Why did Sanofi (NASDAQ:SNY) stop developing amlitelimab for atopic dermatitis?

Sanofi (NASDAQ:SNY) stopped the program because it said the combined efficacy and safety evidence did not support further development. The company concluded that amlitelimab would not provide a meaningful improvement over existing atopic dermatitis treatments.

What were Sanofi’s (NASDAQ:SNY) amlitelimab Phase 3 results?

Sanofi (NASDAQ:SNY) said SHORE met its primary and key secondary endpoints, while COAST 2 missed its EU co-primary endpoints. Sanofi initially planned regulatory submissions before reversing that decision after reviewing the complete evidence.

What does Sanofi’s (NASDAQ:SNY) decision mean for ongoing eczema studies?

Sanofi (NASDAQ:SNY) will wind down ongoing amlitelimab atopic dermatitis studies and coordinate patient-care transitions with investigators and regulators. The company plans to present additional ESTUARY and development-program results at a future medical meeting.

How is the amlitelimab decision affecting Sanofi’s (NASDAQ:SNY) financial guidance?

Sanofi (NASDAQ:SNY) said the decision does not change its full-year 2026 financial guidance. The company is scheduled to report its second-quarter results on July 30, 2026.

What is next for Sanofi’s (NASDAQ:SNY) amlitelimab program?

Sanofi (NASDAQ:SNY) is continuing a Phase 2 amlitelimab study in celiac disease. The company expects results from that study during the second half of 2026.

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Sanofi drops amlitelimab after phase 3 review

Written by Brie CarterPublished Jul 24, 2026, 5:15 PM

Sanofi (NASDAQ:SNY) ended amlitelimab’s atopic dermatitis program after reviewing efficacy and safety evidence from its Phase 3 studies.

In January, Sanofi planned submissions after SHORE succeeded, although COAST 2 missed its EU co-primary endpoints.

“The totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD,” Sanofi said.

ESTUARY showed maintained responses in patients aged 12 and older, but Sanofi said the drug would not meaningfully improve current care.

Sanofi maintained its 2026 guidance.

Sanofi acquired amlitelimab through its 2021 Kymab purchase, paying about $1.1 billion upfront plus possible $350 million milestones.

A Phase 2 celiac disease study remains ongoing, with results expected during the second half of 2026.

Sanofi drops amlitelimab after phase 3 review

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