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 has received Emergency Use Authorization (EUA) from the FDA for its monoclonal antibody cocktail, REGEN-COV2, for recently diagnosed, mild to moderate COVID-19 in high-risk patients. The therapy, consisting of casirivimab and imdevimab, is set to be made available at no out-of-pocket cost to approximately 300,000 patients under a U.S. government allocation program. Initial doses will be supplied to around 80,000 patients by the end of November, increasing to 300,000 by January 2021. Clinical trials showed significant reductions in viral levels, particularly in high-risk patients.
Regeneron Pharmaceuticals reported a strong Q3 2020, with revenues rising 32% to $2.29 billion, driven by EYLEA and Dupixent sales. EYLEA net sales increased 11% to $1.32 billion, while Dupixent saw a 69% jump in global net sales to $1.07 billion. GAAP diluted EPS was $7.39, while non-GAAP diluted EPS reached $8.36. The REGN-COV2 trial showed promising results for COVID-19, earning FDA priority review for treatments Libtayo and Inmazeb. Regeneron also announced significant pipeline progress, with over 20 product candidates in development.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a recommendation from the Independent Data Monitoring Committee (IDMC) to pause enrollment in the REGN-COV2 trial for hospitalized patients requiring high-flow oxygen or mechanical ventilation due to safety concerns. However, enrollment for patients requiring low-flow oxygen or no oxygen will continue, as the risk-benefit profile remains acceptable. The IDMC also suggests that the outpatient trial proceed without modification. Regeneron is working with the FDA and is committed to implementing these recommendations.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted the supplemental Biologics License Application for its PD-1 inhibitor, Libtayo (cemiplimab-rwlc), for treating first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The FDA's target decision date is February 28, 2021. This application is based on a Phase 3 trial comparing Libtayo to chemotherapy. The EMA is also reviewing Libtayo, with a decision expected in Q2 2021.
TARRYTOWN, N.Y., Oct. 28, 2020 /PRNewswire/ -- Regeneron reported positive results from a Phase 2/3 trial of its investigational COVID-19 antibody cocktail, REGN-COV2. Data from an additional 524 patients confirmed significant reductions in both viral load and medical visits. The treatment reduced COVID-19 related medical visits by 57% overall and 72% in high-risk patients. Regeneron has submitted these results to the U.S. FDA for Emergency Use Authorization. The trial demonstrated no significant differences in outcomes between high and low doses of REGN-COV2, leading to potential dosing changes in ongoing trials.
Regeneron Pharmaceuticals and Sanofi announced positive results from a pivotal Phase 3 trial of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in patients aged 12 and older. The trial demonstrated significant improvements in patients' ability to swallow, structural abnormalities in the esophagus, and reduced eosinophil counts. Presented at virtual ACG 2020 and UEG Week 2020, the data showed that 64% of patients treated with Dupixent achieved eosinophil levels below the diagnostic threshold. The FDA granted Breakthrough Therapy designation for Dupixent in EoE in September 2020.
Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), extending its approval in the EU for children aged 6 to 11 years with severe atopic dermatitis suitable for systemic therapy. Dupixent, a biologic, is already approved for older patients in the EU and U.S. Efficacy data from Phase 3 trials showed significant improvement in disease measures when combined with topical corticosteroids. A final decision by the European Commission is forthcoming.
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