Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
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.
Regeneron's Phase 2 trial data for odronextamab in relapsed/refractory follicular lymphoma revealed an impressive 82% response rate among patients, with 75% achieving complete responses. The median progression-free survival was reported at 20 months, while overall survival remains not reached. These outcomes are critical for anticipated regulatory submissions in 2023, including to the FDA. The study involved 121 patients, all of whom had undergone prior treatments. Safety evaluations noted adverse events mostly of grade 3 or higher, with cytokine release syndrome being common.
Regeneron Pharmaceuticals announced initial positive data from a pivotal Phase 2 trial for linvoseltamab (200 mg dose) at the ASH Annual Meeting. The trial included patients with high disease burden, showing a 64% response rate and 45% achieving very good partial responses. With a median follow-up of 3 months, results suggest ongoing efficacy and safety. Notably, 95% of patients reported adverse events, with 66% being severe. The complete dataset is under evaluation as the drug aims to address unmet needs in relapsed/refractory multiple myeloma.