DBV Technologies (NASDAQ:DBVT) stock is soaring higher on Friday after providing an update on its peanut allergy treatment.
DBV Technologies is working on a product called Viaskin Peanut to treat peanut allergies in children between the ages of four and 11 years old. The company says that its communications with the U.S. Food and Drug Administration (FDA) so far have been positive.
According to a news release from DBV Technologies, its working alongside the FDA to alter the patch. It plans to do so and conduct a clinical trial determining the effectiveness of the new patch and other changes.
The company makes sure to note that these changes won’t result in the FDA viewing the updated patch as a new drug. That gives the company a clear path forward for regulatory approval of Viaskin Peanut.
Daniel Tassé, CEO of DBV Technologies, said this about the news boosting DBVT stock higher today.
“I want to thank the DBV team for their dedication in working to address the FDA’s findings over the past few months. We intend to advance a remediation plan for Viaskin™ Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin™ Peanut, if approved, to patients suffering from peanut allergies.”
DBV Technologies plans to selected updated patches in Q1 2021. It will then seek FDA comments in Q2 2021 before starting its next clinical trial.
DBVT stock was up 42.1% as of Friday morning.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.