Châtillon, France, September 29, 2026 DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in...

Châtillon, France, September 29, 2026 DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in...

DBV submits VIASKIN Peanut Patch for FDA approval following positive Phase 3 results in peanut-allergic children ages 4 through 7.

Reported Tuesday, Sep 29 - 6:31pm EDT (TheFly subscription required to read more.)

68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12.

DBV Technologies' VITESSE trial showed Viaskin Peanut patch effectively increases peanut tolerance in children, supporting their upcoming submission for approval to the FDA.

DBV Technologies anticipates their submission to the FDA will occur in the second half of 2026

After three years of treatment, more than 70% could tolerate about three to four peanut kernels.

DBV Technologies has screened the first participant in a pioneering trial of its peanut allergy patch for infants.

Toddlers study on-track to initiate in 2Q 2025.

DBV Technologies (Nasdaq: DBVT) reported full year 2025 results and a business update focused on advancing VIASKIN® Peanut Patch clinical programs for ages 1–7 and preparing for BLA submissions.Key facts: positive Phase 3 VITESSE topline, 2025 PIPE and ATM financings, $194.2M cash at 12/31/2025 plus $94M received January 2026, and cash runway into Q2 2027.

DBV Technologies nimmt 50 Mio. Dollar durch Aktienplatzierung ein. Die Mittel fließen in die Entwicklung des Allergie-Pflasters Viaskin.

The food allergy market landscape is advancing through a robust clinical pipeline, with key programs being developed by companies such as DBV Technologies (Viaskin [DBV712] Peanut Patch), Novartis (Remibrutinib), Aravax (PVX108), ALK-Abelló (Sublingual Immunotherapy Tablet), InnoUp Farma...

DBV Technologies (Nasdaq: DBVT) reported second quarter and half-year 2026 results, highlighting continued regulatory progress for the VIASKIN® Peanut Patch in children aged 4–7 years. The company is engaged in detailed, ongoing interactions with the FDA and now anticipates submitting its BLA in the third quarter of 2026, with no additional data requested to date.DBV closed enrollment in the COMFORT Toddlers safety study, initiated the THRIVE study in infants, and remains funded into the third quarter of 2027, supported by $174.9 million in cash and cash equivalents at June 30, 2026. For the first half of 2026, operating income was $1.6 million, operating expenses $100.1 million, and net loss $98.0 million, or $(0.23) per share, compared with a $(0.58) loss per share a year earlier. Net cash used in operating and investing activities rose to $102.6 million, reflecting increased clinical, manufacturing, and commercial readiness investments.

A French #Biotech company is stealing Wednesday’s spotlight after the company announced regulatory updates for the Viaskin Peanut patch in the United States and Europe.