DBV Technologies Aligns with FDA for Viaskin Peanut Approval

DBV Technologies SA – American ( (DBVT) ) has issued an announcement.

DBV Technologies has announced an alignment with the U.S. FDA on an accelerated approval pathway for its Viaskin Peanut patch, targeting toddlers aged 1 to 3 years. The company has agreed on key study elements with the FDA and plans to initiate the COMFORT Toddlers study in the second quarter of 2025. The successful communication with the FDA reduces regulatory risks for DBV, allowing the company to focus on completing studies to support Biologics License Applications (BLAs) across different age groups. The FDA’s acceptance of efficacy data from the Phase 3 EPITOPE study as an intermediate clinical endpoint marks a significant step for the Viaskin Peanut patch’s approval process. The announcement signals DBV’s potential to introduce this therapy to caregivers and patients, with implications for offering new treatment options for peanut allergies.

More about DBV Technologies SA – American

DBV Technologies SA is a clinical-stage biopharmaceutical company that focuses on developing novel treatments for food allergies, specifically through its Viaskin technology. The company’s primary product is the Viaskin Peanut patch, which is designed to treat peanut allergies in children and toddlers. DBV Technologies operates internationally and is listed on both the Euronext and Nasdaq stock markets.

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Technical Sentiment Consensus Rating: Buy

Current Market Cap: $70.76M

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