DBV Technologies Posts Wider Q3 Loss as VIASKIN Peanut Patch BLA Advances Toward FDA Review
DBV Technologies (DBVT) reported a third-quarter 2026 net loss of $64.5 million, or $0.14 per share, widening from $33.2 million, or $0.24 per share, a year earlier, as spending surged on the regulatory submission and commercial preparations for its VIASKIN Peanut Patch. The company submitted a Biologics License Application to the FDA on September 29, 2026, seeking approval for the patch in children aged 4-7 with peanut allergy, supported by the 654-patient Phase 3 VITESSE trial, and requested Priority Review. The FDA's decision on whether to accept the application is expected in the fourth quarter of 2026. R&D expense rose to $47.0 million from $28.6 million, while sales and marketing costs climbed to $5.3 million from $1.2 million. Cash and equivalents stood at $165.7 million as of September 30, expected to fund operations into the third quarter of 2027. Shares closed Wednesday's trading at $10.65, up 5.19%, before falling 12.86% to $9.28 in pre-market trading.