On Tuesday, DBV Technologies ( DBVT ) announced progress in its regulatory efforts for the Viaskin Peanut patch, aimed at treating peanut allergies in toddlers and children.

The company has aligned with the FDA under the Accelerated Approval Program for toddlers aged 1–3.

DBV has agreed to the FDA’s guidance on key study components required for approval, including the COMFORT Toddlers safety study, which must be completed before the US marketing application submission, and a confirmatory study to demonstrate the patch’s effectiveness.

DBV plans to begin enrolling subjects in the COMFORT Toddlers study in the second quarter of 2025, with around 300–350 toddlers.

DBV has also made headway on the Viaskin Peanut patch for older children. In September 2024, the company completed patient screening for the Phase 3 VITESSE trial, enrolling 654 children aged 4–7 years. Topline data are expected in the fourth quarter of 2025.

Discussions between DBV and the FDA have also addressed the patch’s adhesion issues. The company proposed a labeling solution that links adhesion data to the patch’s efficacy and safety.

DBV also received scientific advice from the European Medicines Agency for a broader age range of 1–7 years in Europe.

In Europe, DBV has received scientific advice confirming that the EPITOPE study in 1–3-year-olds and positive results from the VITESSE study could support the European marketing application for the 1–7-year-old age group.

The company is planning a new safety study for toddlers with the modified patch to meet European requirements.

Despite its clinical progress, DBV’s financial situation raises concerns. The company reported cash and cash equivalents of $46.4 million as of September 30, 2024, and anticipates that this will fund operations only through the first quarter of 2025.

With ongoing operating losses, DBV has expressed uncertainty about its ability to continue operations without securing additional funding. The company is actively seeking new capital to support its research and potential product launch.

Price Action: DBVT stock is up 44.3% at $1.02 at last check Wednesday.

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