Why DBV Technologies (DBVT) Shares Are Jumping Today - DBV Technologies (NASDAQ:DBVT)

The FDA has lifted the partial clinical hold on DBV Technologies DBVT VITESSE Phase 3 clinical trial that will evaluate the modified Viaskin Peanut 250 μg patch (DBV712) in peanut-allergic children ages 4 to 7 years.
In the Partial Clinical Hold (PCH) letter, the FDA requested changes to some aspects of the VITESSE protocol, including:
- Redefinition of the minimal daily wear time.
- Addition of a statistical test for the patch adhesion assessment.
- Reclassification of certain adverse events to adverse events of special interest.
- Increase in the number of trial participants on active treatment.
The FDA initiated the hold in September.
In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter.
DBV plans to initiate a separate safety study in approximately 275 additional subjects. The company does not expect the additional safety study to impact its cash runway guidance.
DBV anticipates initiating VITESSE patient screening in the first quarter of 2023, with the last patient screened in 1H 2024 and topline results anticipated in 1H 2025.
Price Action: DBVT shares are up 40.68% at $1.66 during the premarket session on the last check Friday.

DBV Technologies Shares Jumps As FDA Lifts Partial Hold On Pivotal Trial For Peanut Allergy Patch