FDA Approves Dupixent for Treatment of CSU in Children Aged 2 to 11
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20 hours ago
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Should l Buy REGN?
Source: Newsfilter
- New Treatment Option for Children: Dupixent (dupilumab) has received FDA approval as the first biologic for chronic spontaneous urticaria (CSU) in children aged 2 to 11, addressing a significant treatment gap and expected to greatly enhance their quality of life.
- Clinical Trial Support: The approval is primarily based on data from the LIBERTY-CUPID clinical trial program, demonstrating Dupixent's efficacy in reducing itch severity and urticaria activity, particularly in patients aged 12 and older, thereby enhancing its applicability in younger populations.
- Strong Market Demand: Over 14,000 children aged 2 to 11 in the U.S. suffer from uncontrolled CSU symptoms, and Dupixent's approval provides a new treatment avenue for these patients, likely driving growth in the pediatric allergy treatment market.
- Strategic Implications: With approvals for nine allergy-related conditions, the FDA's authorization reinforces Dupixent's established safety and efficacy profile, potentially transforming treatment paradigms for chronic diseases and strengthening Regeneron and Sanofi's competitive position in the 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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See More
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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.
- Clinical Trial Support: Data from the company's CHORD trial indicates that 16 out of 20 subjects exceeded a predetermined hearing level 24 weeks after receiving Otarmeni, demonstrating the therapy's efficacy and laying the groundwork for future market introduction.
- Conditions for Continued Approval: The ongoing approval of the drug will depend on positive results from the confirmatory trial, which is currently enrolling patients in countries including the U.S. and the U.K., reflecting Regeneron's commitment to further validating the therapy's effectiveness.
See More
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- Clinical Benefit Verification: While Otarmeni has received approval, its continued status hinges on demonstrating clinical benefits in the confirmatory phase of the CHORD trial, indicating that Regeneron must conduct further research to ensure the therapy's efficacy and safety.
- Drug Pricing Strategy: Regeneron plans to list its cholesterol-lowering drug Praluent on the TrumpRx website for $225, showcasing the company's flexibility in drug pricing and reflecting its collaborative relationship with the Trump administration.
- Positive Market Reaction: Although REGN stock is down 1% year-to-date, it has risen 30% over the past 12 months, indicating investor optimism regarding the company's new therapy, especially following FDA approval, which has heightened expectations for future growth.
See More
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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.
- Industry Response: So far, 16 leading pharmaceutical companies, including Pfizer (PFE) and Eli Lilly (LLY), have agreed to Trump's demands by offering lower prices for some drugs in exchange for tariff waivers, a trend that may influence pricing strategies across the entire pharmaceutical industry.
See More
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- Operating Income Increase: The company’s operating income for the first quarter reached €2.97 billion, surpassing the forecast of €2.85 billion, reflecting robust growth in its core business that may enhance future shareholder returns.
- Strong Dupixent Sales: Sales of Dupixent surged 30.8% year-over-year to €4.17 billion, comfortably beating analysts' forecast of €3.89 billion, demonstrating sustained strong demand for the drug in asthma and eczema treatment.
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