Sanofi scrapped its amlitelimab filing in atopic dermatitis after the data did not show a meaningful improvement over existing therapies. The AlphaScala Score for SNY is 52.
Sanofi scrapped its amlitelimab program in moderate-to-severe atopic dermatitis Monday. The company said the phase 3 data package did not support a global regulatory filing.
The ESTUARY long-term extension study showed patients aged 12 and older maintained clinical response. Sanofi said the safety profile was consistent with earlier data. The drug would not represent "a meaningful improvement to the standard of care" for AD patients.
Amlitelimab is a fully human monoclonal antibody that blocks the OX40L pathway, a key immune regulator. Sanofi had positioned it as a potential successor asset in its immunology franchise, which leans heavily on Dupixent. The AD market has several effective options. Eli Lilly's Ebglyss and AbbVie's Rinvoq have raised the bar for new entrants.
Sanofi did not amend its full-year 2026 guidance because of the decision.
The drug is not dead entirely. A phase 2 study in celiac disease is still running. Sanofi expects a readout in the second half of 2026. Celiac disease has no approved drug therapies.
SNY carries an Alpha Score of 52 on AlphaScala, in the Mixed zone. The score reflects the pipeline uncertainty and the pressure on Dupixent from biosimilar competition. Read more on the SNY stock page.
Sanofi is not the only biotech betting on novel immune mechanisms. Teva recently advanced an anti-IL-15 antibody into phase 2b after a vitiligo trial readout.
The celiac disease data, due in the second half of 2026, is the next major readout on the asset's future.
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