DBV Technologies: Nakaplanong pagsumite ng BLA para sa VIASKIN Peanut Patch (4-7 taong gulang) sa H1 2026

Ang 8-K ay nagsasaad na ang Phase 3 VITESSE topline results ay positibo at ngayon ay inaasahan ng kumpanya na magsumite ng BLA para sa VIASKIN Peanut Patch sa mga batang may peanut allergy na may edad 4-7 taong gulang sa unang kalahati ng 2026, na may potensyal para sa Priority Review. Ang pangalawang pagsumite ng BLA para sa mga sanggol na may edad 1-3 taong gulang ay nakaplanong sa ikalawang kalahati ng 2026 sa ilalim ng Accelerated Approval Pathway. Ang mga nakaplanong pagsumite na ito ay kumakatawan sa susunod na konkretong regulatory milestones para sa asset.

Mahahalagang fact

Na-file: Mar 26, 2026, 09:25 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: DBVTDBV Technologies
Asset: VIASKIN Peanut Patch
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 d113165dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DBV Technologies Reports Full Year 2025 Financial Results and Business Update • Continued advancing the VIASKIN ® Peanut Patch clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old) • Bolstered executive leadership team in preparation for BLA submission and potential approval • Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “ Company ”), a late-stage biopharmaceutical company, today reported financial results for the full

SEC 8-K