Isinumite ng DBV Technologies ang BLA para sa VIASKIN Peanut Patch sa mga batang 4-7 taong gulang, humihiling ng Priority Review

Isinumite ng DBV Technologies ang BLA sa U.S. FDA para sa VIASKIN Peanut Patch sa mga batang edad 4-7 taon noong Setyembre 29, 2026, na sinusuportahan ng Phase 3 VITESSE trial. Hiniling ng kumpanya ang Priority Review; ang desisyon sa pagtanggap ng file ng FDA, kabilang kung igagawad ang Priority Review, ay inaasahan sa Q4 2026. Kasama rin sa BLA ang target na petsa para sa Pre-Approval Inspection.

Mahahalagang fact

Na-file: Okt 28, 2026, 09:24 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: DBVTDBV Technologies
Asset: VIASKIN Peanut Patch
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Petsa ng pagsusumite ng BLA: Setyembre 29, 2026
Pagpapatala sa Phase 3 VITESSE trial: 654

Sipi mula sa source

EX-99.1 2 d137106dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Press Release Châtillon, France, October 28, 2026 DBV Technologies Reports Third Quarter 2026 Financial Results and Business Update • Submitted the Biologics License Application to U.S. FDA for the VIASKIN ® Peanut Patch in children aged 4-7 Years and requested Priority Review • Accelerated Commercial Readiness towards the launch of the VIASKIN ® Peanut Patch in children aged 4-7 years in the US, if approved • Reported cash and cash equivalents of $165.7 million as of September 30, 2026, funding into third quarter of 2027 • DBV will host a conference call today, October 28, at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage specialty biopharmac

SEC 8-K