Clinical Trial Outcomes Risk: The success of the company is highly dependent on the outcomes of its ongoing and future clinical trials for Viaskin, particularly for peanut allergy. Failure to achieve primary endpoints or demonstrate sufficient efficacy and safety could lead to delays, abandonment of development, or inability to gain regulatory approval.

Regulatory Approval Uncertainty: There is no guarantee that Viaskin will receive or maintain regulatory approvals from agencies like the FDA or EMA, even if clinical trials are successful. Regulatory bodies may require additional studies, impose restrictions, or deny approval based on their assessment of the data.

Commercialization and Market Adoption Challenges: Even if Viaskin products are approved, DBV Technologies may face significant hurdles in commercializing them, including market acceptance by physicians and patients, establishing distribution channels, achieving favorable pricing and reimbursement, and competing effectively in a crowded market.