Sanofi SA (NASDAQ:SNY) on Friday announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis (AD).
Amlitelimab was considered a potential successor to the blockbuster eczema drug Sanofi and Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Dupixent.
Two additional phase 3 studies, AQUA and ESTUARY, were anticipated to report results in the second half of 2026. Global regulatory submissions were planned for the second half of 2026.
Long-Term Study Shows Durable Response But Limited Clinical Advantage
The decision not to submit for global regulatory reviews was made as part of an ongoing strategic assessment of the pipeline.
Sanofi has determined that the totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD.
Sanofi said that while the ESTUARY phase 3 long-term extension study showed long-term maintenance of clinical response without relapse, amlitelimab would not represent a meaningful improvement to the standard of care for patients with AD.
Additional results from the amlitelimab development program in AD, including from the ESTUARY study, will be presented at a forthcoming medical meeting.
Prior Trial Results Raised Questions
In September 2025, Sanofi stock tumbled after late-stage trial results for amlitelimab failed to match investor expectations, raising fresh doubts about the company’s ability to sustain its dermatology franchise once patent protections expire.
SNY Stock Price Activity: Sanofi shares were down 0.23% at $43.14 during premarket trading on Friday, according to Benzinga Pro data.
Photo by HJBC via Shutterstock
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