DBV Technologies menunda pengajuan BLA VIASKIN Peanut Patch ke Q3 2026

DBV kini akan mengajukan BLA untuk VIASKIN Peanut Patch pada anak usia 4-7 tahun di Q3 2026, bukan sesuai jadwal sebelumnya. Penundaan ini terjadi setelah dialog pra-pengajuan yang ekstensif dengan FDA untuk mengoptimalkan organisasi data CMC dan biostatistik. FDA tidak meminta data klinis tambahan.

Fakta utama

Diajukan: 29 Jun 2026, 20.28
Peristiwa: Permohonan diajukan
Arah: Netral
Perusahaan: DBVTDBV Technologies
Aset: VIASKIN Peanut Patch
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 d108693dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Châtillon, France, June 29, 2026 DBV Technologies Provides BLA Submission Update for the VIASKIN ® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing • DBV has been engaged in extensive discussions with the FDA in preparation of its BLA for the VIASKIN ® Peanut Patch in children aged four through seven years • The objective of the detailed, iterative engagement was to ensure a complete, efficient, and timely FDA review of the BLA, once submitted • The Agency has not requested additional data • DBV will take additional time to incorporate the FDA feedback and anticipates submitting the BLA in the third quarter of 2026 • DBV will host a co

SEC 8-K