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Galderma Group N

Galderma Group AG is a dermatology company operating worldwide. It offers a science-based portfolio of brands and services across injectable aesthetics, dermatological skincare, and therapeutic dermatology. Its flagship brands include Azzalure, ALLUZIENCE, Dysport, Restylane, Restylane Skinboosters, Sculptra, Cetaphil, ALASTIN, Soolantra, Epiduo, Epiduo Forte, Differin, AKLIEF, Oracea, Metvix, NEMLUVIO, Relfydess, Benzac, and Loceryl. The company was founded in 1981 and is headquartered in Zug, Switzerland.

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Biotech & Genomic Medicine▲

Galderma's Nemluvio Shows Three-Year Sustained Improvement in Atopic Dermatitis

Galderma is presenting new three-year data from the ARCADIA long-term extension study showing that Nemluvio, also known as nemolizumab, is well-tolerated and delivers sustained improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis. The findings will be shared in an oral presentation at the 2026 European Academy of Dermatology and Venereology Congress in Vienna on Thursday, October 1, by ARCADIA investigator Dr. Matthias Augustin. At Week 152, up to 91% of patients achieved at least 75% improvement in eczema severity, up to 75% achieved at least 90% improvement, up to 67% achieved clear or almost clear skin, up to 88% achieved clinically meaningful itch relief and up to 92% reported clinically meaningful improvements in dermatology-related quality of life, with no new safety signals identified. Lead investigator Professor Jonathan Silverberg of George Washington University School of Medicine and Health Sciences said the improvements were not only achieved but sustained over time, while Galderma global program head Christophe Piketty said the data underscore the company's commitment to addressing patients' long-term needs. Additional EADV 2026 presentations include a post-hoc analysis concluding Nemluvio has a favorable cutaneous safety profile over two years in atopic dermatitis and prurigo nodularis, and analyses identifying clinically meaningful sleep-disturbance improvements linked to itch intensity and skin lesion severity. Nemluvio, the first approved monoclonal antibody targeting IL-31 signaling, was initially developed by Chugai Pharmaceutical and is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis in more than 40 countries.
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GALD.SW · Technology · Positive Galderma's Nemluvio shows sustained three-year efficacy and favorable safety in atopic dermatitis, supporting its product profile.
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Galderma wins EU approval for Restylane Shaype chin filler

Galderma has received European Union approval for Restylane Shaype under the Medical Device Regulation for temporary chin augmentation. The product, powered by NASHA HD technology, is described as the firmest hyaluronic acid injectable gel available in the facial filler market. With this decision, Restylane Shaype is now approved in Europe, Canada, and Brazil, making it the first-and-only HA shaper in those regions, according to Baldo Scassellati Sforzolini, Global Head of R&D at Galderma.
GALD.SW · Regulation · Positive EU approval for Restylane Shaype under Medical Device Regulation enables market entry.
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Galderma falls after FDA issues second setback for Botox rival

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.
GALD.SW · Regulation · Negative FDA issued Complete Response Letter declining approval of RelabotulinumtoxinA due to manufacturing issues, delaying U.S. market entry.
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Galderma receives FDA Complete Response Letter for RelabotulinumtoxinA

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.
GALD.SW · Regulation · Negative FDA Complete Response Letter with manufacturing site inspection observations delays U.S. approval.
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