DBV Technologies S.A. reported financial results for the third quarter of 2026 and announced a significant regulatory milestone regarding its VIASKIN Peanut Patch product.
The company submitted a Biologics License Application (BLA) to the U.S. FDA for the VIASKIN Peanut Patch in children aged 4 through 7 years on September 29, 2026. The filing, supported by the Phase 3 VITESSE trial which enrolled 654 children, requested Priority Review status. The company also stated it expects to file the BLA for toddlers aged 1 through 3 years in 2027.
Regarding financial performance, DBV Technologies reported an operating income of $1.6 million for the three months ended September 30, 2026, compared to $2.8 million in the prior year. Research and development expenses totaled $47.0 million for the quarter, while sales and marketing expenses were $5.3 million. The company reported a net loss of $64.5 million for the quarter, or $0.14 per share.
As of September 30, 2026, the company held $165.7 million in cash and cash equivalents. Management estimates this cash balance will fund operations into the third quarter of 2027. However, the company noted that substantial doubt exists regarding its ability to continue as a going concern for at least twelve months, as it requires additional capital to support its operations.
DBV Technologies also refreshed its $150 million ATM program and completed a $50 million sale of American Depositary Shares to RA Capital Management during the quarter. The company continues to work with contract manufacturer Fareva Amboise to address an FDA Warning Letter issued in April 2026.
