DBV Technologies files BLA for Viaskin Peanut Patch in children 4-7, seeks priority review

DBV Technologies submitted its Biologics License Application to the FDA for the Viaskin Peanut Patch in children aged 4 through 7 on September 29, 2026, and requested Priority Review. The company said it submitted the BLA on that date and continued to advance its COMFORT Toddlers and THRIVE programs.¹ The application is supported by the Phase 3 VITESSE trial, which enrolled 654 children and the company describes as the largest immunotherapy trial to date in this population.¹ DBV expects the FDA's determination on whether the BLA is complete enough for full substantive review, including a decision on Priority Review, in the fourth quarter of 2026.¹

On the toddler program, aged 1 through 3 years, DBV has discussed with the FDA how to manage a timely review of that BLA following the recent 4-through-7 submission, including the possibility of a rolling submission, and the same review team is expected to handle both applications.¹ The company said it would continue those discussions over the next few months and expects to submit the toddler BLA in 2027.¹

On manufacturing, DBV continued working with contract manufacturer Fareva Amboise on remediation following an April 2026 FDA Warning Letter, saying it has visibility into remediation work specific to the Peanut Patch and that Fareva has responded to FDA on schedule with monthly updates.¹ A target date for the Pre-Approval Inspection was included in the BLA, and that date falls after when Fareva expects to finish remediation.¹

Financially, DBV reported cash and cash equivalents of $165.7 million as of September 30, 2026.¹ The company estimates this will fund operations into the third quarter of 2027.¹ Management concluded that existing cash is not expected to cover operations for at least twelve months from the financial statements' issuance date, creating substantial doubt about the company's ability to continue as a going concern within that period.¹ DBV also refreshed its $150 million ATM program and completed a $50 million gross proceeds sale of ADSs to RA Capital Management.¹