Galderma Group N

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 has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its Biologics License Application for RelabotulinumtoxinA, with comments related to observations during a manufacturing site inspection and analytical method optimization. All other aspects of the application, including safety and efficacy, did not solicit deficiencies. The company is implementing corrective and preventive actions and plans to respond rapidly, while noting the observations do not impact approvals or launches in other markets. Relfydess, the brand name for relabotulinumtoxinA, is already approved in 33 markets and launched in more than 20, including across Europe, the Middle East, and Australia, with an encouraging early launch trajectory. Regulatory filings in other territories remain on track.