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DBV Technologies: share price falls as Xolair receives green light in the USA

( - DBV Technologies' share price fell by almost 2% on the Paris Bourse on Monday, in the wake of the green light given by the U.
S. Food and Drug Administration (FDA) to the marketing of Xolair, Roche's treatment for food allergies.

On Friday, Roche announced that the FDA had given the go-ahead for Xolair to be marketed in the United States for children and adults suffering from food allergies following accidental exposure.

This green light comes as the results of a phase III study showed that Xolair significantly increased the amount of peanut, milk, egg and cashew needed to trigger an allergic reaction.

In the USA, 17 million people have confirmed food allergies, and more than 40% of children and more than 50% of adults suffering from allergies have had a severe reaction at least once in their lives.

'DBV, which was the best positioned player in this field, has been doubled', lamented the analysts at Invest Securities this morning, pointing out that the French company has been forced to relaunch a new Phase III study to meet the recommendations of the FDA and EMA.

As this trial only started at the beginning of 2022, results are not expected before 2025, which implies a market launch in 2026 at the earliest, adds the brokerage firm.

Invest Securities also points out that the patches developed by DBV only address a single food allergy, unlike Xolair, which limits the allergic reaction.

Analysts also point out that DBV's financial resources are inferior to those of Roche, which, unlike DBV, can rely on an already well-established sales network.

However, should DBV's patch be approved, it could turn out to be less costly to produce and therefore less expensive to sell, continues Invest.

'It could also benefit from another advantage in terms of mode of administration, especially in young children, since the patch is applied once a day to the subject's back as opposed to an injection by syringe in the case of Xolair', concludes the Paris-based firm.

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