Key Developments: Regeneron Pharmaceuticals Inc (REGN.O)
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Latest Key Developments (Source: Significant Developments)
Sanofi SA and Regeneron Pharmaceuticals Inc Announce Positive Phase 2a Results of Dupilumab in Asthma
Sanofi SA and Regeneron Pharmaceuticals Inc announced that the New England Journal of Medicine published online the positive Phase 2a study results of dupilumab in patients with moderate-to-severe allergic asthma. Dupilumab is an investigational monoclonal antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), which modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response. The proof-of-concept study enrolled 104 patients with moderate-to-severe, persistent asthma that was not well controlled with inhaled glucocorticosteroids (ICS) and long-acting beta agonist (LABA) therapy, and who had elevated blood or sputum eosinophils (immune cells used as a marker of Th2 asthma in this study). The primary objective of the trial was to assess the effect of dupilumab, dosed subcutaneously, weekly at 300 milligrams (mg) for twelve weeks. Patients were treated with dupilumab (N=52) or placebo (N=52) on top of ICS and LABA therapy for the first four weeks of the study. 23 patients (44.2%) receiving placebo experienced an asthma exacerbation compared to three patients (5.8%) receiving dupilumab, resulting in an 87% reduction in the incidence of asthma exacerbations for the dupilumab arm compared to placebo (p<0.0001). Improvements were observed for lung function and other asthma control parameters, such as forced expiratory volume over one second. Full Article
Regeneron Pharmaceuticals Inc Settles All Pending Litigation With Roche Holding AG's Genentech-Reuters
Reuters reported that Regeneron Pharmaceuticals Inc said it settled all pending litigation with Roche Holding AG's unit Genentech on the company's eye drug, Eylea, and cancer drug, Zaltrap. Full Article
Sanofi SA and Regeneron Pharmaceuticals Inc Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis
Sanofi SA and Regeneron Pharmaceuticals Inc announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, have enrolled their first patients. The broad SARIL-RA clinical development program is focused on adult populations with moderate to- severe rheumatoid arthritis (RA) who are inadequate responders to either methotrexate (MTX) or tumor necrosis factor alpha (TNF-alpha) inhibitor therapy. The SARIL-RA program is comprised of the following five trials: SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARILRA ASCERTAIN, and an open-label extension trial, SARIL-RA EXTEND. The program is targeted to enroll approximately 2,600 patients with moderate-to-severe rheumatoid arthritis. The primary objective of the overall Phase 3 program is to determine the safety and efficacy of sarilumab in reducing the signs and symptoms of RA, as well as inhibiting disease progression, in a broad range of patients. Two doses of sarilumab are being studied in the SARIL-RA program: 150 milligrams (mg) every other week and 200mg every other week. The SARIL-RA ASCERTAIN trial is a multi-center, randomized, double-blind, active-calibrator, Phase 3 trial of 24 weeks that will assess the safety and tolerability of sarilumab and tocilizumab. Full Article
Sanofi SA and Regeneron Pharmaceuticals, Inc. Announce Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis
Sanofi SA and Regeneron Pharmaceuticals, Inc. announced pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha). The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. The efficacy data showed that treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms of patients with moderate-to-severe atopic dermatitis (AD) whose disease was not adequately controlled with topical medications. Specifically, patients treated with dupilumab had significant improvements in body surface area (BSA) score, Investigator Global Assessment (IGA) score, and Eczema Area Severity Index (EASI) from baseline to week 4 compared to placebo (p<0.05 vs. placebo for all measures and doses). The significant improvements in BSA, IGA, and EASI scores were maintained at week 8 in the 300mg dose group (p<0.05 vs. placebo). A responder analysis demonstrated that at week 4, 54.5% of patients treated with the 150mg dose and 71.4% of patients treated with the 300mg dose achieved a reduction in EASI score of 50% or greater compared to 18.8% with placebo (p<0.05). The most common adverse events (AEs) were nasopharyngitis (19.6% vs 12.5% for placebo) and headache (11.8% vs 6.3% for placebo). Full Article
Regeneron Pharmaceuticals Inc And Bayer AG's Bayer HealthCare Initiate Phase 3 Trial Of EYLEA (aflibercept) Injection For Treatment Of Diabetic Macular Edema In Asia And Russia REGN
Regeneron Pharmaceuticals Inc and Bayer AG's Bayer HealthCare announced that they have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries. The companies are extending their global development program for EYLEA in DME after promising results in the global Phase 2 DME program. Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales. Full Article
Sanofi SA To Increase Stake in Regeneron Pharmaceuticals Inc-Reuters
Reuters reported that Sanofi SA is to buy more shares in Regeneron Pharmaceuticals Inc. Sanofi controls 16.7% of Regeneron, or 15.82 million shares, according to Reuters data. Sanofi said in an email that it has the right to raise the stake to as much as 30% under its decade-long partnership with Regeneron. Full Article
Sanofi SA and Regeneron Pharmaceuticals Inc's ZALTRAP Receive Marketing Authorization from European Union
Sanofi SA announced that with Regeneron Pharmaceuticals Inc the European Commission (EC) has granted marketing authorization in the European Union for ZALTRAP 25mg/ml concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. This decision was based on the efficacy and safety results of the VELOUR Phase 3 trial. Full Article
Regeneron Pharmaceuticals Inc And Bayer AG's Bayer HealthCare Submits Application For Marketing Authorization In Europe For EYLEA (aflibercept) Injection
Regeneron Pharmaceuticals Inc and Bayer AG's Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for EYLEA (aflibercept) Injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO). The submission of EYLEA for Macular Edema following CRVO is based on data from the Phase 3 COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts. The EYLEA 2 milligrams (mg) monthly group was significantly superior to the sham control group for the primary endpoint. The effects were largely maintained until week 52. Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA. Full Article
Regeneron Pharmaceuticals Inc Announces Approval For EYLEA (aflibercept) Injection For Treatment Of Wet Age-Related Macular Degeneration In Europe
Regeneron Pharmaceuticals Inc announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). According to the European Medicines Agency (EMA) approved Summary of Product Characteristics, EYLEA treatment is initiated with one 2 milligram (mg) injection per month for three consecutive months, followed by one injection every two months. There is no requirement for monitoring by the physician between injections. After the first twelve months of treatment with EYLEA, the treatment interval may be extended based on visual and anatomic outcomes. In such cases, the frequency of monitoring visits is determined by the treating physician and may be more often than the schedule of injections. Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales. Full Article
Sanofi SA and Regeneron Pharmaceuticals Inc Announce Patient Enrollment in Cardiovascular Outcomes Trial with Antibody to PCSK9 for Hypercholesterolem
Sanofi SA and Regeneron Pharmaceuticals Inc announced that the Odyssey Outcomes trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, 11 trials are recruiting in the global SAR236553/REGN727 Phase 3 program. Odyssey Outcomes is a double-blind, randomized, placebo-controlled, multi-national study. The primary objective of the study is to evaluate the effect of SAR236553/REGN727 on the incidence of cardiovascular events in patients who have experienced an ACS and are not at their LDL-C goal. Patients will receive either a one-milliliter (mL) injection of 75 milligrams (mg) of SAR236553/REGN727 or placebo every two weeks, in addition to their background of optimized lipid-lowering therapy. If patients do not reach a predetermined LDL-C goal with the 75 mg dose they will be up-titrated to a dose of 150 mg, also delivered as a one mL injection. The primary endpoint is a composite of coronary heart disease (CHD) death, non-fatal MI, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization. Odyssey Outcomes is being conducted under a Special Protocol Assessment (SPA) agreed upon with the US Food and Drug Administration (FDA). Full Article
Regeneron settles all pending litigation with Roche's Genentech
May 20 - Regeneron Pharmaceuticals Inc said it settled all pending litigation with Roche Holding AG's unit Genentech on the company's eye drug, Eylea, and cancer drug, Zaltrap.
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