By Josh Beckerman

 

DBV Technologies SA shares were recently down 16% to $3.03, following a 29% decline on Wednesday.

The company said Tuesday that the U.S. Food and Drug Administration "requested a stepwise approach" to the development program of its Viaskin Peanut patch for treatment of peanut allergy.

The agency would like to review data from DBV's protein uptake release study prior to providing additional comments on protocol design for the STAMP clinical trial, DBV said. The trial won't begin until DBV receives complete feedback from the FDA, the company said.

A European review is progressing, and DBV is preparing its response to a "Day 180 letter." The company estimates the European Medicines Agency could issue a decision on potential marketing authorization in the first quarter of 2022.

On Tuesday, the company also reported a third-quarter loss of 44 cents a share, compared with a loss of 56 cents a share a year earlier.

 

Write to Josh Beckerman at josh.beckerman@wsj.com

 

(END) Dow Jones Newswires

October 28, 2021 16:04 ET (20:04 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
DBV Technologies (EU:DBV)
Historical Stock Chart
From Nov 2021 to Dec 2021 Click Here for more DBV Technologies Charts.
DBV Technologies (EU:DBV)
Historical Stock Chart
From Dec 2020 to Dec 2021 Click Here for more DBV Technologies Charts.