USFDAJun 29, 2026, 04:32 PM
DBV Technologies to Submit VIASKIN® Peanut Patch BLA in Q3 2026
AI Summary
DBV Technologies announced an update on its Biologics License Application (BLA) for the VIASKIN® Peanut Patch, intended for children aged 4 through 7 years. The company has been in extensive discussions with the FDA to optimize the review process, receiving valuable feedback on the organization and formatting of existing data. The FDA has not requested additional data. As a result, DBV Technologies will take additional time to incorporate this feedback and now anticipates submitting the BLA in the third quarter of 2026.
Key Highlights
- DBV Technologies provides BLA submission update for VIASKIN® Peanut Patch.
- BLA is for children aged 4 through 7 years.
- Engaged in extensive, iterative discussions with the FDA to optimize review process.
- FDA has not requested additional data for the BLA.
- Company will incorporate FDA feedback, anticipating BLA submission in Q3 2026.
- DBV Technologies will host a conference call on June 29, 2026, at 5:00 PM ET.
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