DBV Technologies inaantala ang VIASKIN Peanut Patch BLA hanggang Q3 2026

DBV ay maghahain na ngayon ng BLA nito para sa VIASKIN Peanut Patch sa mga batang 4-7 taong gulang sa Q3 2026 sa halip na mas maagang timeline. Ang pagkaantala ay kasunod ng malawak na pre-submission dialogue sa FDA upang i-optimize ang CMC at biostatistical data organization. Ang FDA ay hindi humiling ng anumang karagdagang clinical data.

Mahahalagang fact

Na-file: Hun 29, 2026, 08:28 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: DBVTDBV Technologies
Asset: VIASKIN Peanut Patch
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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