USFDAJun 29, 2026, 04:01 PM
DBV Technologies Delays Peanut Patch BLA to Q3 2026 for FDA Feedback
AI Summary
DBV Technologies announced a delay in the Biologics License Application (BLA) submission for its VIASKIN® Peanut Patch for children aged 4-7 years. The company now anticipates filing the BLA in the third quarter of 2026, taking additional time to incorporate valuable feedback from the FDA regarding the organization, mapping, and formatting of existing data sets. Importantly, the FDA has not requested any additional data. DBV Technologies will host a conference call today, June 29, 2026, to discuss this update.
Key Highlights
- DBV Technologies delays BLA submission for VIASKIN® Peanut Patch.
- Anticipates submitting the BLA in the third quarter of 2026.
- Delay is to incorporate FDA feedback on data organization and formatting.
- FDA has not requested additional data for the BLA.
- Company to host a conference call on June 29, 2026, at 5:00 PM ET.
- BLA is for children aged 4 through 7 years.
Price Impact
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