DBV Technologies (NASDAQ:DBVT) CEO Daniel Tassé outlined the company’s near-term regulatory plans, clinical results, and commercialization strategy for Viaskin Peanut, a skin patch being developed to treat peanut allergy in young children, during a recent discussion focused on the food allergy market.
Two BLA filings planned for Viaskin Peanut
Tassé said DBV is preparing to file two biologics license applications (BLAs) for Viaskin Peanut. The first filing, for children ages four to seven, is targeted for mid-2026, with Tassé specifying a submission by June 30. A second “sister” BLA for children ages one to three—the company’s toddler program—is planned by the end of 2026.
How Viaskin works: delivering allergen via the skin
Tassé described Viaskin as a patch-based platform designed to exploit the immune properties of skin. The patch delivers “microgram amounts” of allergen to the skin, where Langerhans cells (antigen-presenting cells) recruit the allergen and help mobilize a regulatory T-cell (Treg) response. According to Tassé, this mechanism is intended to desensitize patients against reactions to accidental consumption of the allergen.
He positioned IgE blockade and allergen desensitization as two broad approaches in food allergy. In his view, IgE blockade blunts reactions during exposure while treatment continues, whereas desensitization is intended to be disease-modifying over longer treatment periods, with the goal of sustained unresponsiveness.
VITESSE trial and pediatric efficacy discussion
In the four-to-seven-year-old program, Tassé pointed to VITESSE as a key registration study and said it was the largest trial performed in peanut allergy, enrolling 654 patients randomized 2-to-1 active to placebo. He said the FDA expects roughly 600 patients treated for at least six months for the safety database, and he highlighted DBV’s approach of crossing placebo patients over to active treatment, which he said helps satisfy the integrated safety summary (ISS) expectations.
On efficacy, Tassé said VITESSE showed a “placebo-adjusted delta of 32 points” between active and placebo at one year and surpassed the statistical endpoint DBV expected from the agency. He also emphasized that DBV’s studies include open-label extension periods intended to evaluate longer-term benefit, stating that efficacy improves over time and that the side-effect profile “if anything” improves slightly over time.
For the one-to-three-year-old program, Tassé provided comparative figures from DBV’s earlier results. He cited a 67% response rate on active treatment versus 33.5% on placebo and said the lower bound of the confidence interval reflected a 22.4% delta, above a 15% benchmark he said the agency requires. He also described longer-term outcomes in that age group, saying 67% efficacy at year one increased to 86% at year three against the primary endpoint. Tassé highlighted what he characterized as a key disease-modification data point: after three years of treatment, 68% of toddlers could consume the full food challenge (12–14 peanuts’ worth of peanut protein) without an anaphylactic reaction, moving from reactivity at 100 milligrams at entry to more than five grams at exit.
Market size and commercial approach
Tassé estimated that the U.S. has approximately 390,000 children aged four to seven with diagnosed peanut allergy and about 280,000 children aged one to three, for a total of roughly 670,000 children ages one to seven. He also said DBV estimates that about three out of five children with peanut allergy are already seen by an allergist, leaving 40% who would need to be brought into allergy specialty care.
DBV expects the primary prescriber base to be allergists and immunologists, which Tassé estimated at about 4,500 in the U.S. He said the company believes it can reach those prescribers with approximately 50 to 70 sales representatives, though he noted the company is finalizing that assessment. Tassé also said outreach to families will be important, describing parents of food-allergic children and advocacy groups as engaged and well organized.
On pricing, Tassé said DBV has not finalized a price. As a “helpful analog,” he referenced Palforzia—an oral immunotherapy (OIT) product—as having a net price of about $1,000 per month. He said DBV has had qualitative discussions with investors and payers and that this serves as a reference point for modeling, with a possible premium, though he emphasized that DBV has not completed quantitative research to set pricing.
Competitive context: IgE blockade and Palforzia
Asked about competition from IgE blockade, Tassé argued it is not a major patient-level competitor for DBV’s targeted population. He said allergists generally do not want to use chronic systemic IgE blockade in a developing immune system unless a child has multiple allergies plus conditions such as atopic dermatitis. He also cited the practical issue of injections as a deterrent for some families.
Discussing Palforzia, Tassé said the product was important as the first FDA-approved desensitization therapy for food allergy, but he described challenges with OIT dosing escalation. He said escalation requires physician office visits every two weeks, totaling roughly 11 to 16 visits over six to nine months, and cited anaphylaxis rates of 18% during escalation and 15% during maintenance. He also described activity limitations tied to Palforzia risk mitigation, including a requirement that children remain at rest for three hours after dosing.
By contrast, Tassé said Viaskin Peanut in DBV’s studies required only the first patch to be administered in the doctor’s office with a one-hour observation period used for training families on use. He said there were no severe anaphylaxis cases in DBV’s clinical studies and that study participants had no limitations on daily living activities. He said DBV would still recommend carrying an epinephrine auto-injector as a precaution, including because many children have additional allergies.
Manufacturing, pipeline priorities, and cash runway
Tassé said DBV’s product is manufactured through a contract manufacturing organization (CMO) in France and that the company can supply the initial years of a launch. He said DBV would likely need to triple manufacturing capacity over the next few years to support later demand and potential expansion outside the U.S., noting that building and qualifying manufacturing capacity can take about three years. He added that DBV would need “a handful of weeks” after approval to launch, primarily to package product with the brand name and necessary codes.
On pipeline priorities, Tassé said the company is “Phase IIb ready” for cow’s milk allergy as a second product and has a pre-IND program in celiac disease, but emphasized that DBV’s focus is on getting Viaskin Peanut approved to validate the platform and support future indications.
Finally, Tassé discussed liquidity, stating the company had $320 million on a pro forma Q3 basis and said it is “sufficiently funded” to take the company through a 2027 launch, including investments needed to build inventory and establish what he characterized as a significant brand.
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.
