Sanofi and Regeneron Announce EU Approval Recommendation for Potential Chronic Spontaneous Urticaria Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 22 2025
0mins
Should l Buy REGN?
Source: Yahoo Finance
Regulatory Update: Sanofi and Regeneron Pharmaceuticals announced that the European Medicines Agency has accepted their application for a new treatment.
Market Implications: This development could potentially impact the companies' stock performance and market positioning in the pharmaceutical industry.
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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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- 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.
- Market Risk Factors: Despite several catalysts propelling stock price growth, a market crash or significant pipeline issues could derail Teva's momentum; however, the company's pipeline is relatively de-risked, and with a forward P/E of only 11.7, it presents a compelling value investment opportunity.
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- 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.
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See More
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- Tolerability Comparison: Sanofi's Nuvaxovid vaccine demonstrated a significantly better tolerability profile in a head-to-head study against Moderna's mNEXSPIKE, with less than 10% of Nuvaxovid recipients experiencing systemic side effects compared to 20% for mNEXSPIKE.
- 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.
- Market Reaction: As of April 17, Sanofi's stock price stood at $48.06, reflecting a 0.71% increase, and further rose to $48.25 in after-hours trading, indicating a positive market response to the vaccine study results.
See More
Teva's FDA Approval of Long-Acting Drug Could Be Major Catalyst
- New Drug Approval Outlook: Teva's New Drug Application for long-acting schizophrenia drug olanzapine has been accepted by the FDA, and if approved, it is expected to significantly enhance patient adherence, driving sales growth and becoming the company's most meaningful catalyst.
- Specialty Drug Sales Surge: Teva's Austedo generated $2.26 billion in sales in 2025, marking a 34% year-over-year increase, with expectations to reach between $2.4 billion and $2.55 billion in 2026, showcasing strong momentum in the specialty drug sector.
- Biosimilar Market Expansion: Teva plans to launch six new biosimilars in 2026 and 2027, potentially competing with Amgen and Johnson & Johnson, which will further solidify its position as the second-largest player in the biosimilar market.
- Investor Confidence Boost: Analysts are optimistic about Teva's future, with 12 out of 15 analysts rating the stock as a
See More
Teva Pharmaceutical Shares Surge 130% with Optimistic Outlook
- FDA Approval Catalyst: Teva's long-acting olanzapine injectable suspension NDA has been accepted by the FDA, with a decision expected later this year; approval could significantly enhance patient adherence, with combined annual sales with Uzedy projected to exceed $2 billion.
- 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.
- Market Risk Factors: Despite several catalysts propelling stock price growth, a market crash or significant pipeline issues could derail Teva's momentum; however, the company's pipeline is relatively de-risked, and with a forward P/E of only 11.7, it presents a compelling value investment opportunity.
See More
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- Clinical Trial Results: AbbVie's March 9 announcement of ABBV-295's clinical trial results indicates that patients receiving weekly treatment lost an average of 7.75% to 9.79% of their weight over 12 weeks, while those on biweekly or monthly regimens lost between 7.86% and 9.73% over 13 weeks, suggesting strong potential for the drug in the weight loss market.
- Competitive Market Pressure: Despite the promising initial data for ABBV-295, AbbVie faces intense competition in the weight loss market from companies like Eli Lilly, which have several late-stage obesity drugs, indicating that the market will become increasingly crowded before AbbVie can launch its product.
- 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
Regeneron and Telix Collaborate on Radiopharmaceuticals
- 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
Dupixent Approved by EU for Pediatric CSU Treatment
- 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
