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SNY & REGN's Dupixent Receives CHMP Backing for Urticaria in EU
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Key Takeaways
{\"0\":\"CHMP recommends EU approval of Dupixent for chronic spontaneous urticaria in patients 12 and above.\",\"1\":\"Phase III studies showed Dupixent reduced itch, hives and improved disease control.\",\"2\":\"Dupixent sales hit EUR 7.3B in H1 2025, with Sanofi projecting about EUR 22B in sales by 2030.\"}
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for treating chronic spontaneous urticaria (CSU) in adults and adolescents.
The intended population for this recommendation includes patients aged 12 years and above with moderate-to-severe disease who have an inadequate response to histamine-1 antihistamines and are naive to anti-immunoglobulin E therapy. A final decision is expected in the coming months.
We remind the investors that Sanofi and Regeneron’s Dupixent received FDA approval for this indication in April 2025. Following the nod in the United States, Dupixent became the first new targeted therapy to be approved for CSU in more than a decade. The drug is currently approved for eight type II inflammatory diseases in the United States.
Dupixent is already approved in several countries, including the United States and the EU, for treating severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
The FDA’s approval of Dupixent for CSU marked its seventh indication, followed by another U.S. approval in June 2025 for bullous pemphigoid, representing its eighth indication.
Year to date, Sanofi’s shares have lost 2.5% compared with the industry’s 0.9% growth.
Image Source: Zacks Investment Research
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.
CHMP Nod for SNY/REGN’s Dupixent Based on Phase III Studies
The positive CHMP opinion for approval of Dupixent in the EU 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.
Both studies met their primary and secondary endpoints, wherein treatment with Dupixent significantly reduced itch and hives versus placebo at 24 weeks. Treatment with Dupixent also increased the likelihood of well-controlled disease or 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. Dupixent is also approved for the CSU indication in Japan.
Dupixent — Key Top-Line Driver for SNY & REGN
Dupixent is being 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 half of 2025, Dupixent generated global product sales of €7.3 billion, which were recorded by Sanofi, representing growth of 20.7% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 59.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 87.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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SNY & REGN's Dupixent Receives CHMP Backing for Urticaria in EU
Key Takeaways
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for treating chronic spontaneous urticaria (CSU) in adults and adolescents.
The intended population for this recommendation includes patients aged 12 years and above with moderate-to-severe disease who have an inadequate response to histamine-1 antihistamines and are naive to anti-immunoglobulin E therapy. A final decision is expected in the coming months.
We remind the investors that Sanofi and Regeneron’s Dupixent received FDA approval for this indication in April 2025. Following the nod in the United States, Dupixent became the first new targeted therapy to be approved for CSU in more than a decade. The drug is currently approved for eight type II inflammatory diseases in the United States.
Dupixent is already approved in several countries, including the United States and the EU, for treating severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
The FDA’s approval of Dupixent for CSU marked its seventh indication, followed by another U.S. approval in June 2025 for bullous pemphigoid, representing its eighth indication.
Year to date, Sanofi’s shares have lost 2.5% compared with the industry’s 0.9% growth.
Image Source: Zacks Investment Research
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.
CHMP Nod for SNY/REGN’s Dupixent Based on Phase III Studies
The positive CHMP opinion for approval of Dupixent in the EU 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.
Both studies met their primary and secondary endpoints, wherein treatment with Dupixent significantly reduced itch and hives versus placebo at 24 weeks. Treatment with Dupixent also increased the likelihood of well-controlled disease or 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. Dupixent is also approved for the CSU indication in Japan.
Dupixent — Key Top-Line Driver for SNY & REGN
Dupixent is being 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 half of 2025, Dupixent generated global product sales of €7.3 billion, which were recorded by Sanofi, representing growth of 20.7% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.
Sanofi Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
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 Kiniksa Pharmaceuticals (KNSA - 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 earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 59.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 87.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.