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SNY & REGN's Dupixent Gets EU Approval for Pediatric Use in Urticaria
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Key Takeaways
Sanofi wins EC nod for Dupixent in children aged 2 to 11 years with CSU after inadequate antihistamines.
SNY-backed phase III data showed Dupixent cut itch and hives and improved control at 24 weeks.
Dupixent becomes the first targeted therapy for young CSU children in the EU.
Sanofi (SNY - Free Report) and its partner Regeneron Pharmaceuticals (REGN - Free Report) announced that the European Commission (EC) has approved the expanded use of their blockbuster drug, Dupixent, for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children. This approval supports Dupixent’s use in CSU patients aged 2 to 11 years who have an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy.
The approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion in March 2026, recommending the expanded use of Dupixent.
Dupixent was approved in the European Union for the treatment of CSU in adults and adolescents aged 12 years and older in November 2025. With the latest approval, it has become the first targeted medicine approved for the treatment of young children with CSU in the region.
CSU is an inflammatory skin condition, primarily driven by type II inflammation. This causes sudden and debilitating hives and skin swelling, which is often inadequately controlled by antihistamine treatment.
Year to date, SNY’s shares have lost 3.5% compared with the industry’s 2.2% decline.
Image Source: Zacks Investment Research
EU Nod to SNY & REGN’s Dupixent Based on Phase III Studies
The EC’s approval for Dupixent’s expanded use in children aged 2 to 11 years with CSU is supported by data from two late-stage studies, Study A and Study C, in the phase III LIBERTY-CUPID program and CUPIDKids study.
Data from the studies under the LIBERTY-CUPID program showed that treatment with Dupixent significantly reduced itch and hives (urticaria activity) versus placebo at 24 weeks and increased the percentage of patients with well-controlled disease and a complete response.
In the United States, Dupixent is approved for treating CSU in patients aged 12 and older, but its use in children aged 2 to 11 years remains under FDA review. A supplemental application from SNY/REGN has been accepted, with a final decision expected by April 2026.
Beyond CSU, Dupixent is currently approved in the United States, the European Union, Japan and many other countries for several medical conditions, including asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyposis, chronic obstructive pulmonary disease, eosinophilic esophagitis, prurigo nodularis, bullous pemphigoid and allergic fungal rhinosinusitis across various age groups.
Global Dupixent Growth & Revenue-Sharing Framework
Sanofi has a global strategic collaboration with Regeneron for the discovery, development and commercialization of Dupixent, Kevzara and itepekimab. Per the agreement, Sanofi records global net product sales of Dupixent and Kevzara while Regeneron records its share of profits or losses in connection with the global sales of the drugs. Itepekimab is still in clinical development, with mixed late-stage data and ongoing studies.
Dupixent continues to be a major growth driver, generating $17.8 billion (€15.7 billion) in global sales for Sanofi in 2025, reflecting a 26% year-over-year increase. Meanwhile, Regeneron reported $5.9 billion in collaboration revenues from Sanofi in 2025, primarily driven by Dupixent, representing 30% annual growth.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 6.9% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 14.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
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SNY & REGN's Dupixent Gets EU Approval for Pediatric Use in Urticaria
Key Takeaways
Sanofi (SNY - Free Report) and its partner Regeneron Pharmaceuticals (REGN - Free Report) announced that the European Commission (EC) has approved the expanded use of their blockbuster drug, Dupixent, for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children. This approval supports Dupixent’s use in CSU patients aged 2 to 11 years who have an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy.
The approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion in March 2026, recommending the expanded use of Dupixent.
Dupixent was approved in the European Union for the treatment of CSU in adults and adolescents aged 12 years and older in November 2025. With the latest approval, it has become the first targeted medicine approved for the treatment of young children with CSU in the region.
CSU is an inflammatory skin condition, primarily driven by type II inflammation. This causes sudden and debilitating hives and skin swelling, which is often inadequately controlled by antihistamine treatment.
Year to date, SNY’s shares have lost 3.5% compared with the industry’s 2.2% decline.
Image Source: Zacks Investment Research
EU Nod to SNY & REGN’s Dupixent Based on Phase III Studies
The EC’s approval for Dupixent’s expanded use in children aged 2 to 11 years with CSU is supported by data from two late-stage studies, Study A and Study C, in the phase III LIBERTY-CUPID program and CUPIDKids study.
Data from the studies under the LIBERTY-CUPID program showed that treatment with Dupixent significantly reduced itch and hives (urticaria activity) versus placebo at 24 weeks and increased the percentage of patients with well-controlled disease and a complete response.
In the United States, Dupixent is approved for treating CSU in patients aged 12 and older, but its use in children aged 2 to 11 years remains under FDA review. A supplemental application from SNY/REGN has been accepted, with a final decision expected by April 2026.
Beyond CSU, Dupixent is currently approved in the United States, the European Union, Japan and many other countries for several medical conditions, including asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyposis, chronic obstructive pulmonary disease, eosinophilic esophagitis, prurigo nodularis, bullous pemphigoid and allergic fungal rhinosinusitis across various age groups.
Global Dupixent Growth & Revenue-Sharing Framework
Sanofi has a global strategic collaboration with Regeneron for the discovery, development and commercialization of Dupixent, Kevzara and itepekimab. Per the agreement, Sanofi records global net product sales of Dupixent and Kevzara while Regeneron records its share of profits or losses in connection with the global sales of the drugs. Itepekimab is still in clinical development, with mixed late-stage data and ongoing studies.
Dupixent continues to be a major growth driver, generating $17.8 billion (€15.7 billion) in global sales for Sanofi in 2025, reflecting a 26% year-over-year increase. Meanwhile, Regeneron reported $5.9 billion in collaboration revenues from Sanofi in 2025, primarily driven by Dupixent, representing 30% annual growth.
Sanofi’s Zacks Rank & Stocks to Consider
SNY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 6.9% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 14.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.