DBV Technologies has submitted its Biologics License Application for the Viaskin peanut patch in children aged 4 through 7 years to the United States Food and Drug Administration and requested Priority Review, the French company said on October 28 in its third quarter update, furnished to the SEC. The application, submitted on September 29, rests on the Phase 3 VITESSE trial, which enrolled 654 children and which DBV describes as the largest immunotherapy trial conducted in this population.
The next milestone is procedural and close. The FDA’s decision on whether the application is complete enough to begin substantive review, and whether Priority Review is granted, is expected in the fourth quarter of 2026. A second application, for toddlers aged 1 through 3 years, is planned for submission in 2027, and DBV said the agency has indicated the same review team will handle both filings, which the company expects will make the second review more efficient.
Money and manufacturing are the two constraints. Cash and cash equivalents were $165.7 million at September 30, funding operations into the third quarter of 2027, and the company refreshed a $150 million at the market program and completed a $50 million sale of depositary shares to RA Capital Management. On manufacturing, its contract partner Fareva Amboise received an FDA warning letter in April 2026 and is working through remediation; DBV said Fareva has responded to the agency on schedule, and that a target date for the pre approval inspection, set after Fareva expects to finish remediation, is included in the application.
Chief executive Daniel Tassé called the quarter a defining step in DBV’s move from a clinical stage company into a commercial organization, with spending shifting accordingly: research and development expense was $47.0 million in the quarter, including $4.7 million of filing fees, while sales and marketing expense rose to $5.3 million as launch preparation expanded. The approval decision, when it comes, lands close to the end of the stated cash runway, which is what makes the Priority Review question more than a scheduling detail.