DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin Peanut Patch in Toddlers 1 – 3 Years-Old

• DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis
• COMFORT Toddlers study on-track to initiate in 2Q 2025
• Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026
• FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old
• Company to host investor webcast today at 5:00pm ET
  

DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.