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About Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is a leading biotechnology company headquartered in Tarrytown, New York. Founded in 1988 by physician-scientists, Regeneron has established itself as a pioneer in the discovery, development, and commercialization of innovative medicines that address serious diseases across diverse therapeutic areas, including ophthalmology, immunology, oncology, hematology, infectious diseases, and rare genetic disorders.
Core Business Areas
Regeneron is renowned for its proprietary VelociSuite® technologies, including VelocImmune®, which enable the rapid and efficient development of fully human monoclonal antibodies and bispecific antibodies. These technologies have fueled the creation of groundbreaking therapies such as:
- EYLEA® (aflibercept): A leading treatment for retinal diseases, including wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
- Dupixent® (dupilumab): A transformative therapy for type 2 inflammatory diseases, including asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps.
- Libtayo® (cemiplimab): A PD-1 inhibitor for advanced cancers, including cutaneous squamous cell carcinoma (CSCC) and non-small cell lung cancer (NSCLC).
In addition to marketed products, Regeneron’s robust pipeline includes investigational candidates targeting hematologic malignancies, cardiovascular diseases, and genetic disorders. Programs such as linvoseltamab for multiple myeloma and DB-OTO for otoferlin-related hearing loss exemplify their commitment to addressing unmet medical needs.
Innovative Drug Discovery and Development
Regeneron’s success is underpinned by its commitment to genetics-driven drug discovery. The Regeneron Genetics Center® (RGC) is one of the world’s most comprehensive DNA-sequencing initiatives, linking genomic data with electronic health records to identify novel therapeutic targets. This unique approach has led to the development of therapies targeting previously untreatable conditions.
Strategic Collaborations
Regeneron collaborates with global pharmaceutical leaders like Sanofi and Bayer to expand the reach of its therapies. These partnerships have enabled the co-development and commercialization of key products such as Dupixent and EYLEA, ensuring accessibility to patients worldwide.
Market Position and Competitive Landscape
Regeneron’s ability to consistently translate science into medicine has positioned it as a leader in the biotechnology industry. Its focus on proprietary technologies, first-in-class therapies, and strategic collaborations differentiates it from competitors. The company’s pipeline, spanning over 40 investigational candidates, underscores its long-term growth potential in a highly competitive market.
Commitment to Patients and Science
Driven by a mission to improve lives, Regeneron combines cutting-edge science with a relentless focus on patient outcomes. Its innovative research platforms, coupled with a deep understanding of disease biology, enable the development of medicines that transform care for millions of patients globally.
Regeneron Pharmaceuticals and Sanofi announce that Dupixent has received European Commission approval for the treatment of eosinophilic esophagitis (EoE) in patients aged 12 and older. Dupixent is now the first targeted medicine available for this chronic inflammatory disease in the EU. In pivotal trials, 60% of patients treated with Dupixent experienced histological remission, significantly improving their swallowing abilities. The treatment shows potential in addressing other conditions related to type 2 inflammation. The safety profile remained consistent, with common side effects including injection site reactions and infections.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Dupixent® (dupilumab), recommending its approval to treat severe atopic dermatitis in children aged 6 months to 5 years. This decision is based on a successful Phase 3 trial showing Dupixent significantly improved skin clearance and reduced disease severity. Currently, about 80,000 children in Europe could benefit from this treatment. The final decision from the European Commission is pending.
On January 24, 2023, Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the finalists of the Regeneron Science Talent Search 2023, recognizing 40 high school seniors for their innovative scientific research. This prestigious competition, celebrating its 82nd year, awards over $1.8 million in prizes, with top awards reaching $250,000. The finalists, chosen from over 1,900 applicants, represent diverse scientific disciplines and address pressing societal issues such as climate change, public health, and social justice. The competition includes a rigorous judging process and culminates in an awards ceremony on March 14, 2023.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the date for its fourth quarter and full year 2022 financial results. The report will be released on February 3, 2023, prior to the U.S. market opening. A conference call and webcast to discuss the results will take place at 8:30 AM Eastern Time on the same day. Participants can join via the company's website or register for phone access. Regeneron focuses on developing innovative medicines, with a strong pipeline aimed at various serious diseases.
Regeneron Pharmaceuticals (NASDAQ: REGN) received marketing and manufacturing authorization from Japan's Ministry of Health for Libtayo® (cemiplimab), marking it as the first approved monotherapy for advanced cervical cancer in the country. This approval follows positive results from the Phase 3 EMPOWER-Cervical 1 trial, which showed significant survival benefits compared to chemotherapy. The global incidence of cervical cancer is rising, with about 600,000 new cases and 350,000 deaths each year. Libtayo was previously approved in the EU for similar indications.
Regeneron Pharmaceuticals and Sanofi announced that a Phase 3 trial of Dupixent (dupilumab) 300 mg weekly for treating eosinophilic esophagitis (EoE) showed significant improvements in patient histology and symptoms compared to placebo. Improvements were sustained for up to one year in patients aged 12 and older. Dupixent is the first U.S. approved targeted treatment for EoE. The FDA approved Dupixent in May 2022, and the EMA has given a positive opinion for its use in Europe. Safety results matched Dupixent's known profile, suggesting a favorable risk-benefit ratio.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that it will webcast its presentation at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 a.m. Pacific Time. Investors can access the presentation via the company's website, with an archived version available for 30 days thereafter. Regeneron, a leading biotechnology firm founded by physician-scientists, develops innovative medicines for serious diseases across various therapeutic areas including eye diseases, cancer, and rare conditions.
Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's Committee has recommended Dupixent for approval to treat adolescents and adults aged 12 and over with eosinophilic esophagitis (EoE). This would make Dupixent the first targeted treatment for EoE in the EU, following its U.S. approval in May 2022. The positive recommendation is based on pivotal trial data showing significant improvements in patients' ability to swallow and histological remission. The European Commission will make a final decision soon.
Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis, marking it the first targeted medicine for this condition in Europe. Clinical trials showed that 60% of Dupixent patients experienced significant itch reduction at 24 weeks, compared to 18% for placebo. The drug also improved skin lesions and overall quality of life. Approximately 70,000 adults in Europe are affected by this chronic skin disease, underscoring the need for effective treatment options.
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