RAD 2025: Long-Term Data on Nemluvio ® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to

Galderma announced two-year data from a long-term extension study of Nemluvio in moderate-to-severe atopic dermatitis, demonstrating sustained improvements in itch and skin lesions with prolonged treatment and no new safety signals; more than 85% of patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI) at week 104, reinforcing Nemluvio's potential as a long-term treatment option. These findings, presented at the Revolutionizing Atopic Dermatitis (RAD) Conference, build upon previous Phase III data and support Nemluvio's efficacy and safety profile, potentially bolstering its market position given its recent approvals for both atopic dermatitis and prurigo nodularis.

Analysis

Galderma (SIX: GALD) has presented compelling new interim two-year data from a long-term extension study of Nemluvio for moderate-to-severe atopic dermatitis, reinforcing its strong efficacy and safety profile. The findings, showcased at the Revolutionizing Atopic Dermatitis (RAD) Conference, demonstrate sustained and increased improvements in key patient outcomes: at week 104, over 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), approximately 85% reported at least a four-point improvement in itch (SCORAD VAS Pruritus), with 70% achieving itch-free or nearly itch-free status, and around 60% reached clearance or near-clearance of skin lesions (IGA score). Importantly, no new safety signals were identified during the prolonged treatment up to two years, building on the consistent safety profile observed in the phase III ARCADIA program. The data also highlighted Nemluvio's rapid onset, with 49% of treatment-naïve patients achieving EASI-75 and 69% achieving a four-point itch improvement by week 4. These results are significant as Nemluvio, the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, recently received FDA approvals for both atopic dermatitis (December 2024) and prurigo nodularis (August 2024), positioning it uniquely with flexible dosing schedules, including a potential eight-week interval for appropriate atopic dermatitis patients. The positive long-term data is pivotal for expanding Nemluvio's evidence base, supporting its ongoing global launches and potentially enhancing its competitive standing in the substantial atopic dermatitis market, which affects over 230 million people worldwide. Further data on prurigo nodularis from the OLYMPIA study will also be presented, adding to the drug's comprehensive clinical profile.

Key Decisions for Investors

• The compelling two-year Nemluvio data enhances Galderma's (GALD) growth prospects; investors should assess the potential for increased market share and revenue contribution from this differentiated therapeutic.
• Investors should closely monitor Nemluvio's commercial launch trajectory and sales figures, particularly in key markets like the U.S., as these will be critical indicators of market acceptance and financial impact.
• Consider the strengthened competitive profile of Nemluvio against existing and emerging treatments for atopic dermatitis and prurigo nodularis when evaluating GALD's long-term value proposition, especially given its unique mechanism and dosing flexibility.