DBV Technologies (AO) | Buy | BLA filing delayed to Q3 2026 following FDA interactions

研报英文原文证据摘录

DBV Technologies (AO) | Buy | BLA filing delayed to Q3 2026 following FDA interactions

News comment

Release date: 30 June 2026

Justine Telliez

Equity Research Analyst

+33 1 53 65 35 94

jtelliez@keplercheuvreux.com

BuyDBV Technologies

France | Pharma & biotech Beta Profile: MCap: EUR777.5M

Target Price: EUR5.50 Bloomberg: DBV FP Reuters: DBV.PA

Current Price: EUR2.86 Free float 58%

Up/downside: 92.0% Avg. daily volume (EURm) 4.3

YTD abs performance -15.3% Market data: 29 June 2026

52-week high/low (EUR) 4.26/1.48

BLA filing delayed to Q3 2026 following FDA interactions

Key points:

DBV announced that the BLA submission for VIASKIN Peanut in children aged 4–7 years is now expected in Q3 2026, versus

previous guidance for H1 2026, following recent interactions with the FDA.

Importantly, the FDA has not requested any additional clinical or non-clinical data, with the delay solely reflecting the

incorporation of Agency feedback related to the organisation, mapping and formatting of existing CMC and biostatistical datasets.

Management characterised the discussions as constructive and aimed at facilitating a smoother review process, noting that the

feedback reflects the novelty and complexity of the VIASKIN Peanut BLA rather than any deficiency in the underlying data

package.

While the underlying regulatory package appears unchanged, another revision to the filing timeline is nevertheless likely to weigh

on investor confidence and increase scrutiny over DBV's ability to deliver on its remaining regulatory and commercial milestones.

Delay reflects optimisation of the BLA rather than additional regulatory requirements

Following extensive pre-submission interactions with the FDA, DBV received feedback on the presentation, organisation and