Shares Jump On Positive Data From Peanut Allergy Trial In Toddlers

DBV Technologies SA's DBVT pivotal Phase 3 EPITOPE trial of Viaskin Peanut 250 µg for peanut-allergic toddlers ages 1 to 3 years met its primary endpoint.
Viaskin Peanut demonstrated a statistically significant treatment effect, with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, compared to 33.5% of subjects in the placebo arm.
DBV continues a productive dialogue with the FDA on the Phase 3 VITESSE trial protocol of the modified Viaskin Peanut patch in peanut-allergic children ages four years and older.
Related: DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low.
In an additional pre-specified efficacy analysis, Viaskin Peanut demonstrated a statistically significant treatment effect, with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder criterion after 12 months compared to 29.6% of subjects in the placebo arm.
The safety results were generally consistent with the safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages four years and older in prior clinical trials.
No imbalance in the overall adverse event rate was observed between the active and placebo arms in the trial.
Price Action: DBVT shares are up 15.03% at $1.53 during the premarket session on the last check Wednesday.