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Sanofi Advances Amlitelimab Toward Global Filings After Positive Phase 3 Atopic Dermatitis Data

Tipranks - Sat Jan 24, 9:20AM CST

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Sanofi ( (SNY) ) just unveiled an update.

On January 23, 2026, Sanofi reported new phase 3 data showing that its investigational monoclonal antibody amlitelimab, which targets OX40-ligand without depleting T cells, delivered a strong efficacy and safety profile in patients aged 12 and older with moderate-to-severe atopic dermatitis. In the SHORE phase 3 trial, amlitelimab given every four or twelve weeks alongside topical therapies met all primary and key secondary endpoints at Week 24 across both US and EU statistical frameworks, with efficacy increasing over time and some patients improving as early as Week 2. In the COAST 2 phase 3 monotherapy study, amlitelimab met the primary vIGA-AD 0/1 endpoint for the US estimand and confirmed the potential for dosing every 12 weeks from treatment initiation, although it did not reach statistical significance on co-primary endpoints under the EU estimand, meaning some secondary outcomes are reported with only nominal significance. Across both studies, amlitelimab’s safety profile was comparable to placebo with similar rates of treatment-emergent and serious adverse events, and a separate phase 2 ATLANTIS trial showed continued efficacy improvements through Week 52, reinforcing OX40-ligand as a promising new mechanism in atopic dermatitis; based on the combined evidence, Sanofi plans to advance amlitelimab to global regulatory submissions, potentially strengthening its position in the competitive immunology market if approved.

The most recent analyst rating on (SNY) stock is a Hold with a $57.00 price target. To see the full list of analyst forecasts on Sanofi stock, see the SNY Stock Forecast page.

Spark’s Take on SNY Stock

According to Spark, TipRanks’ AI Analyst, SNY is a Outperform.

Sanofi’s overall stock score reflects its strong earnings performance and attractive valuation, which are the most significant factors. The company’s financial stability and positive earnings call guidance further support the score, despite some technical analysis indicators suggesting a neutral trend.

To see Spark’s full report on SNY stock, click here.

More about Sanofi

Sanofi is a global biopharmaceutical company headquartered in Paris that develops and markets prescription medicines, vaccines and specialty care therapies, with a growing focus on immunology and inflammatory diseases such as atopic dermatitis.

Average Trading Volume: 2,636,889

Technical Sentiment Signal: Sell

Current Market Cap: $111B

Learn more about SNY stock on TipRanks’ Stock Analysis page.

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