Biotech Values

[DewDiligence]

From same DBVT—(-60%/AH)—PR:

DBV Technologies…today announced topline results from the PEPITES (Peanut EPIT Efficacy and Safety) Phase III trial evaluating the safety and efficacy of Viaskin Peanut in children four to 11 years of age. Topline results show a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 µg after 12 months of treatment as compared to 13.6% of patients in the placebo arm (difference in response rates = 21.7%; p=0.00001; 95% CI = 12.4% - 29.8%).

However, the primary endpoint, which evaluates the 95% confidence interval (CI) in the difference in response rates between the active and placebo arms, did not reach the 15% lower bound of the CI that was proposed in the study’s Statistical Analysis Plan submitted to the U.S Food and Drug Administration. Following initial conversations with the FDA on these topline efficacy and safety results, DBV will continue ongoing discussions with the agency, and plans to proceed with the BLA preparation process.

Given the FDA approval of PTLA's Bevyxxa (which also missed the primary endpoint), it makes perfect sense for DBVT to file, IMO.