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) announced FDA approval for Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) as the first treatment for Zaire ebolavirus infection in patients of all ages. Inmazeb demonstrated superiority in reducing mortality compared to ZMapp and remdesivir in a clinical trial involving 681 patients. The approval was facilitated by a collaboration with BARDA, ensuring a steady supply for public health emergencies. Regeneron remains committed to making Inmazeb accessible and continues support for Ebola response efforts in affected regions.
Regeneron Pharmaceuticals and Sanofi announced that Dupixent (dupilumab) successfully met its primary and key secondary endpoints in a Phase 3 trial for children aged 6-11 with uncontrolled moderate-to-severe asthma. The study showed Dupixent reduced severe asthma attacks by up to 65% and improved lung function significantly within two weeks. Regulatory submissions in the U.S. and EU for this age group are anticipated by Q1 2021. The safety profile was consistent with previous findings, showing Dupixent as a promising option for children suffering from this serious condition.
Regeneron Pharmaceuticals (NASDAQ: REGN) will report its third quarter 2020 financial results on November 5, 2020, before the U.S. markets open. A conference call and webcast will be held at 8:30 AM ET on the same day. To participate, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International) with conference ID 1535889. Regeneron is known for developing life-transforming medicines and has seven FDA-approved treatments. Its innovative technologies, like VelociSuite, enhance drug development processes.
On September 29, 2020, Regeneron Pharmaceuticals announced promising results from a Phase 1/2/3 trial of REGN-COV2, its investigational antibody cocktail for COVID-19. The study showed significant reductions in viral load and symptom duration among non-hospitalized patients, particularly those without effective immune responses. Results indicated faster symptom alleviation and a favorable safety profile; both high and low doses of REGN-COV2 were well-tolerated. Regeneron plans to discuss these findings with regulatory agencies and host a webcast for investors.
Regeneron Pharmaceuticals and Sanofi presented positive data from a pivotal trial of Libtayo (cemiplimab) for first-line treatment of advanced non-small cell lung cancer (NSCLC) at the ESMO Virtual Congress 2020. Libtayo demonstrated a 32% reduction in risk of death compared to chemotherapy, with a median overall survival of 22 months versus 14 months for chemotherapy. In patients with PD-L1 expression ≥50%, Libtayo showed a 43% reduction in death risk. The drug is being developed under a global collaboration agreement.
Regeneron Pharmaceuticals and Sanofi announced promising results from the Phase 2 trial of Libtayo® (cemiplimab) for advanced basal cell carcinoma (BCC) after hedgehog inhibitor therapy. The trial, presented at the ESMO Virtual Congress 2020, reported a 31% objective response rate (ORR) with 85% of responses ongoing at one year. Key findings include a median follow-up of 15 months, with a probability of overall survival at 92%. No new safety signals were observed, though 17% of patients discontinued treatment due to adverse events. Libtayo is still under investigation for this indication.
Regeneron Pharmaceuticals and the University of Oxford announced the RECOVERY trial to evaluate the investigational COVID-19 treatment REGN-COV2. This Phase 3 trial will compare the addition of REGN-COV2 to the standard care in COVID-19 hospitalized patients, assessing its impact on mortality and hospital stays. The trial aims to include at least 4,000 participants across 176 UK hospitals. The success of REGN-COV2 could provide significant insights into effective treatment options for COVID-19, complementing existing therapies like dexamethasone.
Regeneron Pharmaceuticals and Sanofi announced that the FDA granted Breakthrough Therapy designation to Dupixent for treating eosinophilic esophagitis (EoE) in patients 12 and older. This designation follows positive results from a Phase 3 trial, where Dupixent met its primary and secondary endpoints, showcasing significant symptom reduction and improved esophageal health. With approximately 160,000 patients in the U.S. affected by EoE and no FDA-approved treatments, this designation highlights Dupixent's potential as a first-in-class therapy for this chronic condition.
Regeneron Pharmaceuticals and Sanofi announced results from a Phase 3 open-label extension trial for Dupixent, the largest study of a biologic in asthma with over 2,200 patients. Results indicate sustained improvements in lung function and reduced severe asthma attacks over three years. The average change in FEV1 was 13-22%, with low rates of severe attacks averaging 0.31-0.35 events per year. Safety profiles showed AE rates consistent with previous trials. The data emphasizes Dupixent's role as a long-term treatment option for patients suffering from moderate-to-severe asthma.
Sanofi and Regeneron Pharmaceuticals (NASDAQ: REGN) will present promising data for Libtayo® (cemiplimab) at the ESMO Virtual Congress 2020 from September 19-21. Key highlights include late-breaking oral presentations on Libtayo monotherapy for first-line advanced non-small cell lung cancer (NSCLC) and advanced basal cell carcinoma (BCC) post-hedgehog inhibitor treatment. The clinical trials demonstrate Libtayo's effectiveness across various cancers, which may support regulatory submissions in the U.S. and EU. Additional presentations will focus on patient quality of life and treatment demographics.
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