Galderma was hit by another U.S. Food and Drug Administration rejection for its Relfydess product and a U.S. launch this year no longer seems likely, Vontobel's Stefan Schneider says in a research note. The exact timing of the potential launch remains unknown as the Swiss skincare specialist awaits feedback from the FDA on a site visit, the analyst says. This is the second time Galderma is unsuccessful in an application for Relfydess, which was already declined by the FDA in 2023, the analyst adds. Vontobel removed U.S. expectations for Relfydess from its Galderma estimates after the first rejection, so the company's investment case remains intact, he says.(adria.calatayud@wsj.com)
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Galderma's U.S. Launch for Relfydess Likely to Be Delayed Beyond 2026 — Market Talk
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Galderma was hit by another U.S. Food and Drug Administration rejection for its Relfydess product and a U.S. launch this year no longer seems likely, Vontobel's Stefan Schneider says in a research note. The exact timing of the potential launch remains unknown as the Swiss skincare specialist awaits…