DBV Technologies Begins Pivotal Peanut Allergy Study, Aims for 2026 FDA Submission.

DBV Technologies (NASDAQ:DBVT) is one of the best-performing NASDAQ stocks according to analysts. On June 25, DBV Technologies announced the screening of the first subject in its COMFORT Toddlers supplemental safety study. The study is evaluating the Viaskin Peanut patch 250 μg in peanut-allergic children between 1 and 3 years old. The announcement was made from Châtillon in France.

The COMFORT Toddlers study is a Phase 3, double-blind, and placebo-controlled/DBPC safety study. It aims to supplement existing safety and efficacy data from the previously completed Phase 3 EPITOPE study, which focused on the same patient population. The study duration is 6 months, followed by an optional 18-month open-label treatment phase. The design will allow for up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively.

A scientist wearing a lab coat looking into a microscope examining a biopharmaceutical sample.

DBV Technologies plans to enroll ~480 subjects across 80 to 90 study centers in the US, Canada, Australia, the UK, and Europe. The data generated from the COMFORT Toddlers study is expected to complete the necessary dataset for a Biologics License Application/BLA submission to the FDA. This submission is anticipated in H2 2026 under the Accelerated Approval Pathway, as previously agreed upon with the FDA.

DBV Technologies (NASDAQ:DBVT) is a clinical-stage biopharmaceutical company that researches and develops epicutaneous immunotherapy products in France.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.