Galderma Group AG fell nearly 6% on Wednesday after the U.S. Food and Drug Administration declined to approve its wrinkle treatment RelabotulinumtoxinA, delaying the product's planned entry into the U.S. aesthetics market. The stock dropped 5.8% to CHF 173.25, sharply underperforming the benchmark SMI which traded little changed in afternoon dealings. The FDA issued a Complete Response Letter, citing manufacturing-related observations identified during inspections, marking the second time the regulator has declined the application after a similar manufacturing-related setback in 2023, though no new concerns were raised over safety or efficacy. Galderma said it is working to address the FDA's observations and plans to engage with the regulator on next steps as quickly as possible, reiterating that securing U.S. approval remains an important strategic objective. The decision is limited to the U.S. submission and will not affect existing approvals or ongoing reviews in other markets, where the treatment, marketed as Relfydess, is already available in more than 20 countries including Europe, the United Kingdom, Australia and parts of Asia.
Galderma Group NFDA issued Complete Response Letter declining approval of RelabotulinumtoxinA due to manufacturing issues, delaying U.S. market entry.