DBV Technologies (DBVT) said Monday the US Food and Drug Administration has agreed with the company's proposal that the safety exposure data from the its phase 3 study for Viaskin peanut patch in four- to seven-year-olds will be enough to support a biologics license application filing in this age group.
The company plans to submit the application for the food allergies patch in H1 2026, potentially accelerating the product launch by about one year.
DBV said it had cash and cash equivalents of $32.5 million as of the end of 2024, likely not enough to support its operating plan for the next 12 months. As such, it said there's "substantial doubt" about its ability to continue as a going concern.
The company said it is actively reviewing potential financing and strategic options with its financial advisers.
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