DBV Technologies pushes peanut patch BLA filing to third quarter of 2026

DBV Technologies reported second quarter and half-year 2026 results on July 16, 2026, and said it now expects to submit its Biologics License Application for the VIASKIN Peanut Patch in children aged 4 through 7 with peanut allergy in the third quarter of 2026, rather than the second quarter as previously planned. The company said the FDA has not requested additional data, and DBV is incorporating feedback from the agency related to how existing chemistry, manufacturing and controls and biostatistical data sets are organized and presented, which led to the revised third-quarter filing timeline.¹

On the pipeline side, recruitment closed in the second quarter of 2026 for the COMFORT Toddlers supplemental safety study in patients aged 1 through 3 years.¹ Separately, DBV said it started the THRIVE study, which is testing whether the VIASKIN Peanut Patch can help infants aged 6 through 12 months with peanut allergy reach ad lib consumption of dietary peanut following three to four years of treatment with the patch.¹ The company also said it presented positive subgroup analyses from the phase 3 VITESSE study at the AAAAI Annual Meeting and the EAACI Congress.¹

On finances, DBV reported cash and cash equivalents of $174.9 million as of June 30, 2026.¹ The company said based on its current operations, plans and assumptions, it has enough funding to support operations for at least twelve months from the date of its Form 10-Q and Half Year Report, into the third quarter of 2027.¹ Net loss for the first half of 2026 was $98.0 million, including $50.4 million for the second quarter, compared with $69.0 million and $41.9 million for the same periods in 2025.¹