(News Bulletin 247) – DBV Technologies progressed this Thursday on the Paris Stock Exchange after receiving precise answers from the FDA, the American health authority, with a view to an upcoming marketing application for Viaskin Peanut in children .
Around 10:45 a.m., the title gained 4.4% after jumping 10% at the opening, which allows it to only show a decline of around 5% since the start of the year.
In a statement last night, DBV says the FDA has confirmed that its ‘Epitope’ Phase 3 study met pre-specified success criteria for the primary endpoint, without the need for an additional efficacy study.
Additional data will however be necessary to supplement those collected during the study and support a request for a biological product license (BLA), specifies the biotech.
This additional safety study in children 1-3 years old using the original Viaskin Peanut patch aims to augment the data collected in the ‘Epitope’ study.
As of March 31, DBV’s cash and cash equivalents were $192.3 million, compared to $209.2 million as of December 31, 2022.
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