Sanofi discontinued clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis after determining the data did not support a meaningful improvement over standard of care. The decision comes as part of a strategic pipeline assessment under new leadership. Sanofi shares fell 1.2% to 75.46 euros on the Euronext Paris exchange.
Sanofi shares fell 1.2% after the company discontinued amlitelimab in atopic dermatitis, deciding not to submit the OX40-ligand blocker for global regulatory reviews.
"The totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD," Sanofi said in a statement Thursday. The ESTUARY phase 3 long-term extension study showed sustained clinical response without relapse in patients aged 12 and older, but the drug failed to differentiate from the standard of care.
Sanofi fell to 75.46 euros in Paris trading, bringing its year-to-date decline to 8.6%. The French drugmaker is not amending its full-year 2026 guidance as a result of the decision. Additional results from the amlitelimab program in atopic dermatitis, including from the ESTUARY study, will be presented at a forthcoming medical meeting.
The decision removes a potential competitor to Regeneron Pharmaceuticals Inc.'s Dupixent, which generated about 14 billion euros in sales last year for atopic dermatitis and related conditions. Amlitelimab, a fully human monoclonal antibody that blocks OX40L signaling to normalize T-cell-mediated inflammation without depleting T cells, was considered a promising candidate in Sanofi's immunology pipeline. The company will work with investigators and regulatory authorities to wind down ongoing amlitelimab AD studies and transition enrolled patients to appropriate care.
Sanofi's phase 2 study of amlitelimab in celiac disease remains ongoing, with data expected in the second half of 2026. The discontinuation shows management is prioritizing pipeline assets with clearer differentiation, a shift investors will watch as the company prepares to report second-quarter earnings on July 29. Analysts had projected peak sales for amlitelimab in atopic dermatitis at several billion euros, though Sanofi did not disclose its internal estimates.
This article is for informational purposes only and does not constitute investment advice.
