Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), which recommends extension of the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy. Atopic dermatitis is a chronic inflammatory disease of the skin. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.If approved, Dupixent would be the first biologic medicine available in the EU to treat this patient group.
Shares of Regeneron have surged 59.7% year to date against the industry’s decline of 0.2%.
We note that Dupixent is already approved to treat severe asthma in adults as well as two other type II inflammatory diseases — severe chronic rhinosinusitis with nasal polyposis and moderate-to-severe atopic dermatitis in both the United States and Europe.
Dupixent is the first and only biologic approved for the treatment of uncontrolled moderate-to-severe atopic dermatitis inpeople 12 years and older in the EU and 6 years and older in the United States.
The positive CHMP opinion is supported by data that include pivotal phase III results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) in children aged 6 to 11 years with severe atopic dermatitis that is uncontrolled on topical prescription therapies. In the study, children treated with Dupixent and TCS experienced significantly improved measures of overall disease severity (Eczema Area and Severity Index), skin clearance, itch and health-related quality of life measures compared to TCS alone.
The frequent label expansion approvals are driving the drug’s sales,with the momentum expected to continue in the future quarters as well.
Meanwhile, Dupixent is also being studied for treating other diseases, such as bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis, eosinophilic esophagitis and chronic obstructive pulmonary disease, all in phase III evaluation. It is also being investigated in phase II studies for peanut allergy and grass pollen allergy.
Zacks Rank and Stocks to Consider
Regeneron currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS and Castle Biosciences, Inc. CSTL. While Emergent sports a Zacks Rank #1 (Strong Buy), Castle Biosciences carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $4.23 to $6.61 for 2020 and from $5.55 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 83.2% year to date.
Castle Biosciences’ loss per share estimates have narrowed from 51 cents to 11 cents for 2020 over the past 90 days. Shares of the company have increased 45.4% year to date.
Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. price | Regeneron Pharmaceuticals, Inc. Quote
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