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SNY & REGN's Dupixent Gets EU Nod for Chronic Spontaneous Urticaria
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Key Takeaways
The EU approved Dupixent for moderate-to-severe chronic spontaneous urticaria in patients 12 and older.
Study A and C showed Dupixent reduced itch and hives and improved disease control versus placebo at 24 weeks.
Safety findings from all LIBERTY-CUPID studies aligned with the known safety profile of Dupixent.
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (“CSU”) in adults and adolescents.
The targeted population for this approval includes patients aged 12 years and above with moderate-to-severe disease who have an inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti-immunoglobulin E (IgE) therapy.
Following the latest nod, Dupixent became the first targeted medicine to be approved for CSU in the European Union in over a decade. The drug is now approved for seven types of chronic, inflammatory diseases in the European Union.
CSU is an inflammatory skin condition, primarily caused by type II inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment.
SNY’s Price Performance
Year to date, Sanofi’s shares have gained 1.9% compared with the industry’s 16% growth.
Image Source: Zacks Investment Research
Dupixent was approved in the United States for the CSU indication in April 2025. The FDA’s approval of Dupixent for CSU marked its seventh indication, followed by another U.S. approval in June 2025 for bullous pemphigoid, reflecting the eighth indication.
Dupixent is also approved for the CSU indication in Japan.
The drug is currently approved for eight type II inflammatory diseases in the United States, including severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
More on the Latest EU Nod for SNY/REGN's Dupixent in CSU
The European Union nod for Dupixent for the CSU indication is based on data from two late-stage studies, Study A and Study C, in the phase III LIBERTY-CUPID program, which evaluated it as an add-on therapy to standard-of-care antihistamines compared with antihistamines alone in the given patient population.
Data from the studies showed that treatment with Dupixent significantly reduced itch and hives (urticaria activity) versus placebo at 24 weeks. Treatment with Dupixent also increased the percentage of patients with well-controlled disease and complete response versus placebo at 24 weeks.
Another study in the LIBERTY-CUPID program, Study B, conducted in a different CSU patient population, provided additional safety data on treatment with Dupixent.
Importantly, safety data from Study A, Study B and Study C were similar to the known safety profile of Dupixent in its approved indications.
In September, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending the approval of Dupixent in the European Union for treating CSU.
Dupixent — Key Top-Line Driver for SNY & REGN
Dupixent is jointly marketed by Sanofi and Regeneron under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits or losses in connection with the global sales of the drug.
In the first nine months of 2025, Dupixent generated global product sales of €11.47 billion, which were recorded by Sanofi, representing growth of 22.7% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.
Regeneron recorded collaboration revenues of $4.24 billion from Sanofi during the first nine months of 2025, up 27.8% year over year.
SNY/REGN’s supplemental biologics license application seeking approval for Dupixent for treating adults and children aged six years and older with allergic fungal rhinosinusitis ("AFRS") is currently under priority review in the United States. A decision from the FDA is expected by Feb. 28, 2026.
If approved, it would be the first medicine specifically indicated for AFRS and Dupixent’s ninth U.S. approval.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share have increased from $1.24 to $2.87. Earnings per share estimates for 2026 have moved up from $2.09 to $2.88 during the same period. CRMD stock has surged 21.2% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from 65 cents to 23 cents. Loss per share estimates for 2026 have narrowed from $2.10 to $1.42 during the same period. CSTL stock has risen 44.5% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with an average surprise of 66.11%.
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SNY & REGN's Dupixent Gets EU Nod for Chronic Spontaneous Urticaria
Key Takeaways
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (“CSU”) in adults and adolescents.
The targeted population for this approval includes patients aged 12 years and above with moderate-to-severe disease who have an inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti-immunoglobulin E (IgE) therapy.
Following the latest nod, Dupixent became the first targeted medicine to be approved for CSU in the European Union in over a decade. The drug is now approved for seven types of chronic, inflammatory diseases in the European Union.
CSU is an inflammatory skin condition, primarily caused by type II inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment.
SNY’s Price Performance
Year to date, Sanofi’s shares have gained 1.9% compared with the industry’s 16% growth.
Image Source: Zacks Investment Research
Dupixent was approved in the United States for the CSU indication in April 2025. The FDA’s approval of Dupixent for CSU marked its seventh indication, followed by another U.S. approval in June 2025 for bullous pemphigoid, reflecting the eighth indication.
Dupixent is also approved for the CSU indication in Japan.
The drug is currently approved for eight type II inflammatory diseases in the United States, including severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
More on the Latest EU Nod for SNY/REGN's Dupixent in CSU
The European Union nod for Dupixent for the CSU indication is based on data from two late-stage studies, Study A and Study C, in the phase III LIBERTY-CUPID program, which evaluated it as an add-on therapy to standard-of-care antihistamines compared with antihistamines alone in the given patient population.
Data from the studies showed that treatment with Dupixent significantly reduced itch and hives (urticaria activity) versus placebo at 24 weeks. Treatment with Dupixent also increased the percentage of patients with well-controlled disease and complete response versus placebo at 24 weeks.
Another study in the LIBERTY-CUPID program, Study B, conducted in a different CSU patient population, provided additional safety data on treatment with Dupixent.
Importantly, safety data from Study A, Study B and Study C were similar to the known safety profile of Dupixent in its approved indications.
In September, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending the approval of Dupixent in the European Union for treating CSU.
Dupixent — Key Top-Line Driver for SNY & REGN
Dupixent is jointly marketed by Sanofi and Regeneron under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits or losses in connection with the global sales of the drug.
In the first nine months of 2025, Dupixent generated global product sales of €11.47 billion, which were recorded by Sanofi, representing growth of 22.7% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.
Regeneron recorded collaboration revenues of $4.24 billion from Sanofi during the first nine months of 2025, up 27.8% year over year.
SNY/REGN’s supplemental biologics license application seeking approval for Dupixent for treating adults and children aged six years and older with allergic fungal rhinosinusitis ("AFRS") is currently under priority review in the United States. A decision from the FDA is expected by Feb. 28, 2026.
If approved, it would be the first medicine specifically indicated for AFRS and Dupixent’s ninth U.S. approval.
SNY's Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share have increased from $1.24 to $2.87. Earnings per share estimates for 2026 have moved up from $2.09 to $2.88 during the same period. CRMD stock has surged 21.2% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from 65 cents to 23 cents. Loss per share estimates for 2026 have narrowed from $2.10 to $1.42 during the same period. CSTL stock has risen 44.5% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with an average surprise of 66.11%.