Dupixent Approved in EU for CSU Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Should l Buy REGN?
Source: NASDAQ.COM
Regeneron Pharmaceuticals and Sanofi have received approval for Dupixent in the EU as the first innovative treatment for chronic spontaneous urticaria (CSU). This approval fills a significant gap in treatment options that has persisted for over a decade, promising to enhance the quality of life for approximately 270,000 patients in the region.
The approval is based on the successful LIBERTY-CUPID Phase 3 clinical trials, which demonstrated significant reductions in urticaria activity over 24 weeks. This positions Dupixent as a first-line treatment option for patients who have not adequately responded to standard antihistamine therapies.
With the introduction of Dupixent, Regeneron and Sanofi are poised to capture a substantial share of the market, addressing the needs of patients who have been underserved by existing treatments. The safety profile of Dupixent aligns with known characteristics, ensuring its acceptability in clinical use.
This development not only represents a breakthrough for patients but also signals potential revenue growth for Regeneron as they expand their market presence in chronic inflammatory diseases.
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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: 746.000
Low
637.00
Averages
808.50
High
1057
Current: 746.000
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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See More
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- Side Effect Rates: The COMPARE study revealed that 83.6% of Nuvaxovid recipients experienced systemic reactions, while 91.6% of mNEXSPIKE recipients did, highlighting Nuvaxovid's advantage in side effects, which may enhance vaccine confidence.
- Patient Feedback: Participants reported less disruption to work, school, and daily activities after receiving Nuvaxovid, with nearly twice as many Nuvaxovid recipients indicating they would choose the same vaccine again, underscoring the impact of tolerability on vaccination behavior.
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- Specialty Drug Sales Surge: Teva's specialty drug Austedo generated $2.26 billion in sales in 2025, a 34% year-over-year increase, with expectations for 2026 sales to rise between $2.4 billion and $2.55 billion, reflecting strong market demand and competitive positioning in the specialty drug sector.
- Biosimilar Expansion: Teva plans to launch six new biosimilars in 2026 and 2027, further solidifying its position as the second-largest player in the biosimilar market, with anticipated competition against giants like Amgen and Johnson & Johnson, driving future revenue growth.
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See More
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- Core Business Stability: AbbVie's primary therapeutic area remains immunology, with projected sales for Skyrizi and Rinvoq exceeding $31 billion in 2023, significantly surpassing Humira's peak sales, demonstrating the company's robust performance and growth potential in this sector.
- Optimistic Pipeline Outlook: Even if ABBV-295 fails in clinical trials, AbbVie has a deep pipeline of investigational products, including the ongoing ABBV-383 cancer treatment, which is expected to provide significant support for the company's future financial performance and further solidify its leadership in the pharmaceutical industry.
See More
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- Collaborative Drug Development: Regeneron and Telix have established a 50/50 cost and profit-sharing collaboration to develop next-generation radiopharmaceuticals, marking a strategic partnership in innovative drug development.
- Upfront Payment Structure: Telix will receive an upfront payment of $40 million, granting Regeneron access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, highlighting Regeneron's commitment to new therapies.
- Potential Earnings and Milestones: Should Telix opt out of co-funding for any individual program, it remains eligible for up to $535 million in development and commercial milestone payments, along with low double-digit royalties on future sales, reflecting the long-term value of the collaboration.
- Commercialization and Diagnostic Programs: Telix will lead commercialization efforts while Regeneron shares in the profits, and both companies will jointly work on diagnostic programs, further expanding the depth and breadth of their collaboration.
See More
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- Approval Expansion: The European Commission has approved Dupixent (Dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years, marking a significant expansion of the drug's indications to address the urgent needs of children unresponsive to antihistamines.
- Clinical Trial Support: This approval is based on data from the LIBERTY-CUPID clinical trial program, which demonstrated that Dupixent significantly reduced urticaria activity in adults, further validating its efficacy and safety in the pediatric population.
- Global Market Performance: Dupixent has received regulatory approvals in over 60 countries, with Sanofi reporting global net sales of $17.8 billion for 2025, a significant increase from the previous year, indicating strong market demand and potential for the drug.
- Market Reaction: Despite the positive approval news, Sanofi's stock fell 0.68% in Friday's trading and continued to decline by 0.97% in pre-market trading, reflecting a cautious market sentiment towards the biopharmaceutical sector.
See More
