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SNY & REGN's Dupixent Wins FDA Nod for Pediatric Use in Urticaria
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Key Takeaways
Sanofi and Regeneron secured FDA approval expanding Dupixent use to CSU patients aged 2-11 years.
SNY-backed phase III data showed Dupixent cut itch and hives and improved control at 24 weeks.
Dupixent becomes the first biologic for young CSU patients, with broad approvals across diseases in the U.S.
Sanofi (SNY - Free Report) and its partner Regeneron Pharmaceuticals (REGN - Free Report) announced that the FDA has approved the expanded use of their blockbuster drug, Dupixent, for the treatment of 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 treatment.
Dupixent was previously approved in the United States for the treatment of CSU in adults and adolescents aged 12 years and older in April 2025. With the latest approval, it has become the first biologic medicine for young children with uncontrolled CSU in the region.
Earlier this month, the European Commission also granted approval for CSU patients aged 2 to 11 years in the European Union.
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. It is the fifth disease linked to type II inflammation for which Dupixent is approved in children under 12 years of age.
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.
Year to date, SNY’s shares have declined 3.2% compared with the industry’s 5.5% fall.
Image Source: Zacks Investment Research
FDA Nod to SNY & REGN’s Dupixent Based on Phase III Studies
The FDA 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.
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.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 11.2% 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. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have gained 1.9% 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 Wins FDA Nod for Pediatric Use in Urticaria
Key Takeaways
Sanofi (SNY - Free Report) and its partner Regeneron Pharmaceuticals (REGN - Free Report) announced that the FDA has approved the expanded use of their blockbuster drug, Dupixent, for the treatment of 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 treatment.
Dupixent was previously approved in the United States for the treatment of CSU in adults and adolescents aged 12 years and older in April 2025. With the latest approval, it has become the first biologic medicine for young children with uncontrolled CSU in the region.
Earlier this month, the European Commission also granted approval for CSU patients aged 2 to 11 years in the European Union.
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. It is the fifth disease linked to type II inflammation for which Dupixent is approved in children under 12 years of age.
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.
Year to date, SNY’s shares have declined 3.2% compared with the industry’s 5.5% fall.
Image Source: Zacks Investment Research
FDA Nod to SNY & REGN’s Dupixent Based on Phase III Studies
The FDA 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.
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.
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. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 11.2% 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. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have gained 1.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.