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SNY Down Despite Eczema Candidate Meeting Goal in Phase III Study
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Key Takeaways
Sanofi reported amlitelimab met all primary and key secondary endpoints in the COAST 1 study.
Treatment showed significant skin clearance and disease severity improvement versus placebo.
Amlitelimab could stand out as the only atopic dermatitis therapy with dosing just four times yearly.
Sanofi (SNY - Free Report) announced positive data from the phase III COAST 1 study, which evaluated the safety and efficacy of its anti-OX40L mAb, amlitelimab, for treating moderate-to-severe atopic dermatitis (also known as eczema) in patients aged 12 years and above.
The study met all primary and key secondary endpoints.
Data from the COAST 1 study showed that treatment with amlitelimab dosed either every four weeks or every 12 weeks led to a statistically significant and clinically meaningful efficacy in skin clearance and disease severity versus placebo at week 24 in the given patient population.
Treatment with amlitelimab was generally safe and well-tolerated, with no new safety concerns observed.
Despite the positive data, shares of Sanofi were down 8.8% in pre-market trading on Sept. 4 as the data fell short of investors' expectations.
A Bloomberg article mentioned that some analysts felt that amlitelimab was less effective than Sanofi and partner Regeneron’s (REGN - Free Report) blockbuster drug Dupixent, which is approved for several types of inflammatory diseases, including moderate-to-severe atopic dermatitis.
In the first half of 2025, Dupixent recorded sales worth €7.31 billion, reflecting an increase of 20.7% year over year. The drug holds the number one new-to-brand prescription market share across all its approved indications in the United States. SNY and REGN are working to expand the drug’s label further.
While Sanofi records global net product sales of Dupixent, Regeneron records its share of profit in connection with the global sales of the drug.
SNY’s Stock Performance
Year to date, shares of Sanofi have increased 3.5% against the industry’s decline of 0.1%.
Image Source: Zacks Investment Research
More on SNY’s Study on Amlitelimab
Per management, the COAST 1 study meeting the primary and secondary endpoints underlines the potential of amlitelimab as the first and only atopic dermatitis therapy with possible dosing of only four times per year, which can differentiate the candidate from existing therapies for treating eczema.
Amlitelimab is currently being evaluated in the OCEANA clinical development program, which includes the COAST 1 study as well as four other phase III studies (SHORE, COAST 2, AQUA, and ESTUARY). Data from these other studies are expected through 2026, and if positive, might support the global regulatory filings for amlitelimab for atopic dermatitis.
Investors will now wait for additional phase III data, which is likely to offer a comprehensive understanding of amlitelimab’s long-term efficacy and safety profile.
Besides atopic dermatitis, Sanofi is also developing amlitelimab in mid-stage studies for treating celiac disease, alopecia areata, asthma and systemic sclerosis.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.85. Loss per share estimates for 2026 have narrowed from $4.27 to $4.14 during the same period. AKRO stock has surged 64% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 114.3% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
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SNY Down Despite Eczema Candidate Meeting Goal in Phase III Study
Key Takeaways
Sanofi (SNY - Free Report) announced positive data from the phase III COAST 1 study, which evaluated the safety and efficacy of its anti-OX40L mAb, amlitelimab, for treating moderate-to-severe atopic dermatitis (also known as eczema) in patients aged 12 years and above.
The study met all primary and key secondary endpoints.
Data from the COAST 1 study showed that treatment with amlitelimab dosed either every four weeks or every 12 weeks led to a statistically significant and clinically meaningful efficacy in skin clearance and disease severity versus placebo at week 24 in the given patient population.
Treatment with amlitelimab was generally safe and well-tolerated, with no new safety concerns observed.
Despite the positive data, shares of Sanofi were down 8.8% in pre-market trading on Sept. 4 as the data fell short of investors' expectations.
A Bloomberg article mentioned that some analysts felt that amlitelimab was less effective than Sanofi and partner Regeneron’s (REGN - Free Report) blockbuster drug Dupixent, which is approved for several types of inflammatory diseases, including moderate-to-severe atopic dermatitis.
In the first half of 2025, Dupixent recorded sales worth €7.31 billion, reflecting an increase of 20.7% year over year. The drug holds the number one new-to-brand prescription market share across all its approved indications in the United States. SNY and REGN are working to expand the drug’s label further.
While Sanofi records global net product sales of Dupixent, Regeneron records its share of profit in connection with the global sales of the drug.
SNY’s Stock Performance
Year to date, shares of Sanofi have increased 3.5% against the industry’s decline of 0.1%.
Image Source: Zacks Investment Research
More on SNY’s Study on Amlitelimab
Per management, the COAST 1 study meeting the primary and secondary endpoints underlines the potential of amlitelimab as the first and only atopic dermatitis therapy with possible dosing of only four times per year, which can differentiate the candidate from existing therapies for treating eczema.
Amlitelimab is currently being evaluated in the OCEANA clinical development program, which includes the COAST 1 study as well as four other phase III studies (SHORE, COAST 2, AQUA, and ESTUARY). Data from these other studies are expected through 2026, and if positive, might support the global regulatory filings for amlitelimab for atopic dermatitis.
Investors will now wait for additional phase III data, which is likely to offer a comprehensive understanding of amlitelimab’s long-term efficacy and safety profile.
Besides atopic dermatitis, Sanofi is also developing amlitelimab in mid-stage studies for treating celiac disease, alopecia areata, asthma and systemic sclerosis.
SNY's Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.85. Loss per share estimates for 2026 have narrowed from $4.27 to $4.14 during the same period. AKRO stock has surged 64% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 114.3% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.