DBV Technologies NASDAQ: DBVT said it is continuing preparations for a planned third-quarter 2026 Biologics License Application submission for its VIASKIN Peanut Patch in children ages 4 through 7, while also building commercial infrastructure ahead of a potential U.S. launch.
On a conference call discussing second-quarter and first-half 2026 results, Chief Executive Officer Daniel Tassé said the company is working to “transform the company into a commercial organization” in anticipation of possible FDA approval of the patch. The company’s lead program is aimed at treating peanut allergy in children.
Tassé said DBV is still optimizing its BLA submission through discussions with the FDA, which he characterized as constructive and collaborative. He emphasized that the agency has not asked for additional data.
“The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets,” Tassé said. He added that DBV plans to submit an “optimized BLA” in the third quarter of 2026 to support an efficient review.
FDA Filing Timeline and Review Expectations
During the question-and-answer portion of the call, Tassé said DBV plans to request priority review when it files the BLA because the VIASKIN Peanut platform has breakthrough designation, making the company eligible to seek that review pathway.
He said the FDA has up to 60 days after filing to accept the application for review and to determine whether priority review will be granted. DBV is currently assuming the full 60-day period, though Tassé said there is a possibility the timeline could be shorter given the level of engagement with the agency. If granted, priority review would mean a six-month review period.
On chemistry, manufacturing and controls, Tassé said discussions with the FDA are “essentially now completed” and that the agency’s comments do not require changes to how DBV manufactures the product.
“There’s nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product,” he said.
Asked what remains before submission, Tassé said the gating items are completing discussions with the FDA on CMC and on the formatting and tabulation of biostatistics tables.
Clinical Program Expands Beyond Ages 4 to 7
Chief Medical Officer Pharis Mohideen said DBV closed recruitment during the second quarter for COMFORT Toddlers, a supplemental safety study evaluating VIASKIN Peanut in toddlers ages 1 to 3. In response to an analyst question, Mohideen said the study includes a six-month treatment period and has no efficacy component.
Tassé said DBV still intends to file for the 1-to-3-year-old population by the end of 2026. He noted that EPITOPE, the pivotal trial in that age group, has already been completed and showed efficacy.
Mohideen also highlighted additional presentations from the VITESSE Phase 3 study in 4-to-7-year-olds. Data presented earlier this year at the American Academy of Allergy, Asthma & Immunology annual meeting showed consistent treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups, she said.
At the European Academy of Allergy and Clinical Immunology Congress, DBV presented data showing that children with asthma, eczema or other food allergies had no difference in VIASKIN treatment effect, according to Mohideen. She said those comorbid conditions are common in the study population and among children seen by allergists for peanut allergy.
THRIVE Study Begins in Infants
DBV is also moving into younger patients through THRIVE, a study evaluating VIASKIN Peanut in infants ages 6 through 12 months with peanut allergy. Mohideen said the first subject was enrolled last month at Dr. Doug Mack’s site in Canada.
The study is designed to assess efficacy and safety in achieving ad lib consumption of dietary peanut after three to four years of treatment with the patch. Mohideen described the trial as “first-of-its-kind” and said it is aligned with the earlier introduction of allergens into the diet and the identification of food allergies at younger ages.
In response to a question, Mohideen said THRIVE is a Phase 2, proof-of-concept study and is not intended as a registration study at this point. Tassé added that DBV chose not to wait until a post-approval Phase 4 setting because the question was “too important and too pressing.”
Commercial Preparations Underway
Chief Commercial Officer Kevin Trapp said DBV is investing across market access, patient services, brand readiness, field force planning and launch operations as it prepares for a possible U.S. launch.
Trapp said commercial planning is being coordinated across medical affairs, regulatory, pharmacovigilance, quality, supply and manufacturing teams to connect launch readiness with evidence, safety systems, product supply and the regulatory timeline.
“Our goal in the end, to ensure a prescriber and patient experience that supports their needs and fits into their daily routines,” Trapp said.
He also said DBV is engaging with caregivers, advocates, physicians and payers to better understand barriers to adoption of the peanut patch. The company is reviewing manufacturing capacity, supply chain readiness and related capital requirements that would be needed to support potential peak demand if the product is approved.
Discussing market context, Mohideen cited a recent standardized survey-based study led by Dr. Alessandro Fiocchi that reported a 2% prevalence of peanut allergy in U.S. children. She said that estimate is broadly consistent with prior U.S. literature, including an approximately 2.2% prevalence rate reported by Dr. Ruchi Gupta and colleagues in 2018.
Trapp said those findings reinforce DBV’s view that the U.S. peanut allergy opportunity has not changed and that peanut allergy remains a persistent population-level issue despite early introduction practices.
Funding Outlook
Tassé said DBV is funded into the third quarter of 2027, supporting operations and commercial preparedness, including investments across functions needed to potentially launch and support VIASKIN Peanut Patch.
He said the company is approaching investment decisions with attention to regulatory progress, commercial readiness and disciplined capital allocation.
“The first half of 2026 reinforced our conviction in DBV’s future,” Tassé said, citing progress toward BLA submission, completion of COMFORT Toddlers recruitment, expansion of the VIASKIN Peanut clinical program and preparations for commercialization.
About DBV Technologies (NASDAQ:DBVT)
DBV Technologies SA is a clinical-stage biopharmaceutical company engaged in developing immunotherapies for allergic diseases. The company specializes in epicutaneous immunotherapy, leveraging its proprietary Viaskin platform to deliver biologically active compounds across intact skin without needles or injections. Through this approach, DBV aims to modulate patients’ immune response to specific allergens, offering a potentially safer and more convenient alternative to traditional therapies.
The company’s lead product candidate, Viaskin Peanut, is designed for the treatment of peanut allergy in children and adolescents.
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