REGN & SNY's Dupixent Gets CHMP Nod for Pediatric Use in Urticaria

Regeneron Pharmaceuticals REGN and its partner Sanofi SNY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the expanded use of their blockbuster drug, Dupixent, for treating moderate-to-severe chronic spontaneous urticaria (CSU) in children. The recommendation 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. A final decision of the European Commission is expected in the coming months.

Dupixent was approved in the European Union for the treatment of CSU in adults and adolescents aged 12 years and older in November 2025.

CSU is an inflammatory skin condition, primarily caused by type II inflammation. This causes sudden and debilitating hives and skin swelling, which is often inadequately controlled by antihistamine treatment.

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.

The drug is not yet approved in the United States for CSU in the said patient population. A supplemental biologics license application by SNY/REGN seeking approval for Dupixent in children aged 2 to 11 years with CSU has been accepted for review by the FDA. The final decision is expected by April 2026.

Over the past year, REGN’s shares have gained 14.1% compared with the industry’s 20.1% growth.

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CHMP Nod to SNY/REGN’s Dupixent Based on Phase III Studies

The positive opinion by CHMP for CSU in kids is supported by data from two late-stage studies, Study A and Study C, in the phase III LIBERTY-CUPID program and the phase III 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. Treatment with Dupixent also increased the percentage of patients with well-controlled disease and complete response versus placebo at 24 weeks.

Global Dupixent Growth & Revenue-Sharing Framework

Regeneron has a global strategic collaboration with Sanofi for the discovery, development and commercialization of Dupixent, Kevzara and itepekimab. Under the collaboration 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.

For full-year 2025, Regeneron recorded $5.9 billion in collaboration revenues from Sanofi, mainly for Dupixent, representing 30% year-over-year growth.

For SNY, Dupixent generated global sales of $17.8 billion (€15.7 billion), rising 26% year over year in 2025.

REGN’s Zacks Rank & Stocks to Consider

Regeneron Pharmaceuticals currently has a Zacks Rank #3 (Hold).

Some top-ranked stocks in the biotech sector are Castle Biosciences CSTL, which currently sports a Zacks Rank #1 (Strong Buy) and Assertio Holdings ASRT, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 39% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.

Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have gained 1% over the past year.

Assertio’s earnings beat estimates in one of the trailing four quarters and missed in the remaining three quarters, with the average negative surprise being 35.21%.

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