What happened
Shares of DBV Technologies(NASDAQ: DBVT) were soaring 19% higher as of 11:33 a.m. ET on Friday. The big gain came after the company announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold on a late-stage clinical study evaluating Viaskin Peanut 250 microgram patch (DBV712) in children between the ages of four and seven with peanut allergies.
So what
The FDA placed DBV Technologies' phase 3 study of DBV712 on partial clinical hold in September 2022. At the time, the agency specified four changes to the clinical trial's design that were needed to support a potential future regulatory submission:
- A redefinition of the minimal daily wear time for the DBV712 patch
- The addition of a new test to assess the patch's adhesion
- The reclassification of some adverse events to highlight them as adverse events of special interest
- An increase in the number of participants on active treatment in the late-stage study
DBV made all of the required changes to the FDA's satisfaction and will also conduct a separate safety study. The agency will now allow the company's late-stage study of DBV712 to move forward.
This was a much-needed win for DBV. The biotech stock is down more than 50% from its high set earlier this year. DBV712 is the company's lead pipeline candidate, DBV doesn't have any products on the market yet.
Now what
DBV now plans to begin screening patients for its late-stage study of DBV712 in the first quarter of 2023. This process is expected to continue into the first half of 2024. Results from the study should be announced in the first half of 2025.
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Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
