Dupixent Approved for Young Children with Chronic Urticaria
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 12 hours ago
0mins
Should l Buy REGN?
Source: seekingalpha
- Pediatric Indication Expansion: Sanofi and Regeneron's Dupixent has been approved in the U.S. as the first biologic for children aged 2 to 11 with uncontrolled chronic spontaneous urticaria (CSU), marking a significant expansion in its pediatric indications that is expected to substantially boost market demand and company revenues.
- Clinical Research Support: The approval is primarily based on data from the LIBERTY-CUPID clinical study program, demonstrating Dupixent's efficacy in children who remain symptomatic despite H1 antihistamine treatment, thereby reinforcing its position in the chronic skin disease treatment landscape and enhancing the company's competitive edge in the biopharmaceutical market.
- Safety Consistency: Safety results from all four CSU studies were generally consistent with Dupixent's known safety profile in its approved dermatological indications, with no new adverse reactions identified in children aged 2 to 11, ensuring market acceptance and physician trust in the product.
- Significant Market Potential: Dupixent is now approved for five diseases driven in part by type 2 inflammation in children, and with the rising number of pediatric CSU patients, it is projected to generate substantial long-term revenue for Sanofi and Regeneron, further solidifying their leadership in the pediatric biologics market.
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Analyst Views on REGN
Wall Street analysts forecast REGN stock price to rise
22 Analyst Rating
16 Buy
6 Hold
0 Sell
Moderate Buy
Current: 746.580
Low
637.00
Averages
808.50
High
1057
Current: 746.580
Low
637.00
Averages
808.50
High
1057
About REGN
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company. The Company invents, develops, manufactures, and commercializes medicines for people with serious diseases. Its products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. The Company is accelerating drug development using its proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. VelociSuite consists of VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, VelociHum, and other related technologies. Its marketed products include EYLEA (aflibercept); Dupixent (dupilumab); Libtayo (cemiplimab); Ordspono (odronextamab); Kevzara (sarilumab); Itepekimab; Lynozyfic, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Profit Growth: Quarterly business operating income reached €2.97 billion ($3.47 billion), exceeding the average analyst estimate of €2.85 billion, reflecting significant progress in cost control and operational efficiency.
- Dupixent Sales Surge: Sales of Dupixent rose by 30.8% to €4.17 billion ($4.88 billion), far exceeding analysts' expectations of €3.89 billion, demonstrating sustained demand for the drug in asthma and eczema treatment, thereby reinforcing Sanofi's market position.
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- Eligible Patient Population: The therapy is available for adults and children with biallelic variants in the OTOF gene, particularly those with severe-to-profound sensorineural hearing loss who have not undergone cochlear implantation in the same ear, potentially offering new treatment options for this demographic.
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- Clinical Trial Results: In the CHORD trial, 80% of participants achieved hearing improvements within 24 weeks, and 42% achieved normal hearing by 48 weeks, demonstrating the therapy's efficacy and potential for widespread application.
- Innovative Treatment: Otarmeni restores hearing by delivering a functional OTOF gene into the cochlea, providing a novel treatment option, particularly significant for the approximately 50 newborns affected by OTOF-related hearing loss each year, highlighting its clinical importance.
- Free Provision: Regeneron commits to providing Otarmeni at no cost to eligible patients in the U.S., reflecting the company's dedication to improving patient lives and potentially driving broader adoption of gene therapies among diverse populations.
See More
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- FDA Approval Imminent: The company is poised to receive FDA approval for a therapy targeting ultra-rare hereditary hearing loss caused by a gene mutation, which will add a new treatment option to its product line and further solidify its position in the biopharmaceutical sector.
- Policy Context: In May 2025, Trump issued an executive order directing the Department of Health and Human Services to implement the MFN policy aimed at lowering U.S. brand-name prescription drug prices to levels seen in other developed countries, highlighting the government's strong focus on drug pricing.
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See More
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