Galderma Group AG shares slid sharply on Wednesday after the U.S. Food and Drug Administration declined to approve the companys wrinkle treatment RelabotulinumtoxinA, reversing the products planned entry into the U.S. aesthetics market for the time being.
The stock closed down 5.8% at CHF 173.25, underperforming Switzerlands SMI index which was largely unchanged in afternoon trading.
Regulatory decision
The FDA issued a Complete Response Letter, pointing to manufacturing-related observations identified during inspections carried out as part of its review. This represents the second time the regulator has declined the application on manufacturing grounds following a similar issue in 2023. The agency did not raise new concerns related to the products safety or efficacy.
Company response
Galderma said it is addressing the FDAs observations through corrective and preventive actions and intends to engage with the regulator about next steps as promptly as possible. The company reiterated that obtaining U.S. approval for RelabotulinumtoxinA remains an important strategic priority.
Management emphasized that the FDAs decision pertains only to the U.S. submission and will not affect existing approvals, commercial launches, or ongoing regulatory reviews in other jurisdictions. The treatment is marketed under the name Relfydess and is currently available in more than 20 countries, including across Europe, the United Kingdom, Australia and parts of Asia.
Strategic context
The delay comes as Galderma seeks to expand its footprint in the global aesthetics market, where botulinum toxin products compete with established brands such as AbbVies Botox. The company had been preparing RelabotulinumtoxinA for a U.S. entry that would position it against those incumbents.
Market reaction and outlook
Investors reacted to the regulatory setback with a near 6% sell-off in the stock. Galderma has signaled it will pursue corrective measures and discussions with the FDA, but the timeline for resubmission or resolution of the manufacturing observations was not provided.