Viaskin Peanut - (VITESSE)

June 29, 2026: DBV Technologies (Euronext Paris: DBV; Nasdaq: DBVT) provided an update on its planned Biologics License Application (BLA) submission seeking U.S. marketing approval of the VIASKIN® Peanut Patch for peanut-allergic children aged 4–7 years. The company said it has had extensive, detailed, iterative engagement with the FDA via meetings, information exchanges, and filings under the product’s IND to help ensure a complete and efficient review once the BLA is submitted. DBV reported that the FDA provided actionable feedback focused on organization, mapping, and formatting of existing datasets for CMC and biostatistics portions of the BLA, and that the agency has not requested additional data. Based on the time needed to incorporate this feedback, DBV now anticipates submitting the BLA in 3Q 2026. DBV management planned an investor conference call/webcast on June 29, 2026 at 5:00pm ET to discuss the update.