DBV Technologies S.A. DBVT
DBV Technologies S.A. (Nasdaq: DBVT) is an immunology/inflammation drug developer. Its lead program, Viaskin Peanut, is in Phase 3 for peanut allergy (children aged 4-7 years). Its next catalyst on record is Viaskin Peanut (ages 4-7): FDA determination of BLA sufficiency for substantive review and Priority Review decision (November 2026).
Upcoming catalysts
- November 2026Viaskin Peanut (ages 4-7) — FDA determination of BLA sufficiency for substantive review and Priority Review decision
The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which we anticipate receipt of a PDUFA target action date.
Next further out: Manufacturing readiness — Fareva Amboise Mock Pre-Approval Inspection completion (February 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Viaskin Peanut (ages 4-7) | peanut allergy | biologic-other | Phase 3 |
| Viaskin Peanut (ages 1-3) | peanut allergy | biologic-other | Phase 3 |
| Viaskin Peanut (ages 6-12 months) | peanut allergy | biologic-other | Phase 2 |
| Viaskin Milk | milk allergy | biologic-other | Pre-clinical |
Recent results and decisions
- Sep 30, 2026submitted DBV submitted its BLA to the FDA for VIASKIN Peanut Patch in children aged 4-7 and requested Priority Review (Breakthrough Therapy designation previously granted).
the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN® Peanut Patch in children with peanut allergy aged 4 through 7 years.
Filing - Sep 29, 2026submitted DBV Technologies submitted a BLA to the FDA for the VIASKIN Peanut Patch in children aged 4-7 years with peanut allergy, supported by the successful Phase 3 VITESSE trial.
The Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN® Peanut Patch in children with peanut allergy aged 4 through 7 years.
Filing - Jul 16, 2026started DBV initiated the Phase 2 THRIVE study of VIASKIN Peanut in infants 6-12 months, evaluating ad lib peanut consumption after 3-4 years of treatment.
Initiated the THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in infants aged 6 through 12 months with peanut allergy
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
- Sanofi SNY
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.