Galderma falls after FDA issues second setback for Botox rival

Investing.com -- Swiss dermatology companyGalderma Group AG (SIX: GALD) 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 conducted as part of its review. The decision marks the second time the regulator has declined the application after a similar manufacturing-related setback in 2023, although the agency did not raise new concerns over the treatment's safety or efficacy.

Galderma said it is working to address the FDA's observations through corrective and preventive measures and plans to engage with the regulator on the next steps as quickly as possible. The company reiterated that securing U.S. approval for RelabotulinumtoxinA remains an important strategic objective.

The Swiss drugmaker added that the latest regulatory decision is limited to the U.S. submission and will not affect existing approvals, commercial launches or ongoing regulatory reviews in other markets. The treatment, marketed as Relfydess, is already available in more than 20 countries, including across Europe, the United Kingdom, Australia and parts of Asia.

The delay comes as Galderma seeks to expand its presence in the fast-growing global aesthetics market, where botulinum toxin products compete with established brands such as AbbVie's Botox.

Reporting by Roushni Nair

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