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Regeneron
(NASDAQ:REGN)
Regeneron (REGN) vs. SPDR S&P 500 ETF (SPY)
Regeneron Business Overview & Revenue Model
Regeneron Key Performance Indicators (KPIs)
Shows how revenue is distributed across different business units, highlighting which areas are driving growth and which might need strategic adjustments.
Main Street DataRegeneron Earnings Call Summary
Regeneron Financial Statement Overview
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 14.25B | 14.20B | 13.12B | 12.17B | 16.07B | 8.50B |
| Gross Profit | 12.17B | 12.23B | 10.87B | 10.47B | 13.35B | 7.14B |
| EBITDA | 5.71B | 5.32B | 4.69B | 5.26B | 9.67B | 4.10B |
| Net Income | 4.58B | 4.41B | 3.95B | 4.34B | 8.08B | 3.51B |
Balance Sheet | ||||||
| Total Assets | 40.17B | 37.76B | 33.08B | 29.21B | 25.43B | 17.16B |
| Cash, Cash Equivalents and Short-Term Investments | 8.44B | 9.01B | 10.84B | 7.74B | 5.69B | 3.59B |
| Total Debt | 2.71B | 2.70B | 2.70B | 2.70B | 2.70B | 2.70B |
| Total Liabilities | 9.21B | 8.41B | 7.11B | 6.55B | 6.67B | 6.14B |
| Stockholders Equity | 30.96B | 29.35B | 25.97B | 22.66B | 18.77B | 11.03B |
Cash Flow | ||||||
| Free Cash Flow | 4.15B | 3.66B | 3.67B | 4.42B | 6.53B | 2.00B |
| Operating Cash Flow | 5.07B | 4.42B | 4.59B | 5.01B | 7.08B | 2.62B |
| Investing Cash Flow | -498.80M | -2.47B | -3.19B | -3.78B | -5.38B | -70.60M |
| Financing Cash Flow | -4.07B | -2.20B | -1.79B | -1.01B | -1.01B | -1.97B |
Regeneron Technical Analysis
Regeneron Risk Analysis
Regeneron Peers Comparison
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
| ― | $17.70B | 15.13 | 30.39% | ― | 18.09% | 3563.21% | |
| ― | $68.61B | 15.67 | 15.19% | 0.40% | 2.89% | 0.50% | |
| ― | $50.39B | 38.98 | 24.75% | ― | 89.58% | ― | |
| ― | $106.97B | 29.82 | 22.77% | ― | 10.38% | ― | |
| ― | $63.13B | -195.21 | -257.82% | ― | 5.01% | -330.09% | |
| ― | $24.85B | ― | -1.81% | ― | 7.51% | 30.53% | |
| ― | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
Regeneron Corporate Events
Study Overview: Regeneron Pharmaceuticals recently completed a study titled Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry. The study aimed to describe and estimate the incidence of retinal vasculitis (RV) events among patients receiving aflibercept intravitreal (IVT) therapy in US clinical practice, highlighting the significance of monitoring adverse effects in real-world settings.
Regeneron Pharmaceuticals faces significant risks due to tariffs and trade restrictions, which could materially impact its operations and financial health. The imposition of tariffs by the United States and other countries, including potential new tariffs on pharmaceutical imports, poses a threat to the company’s supply chain and cost structure. Although pharmaceutical products are currently exempt from certain tariffs, the raw materials necessary for production are not, leading to increased operational costs. Additionally, ongoing investigations and trade agreements could further complicate the situation, potentially resulting in higher tariffs and retaliatory measures that may adversely affect Regeneron’s financial condition.
Regeneron Pharmaceuticals is a biotechnology company that develops and commercializes innovative medicines for serious diseases, utilizing proprietary technologies to advance drug development across various therapeutic areas. In its third quarter of 2025, Regeneron reported a 1% increase in revenues, reaching $3.75 billion, with notable growth in Dupixent sales and new FDA approvals for key treatments. The company’s financial performance was marked by a 9% increase in GAAP net income, although non-GAAP net income saw a decline. Regeneron highlighted strategic advancements, including FDA approvals for Libtayo and Evkeeza, and promising clinical trial results in several therapeutic areas. Looking ahead, Regeneron remains focused on advancing its late-stage pipeline and maintaining solid financial performance, with continued investments in innovation and shareholder value.
Regeneron Pharmaceuticals’ recent earnings call painted a picture of a company experiencing robust growth in key areas, yet facing some operational challenges. The sentiment was largely positive, with strong sales growth in products like Dupixent and Libtayo, and significant progress in their R&D pipeline. However, issues such as affordability challenges for EYLEA and FDA-related setbacks highlighted areas needing attention. Overall, Regeneron maintains a strong financial position and a commitment to innovation.
Regeneron Pharmaceuticals is initiating a study titled ‘A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment.’ The study aims to assess the safety and tolerability of the experimental drug REGN7041 in treating inflammation inside the eye without infection. This first-in-human trial will explore potential side effects, drug levels in blood and eye fluid, and the body’s immune response to the drug.
Study Overview: Regeneron Pharmaceuticals is conducting a first-in-human study titled ‘First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Intrathecally Administered ALN-SNCA in Participants With Early Parkinson’s Disease.’ The study aims to assess the safety and tolerability of ALN-SNCA, an experimental drug, in individuals with early-stage Parkinson’s disease, a condition characterized by the harmful accumulation of α-synuclein protein in the brain.
Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)’. The study aims to evaluate the effectiveness of REGN7508 in preventing venous thromboembolism (VTE) in adults undergoing elective total knee replacement surgery, compared to acetylsalicylic acid (ASA).
Regeneron Pharmaceuticals is conducting a pivotal study titled ‘A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ALN-CFB, an Investigational siRNA Therapeutic Against Complement Factor B, in Participants With Paroxysmal Nocturnal Hemoglobinuria and Persistent Anemia on Approved C5-Inhibitor Therapy.’ This study aims to assess the safety and tolerability of ALN-CFB in adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who continue to experience anemia despite being on a C5 inhibitor. The study’s significance lies in its potential to offer a new therapeutic option for this patient population.
Regeneron Pharmaceuticals and Sanofi SA have initiated a new clinical study titled ‘An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Children ≥6 to <12 Years of Age With Severe Atopic Dermatitis Treated With Dupilumab.' The study aims to evaluate whether dupilumab, an approved treatment for atopic dermatitis, can improve growth and bone strength in children with severe cases that are not well-managed by topical treatments. Additionally, the study will monitor potential side effects of dupilumab.
Regeneron Pharmaceuticals has announced a new clinical study titled ‘A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)’. The study aims to assess the safety and efficacy of two experimental drugs, REGN7508 and REGN9933, in preventing blood clots in patients with atrial fibrillation, comparing their effects to the existing drug, Apixaban.
Study Overview: Regeneron Pharmaceuticals and Sanofi have completed a Phase 3 clinical study titled Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study aimed to assess the efficacy, safety, and tolerability of Itepekimab in reducing acute exacerbations of COPD in former smokers, with secondary objectives including improvements in pulmonary function and quality of life.
Regeneron Pharmaceuticals and Sanofi recently completed a Phase 3 study titled ‘Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).’ The study aimed to assess the effectiveness of itepekimab in reducing the rate of acute COPD exacerbations in former smokers, alongside evaluating its impact on pulmonary function, respiratory symptoms, and overall quality of life.
Study Overview: Regeneron Pharmaceuticals initiated a study titled ‘Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy.’ The study aimed to evaluate the safety and tolerability of garetosmab in healthy obese individuals, focusing on its effects on blood clotting, hormone levels, and potential antibody development against the drug.
Regeneron Pharmaceuticals has been conducting a clinical study titled ‘A Phase 1/2 Study of bbT369, a Dual Targeting CAR T Cell Drug Product With a Gene Edit, in Relapsed and/or Refractory B Cell Non-Hodgkin’s Lymphoma (NHL).’ The study aims to evaluate the safety and efficacy of bbT369, a novel CAR T cell therapy, in patients with relapsed or refractory B cell NHL, a significant area of unmet medical need.
Regeneron Pharmaceuticals is conducting a critical study titled ‘A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients With Generalized Lipodystrophy.’ The study aims to evaluate the effectiveness and safety of mibavademab, a new drug, in treating Generalized Lipodystrophy (GLD) in both adults and children. This research is significant as it explores the drug’s impact on blood sugar, triglycerides, liver fat, and potential antibody development against the drug.
Regeneron Pharmaceuticals is initiating a new clinical study titled ‘An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene.’ The study aims to evaluate the effectiveness and safety of mibavademab in treating monogenic obesity, a condition caused by leptin gene mutations that impair hunger regulation. Key objectives include assessing weight control, drug concentration in the blood, and potential side effects.
Regeneron Pharmaceuticals recently updated its clinical study titled A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Multiple Dose Regimen of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Participants With Uncontrolled Hypertension. The study aimed to assess the effectiveness of REGN5381 in reducing blood pressure in patients with uncontrolled hypertension. Key objectives included evaluating the drug’s safety, side effects, and pharmacokinetics.
Study Overview: The Cemiplimab Survivorship Epidemiology (CASE) Study, conducted by Regeneron Pharmaceuticals, aims to evaluate the effectiveness and safety of cemiplimab in treating advanced cutaneous squamous cell carcinoma (CSCC) and basal cell carcinoma (BCC) in real-world settings. The study focuses on patient outcomes, safety, and treatment patterns, providing valuable insights into the drug’s performance outside of controlled clinical trials.
Study Overview: Regeneron Pharmaceuticals, in collaboration with Bayer, has completed an extension study titled An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090. The study aims to assess the long-term effects of treatments administered in the FIREFLEYE study, focusing on the condition known as Retinopathy of Prematurity (ROP), a serious eye disorder affecting premature infants.
Study Overview: Regeneron Pharmaceuticals recently completed a study titled ‘Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study.’ The study aimed to estimate the incidence of Retinal Vasculitis (RV) and RV plus Intraocular Inflammation (IOI) in patients treated with aflibercept 2mg injections, providing crucial insights into the safety profile of this widely used therapy.
Regeneron Pharmaceuticals recently updated its clinical study investigating the safety and tolerability of odronextamab, officially titled ‘An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)’. The study aims to assess the potential of odronextamab in treating CD20+ B-cell malignancies, such as Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, which are significant due to their prevalence and treatment challenges.
Study Overview: Alnylam Pharmaceuticals, in collaboration with Regeneron Pharmaceuticals, is conducting a Phase 1 study titled A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer’s Disease. The study aims to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of ALN-5288 in patients with Alzheimer’s Disease, marking a significant step in addressing this challenging condition.
Regeneron Pharmaceuticals is conducting a clinical study titled ‘A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors.’ The study aims to evaluate the safety, tolerability, and optimal dosing of REGN7075, alone and in combination with cemiplimab, for treating advanced solid tumors. This research is significant as it explores new treatment avenues for difficult-to-treat cancers.
Study Overview: Regeneron Pharmaceuticals is conducting a study titled ‘Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613.’ The study aims to evaluate the long-term safety and effectiveness of the drug combination fianlimab and cemiplimab in patients with advanced melanoma. This research is significant as it seeks to understand the prolonged impact of these treatments on patient health and cancer progression.
Regeneron Pharmaceuticals is conducting a clinical study titled ‘A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels.’ The study aims to evaluate the effectiveness of combining fianlimab with cemiplimab and chemotherapy compared to the combination of cemiplimab and chemotherapy alone in treating advanced NSCLC.
Regeneron Pharmaceuticals is currently conducting a study titled ‘A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%’. The study aims to evaluate the effectiveness of combining fianlimab with cemiplimab compared to cemiplimab alone in treating advanced NSCLC, focusing on treatment efficacy, side effects, and quality of life improvements.
Study Overview: The MAGNITUDE-2 study, officially titled A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN), aims to assess the efficacy and safety of NTLA-2001. This study is significant as it targets a genetic disorder affecting the nervous system, potentially offering new hope for patients with ATTRv-PN.
Regeneron Pharmaceuticals is conducting a Phase 2 clinical study titled A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma. The study aims to evaluate the effectiveness of combining fianlimab and cemiplimab versus using cemiplimab alone in treating high-risk, resectable melanoma. The study’s significance lies in its potential to enhance treatment outcomes for melanoma patients.
Regeneron Pharmaceuticals is conducting a Phase 2 study titled ‘Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma.’ This study aims to evaluate the safety and effectiveness of linvoseltamab in preventing the progression of high-risk smoldering multiple myeloma (HR-SMM) to multiple myeloma (MM). The significance of this study lies in its potential to offer a new therapeutic option for patients at high risk of developing MM.
Regeneron Pharmaceuticals is conducting a Phase 2 study titled A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma. The study aims to assess the effectiveness of linvoseltamab in eliminating abnormal plasma cells in patients at moderate risk of developing multiple myeloma, focusing on those with precancerous conditions like HR-MGUS and NHR-SMM.
Regeneron Pharmaceuticals is conducting a clinical study titled ‘A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis.’ The study aims to evaluate the safety and efficacy of linvoseltamab, an experimental drug, in treating patients whose AL amyloidosis has returned or is unresponsive to other treatments. This research is significant as it explores potential new treatment avenues for a challenging condition.
Regeneron Pharmaceuticals is conducting a Phase 1/2 study titled ‘Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma.’ The study aims to evaluate the safety and optimal dosing of linvoseltamab, a potential treatment for multiple myeloma, while also assessing its efficacy in combating cancer. The significance of this study lies in its potential to offer new therapeutic options for patients with relapsed or refractory multiple myeloma.
Regeneron Pharmaceuticals is launching a Phase 2 clinical study titled ‘A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC).’ The study aims to evaluate the effectiveness and safety of two drugs, ubamatamab and REGN7075, in treating advanced or metastatic NSCLC. Additionally, the study will assess the use of sarilumab to manage immune-related side effects associated with ubamatamab.
Regeneron Pharmaceuticals is conducting a study titled A Single Arm Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Control of Intravascular Hemolysis on Currently Available C5 Inhibitor Therapy. The study aims to assess the effectiveness and safety of a combination of two experimental drugs, pozelimab and cemdisiran, in treating Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients who have not responded well to existing C5 inhibitors.
Study Overview: The MAGNITUDE study, officially titled MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM), aims to assess the efficacy and safety of NTLA-2001. This study is significant as it targets Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM), a condition that affects the heart and can lead to severe health issues.
Regeneron Pharmaceuticals is conducting a Phase 1 clinical trial titled ‘A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)’. The study aims to evaluate the safety and tolerability of the experimental drugs REGN5837 and odronextamab in treating aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs), with the goal of determining the recommended dose for phase 2 trials.
Regeneron Pharmaceuticals is currently conducting a clinical study titled ‘Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma.’ The study aims to evaluate the safety, tolerability, and effectiveness of linvoseltamab in adults with newly diagnosed multiple myeloma who have not yet received treatment. This research is significant as it explores a potential new treatment avenue for multiple myeloma, a challenging condition to treat effectively.
Regeneron Pharmaceuticals and Sanofi are conducting a Phase 2 clinical study titled ‘A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis.’ The study aims to evaluate how well dupilumab works in treating eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD), focusing on symptom relief and inflammation reduction over a period of 24 to 52 weeks.
Study Overview: Regeneron Pharmaceuticals is conducting a clinical study titled An Open-Label, Single-Arm Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Pozelimab in Pediatric Patients 1 to 5 Years of Age With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease). The study aims to assess the safety and tolerability of the drug pozelimab in young children suffering from CHAPLE, a rare and potentially life-threatening hereditary disease affecting the gastrointestinal and cardiovascular systems.
Regeneron Pharmaceuticals is conducting a study titled ‘A Prospective Study to Evaluate Disease Characteristics in Hemophilia B Participants Receiving Prophylaxis With Standard of Care FIX Replacement Therapy.’ The study aims to gather comprehensive data on bleeding events in adult males with Hemophilia B who are on standard FIX replacement therapy. This observational study is significant as it seeks to understand individual disease characteristics and could inform future experimental therapies.
Regeneron Pharmaceuticals is conducting a Phase 2 clinical study titled ‘A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors.’ The study aims to evaluate the effects of the investigational drug ALN-HSD on reducing liver scarring in patients with MASH, a chronic liver disease. This research is significant as it targets a condition that can lead to severe liver damage and failure.
Study Overview: Regeneron Pharmaceuticals and Sanofi are conducting a study titled A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis. The study aims to assess the safety, tolerability, and effectiveness of dupilumab in treating eosinophilic esophagitis (EoE) in small children, a condition that affects feeding and nourishment.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 study titled A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH). The study aims to evaluate the effectiveness and safety of two experimental drugs, REGN9933 and REGN7508, in preventing venous thromboembolism (VTE) in adults with a peripherally inserted central catheter (PICC).
Regeneron Pharmaceuticals is conducting a study titled A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction. The study aims to assess the safety, tolerability, and effectiveness of REGN5381 in patients with heart failure, focusing on side effects, drug levels in the blood, and antibody development against the drug.
Regeneron Pharmaceuticals and Sanofi are conducting an observational study titled A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care. The study aims to understand the real-world application of DUPIXENT® (dupilumab) in treating patients with eosinophilic esophagitis (EoE), focusing on patient experiences and outcomes.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)’. The study aims to assess the efficacy of REGN7508 in preventing venous thromboembolism (VTE) in adults undergoing total knee replacement surgery, along with evaluating potential side effects, drug levels in the blood, and antibody development against the drug.
Regeneron Pharmaceuticals is conducting a clinical study titled A Phase 2, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Subcutaneously Administered REGN7999 (an Inhibitor of TMPRSS6) in Participants with Iron Overload Due to Non-Transfusion Dependent β-Thalassemia. The study aims to assess the safety and effectiveness of REGN7999 in reducing iron overload in patients with non-transfusion dependent beta-thalassemia, using MRI scans to measure iron levels.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 study titled A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients With Sepsis-Induced Hypotension. The study aims to evaluate the safety, tolerability, and effectiveness of REGN7544 in treating adult patients with sepsis-induced hypotension, focusing on its impact on blood pressure and vasopressor dosage.
Regeneron Pharmaceuticals is conducting a Phase 1b clinical study titled ‘Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma.’ The study aims to evaluate the safety and optimal dosage of linvoseltamab when combined with other cancer treatments for patients with multiple myeloma that is resistant to standard therapies. This research is significant as it explores new treatment combinations for a challenging condition.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 study titled ‘Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer.’ The study aims to evaluate the safety, tolerability, and effectiveness of ubamatamab, alone and in combination with other anti-cancer drugs, in patients with advanced ovarian cancer. This research could provide significant insights into new treatment options for this challenging condition.
Regeneron Pharmaceuticals is conducting a study titled A Randomized, Open-Label, C5 Inhibitor-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy. The study aims to assess the safety and effectiveness of the pozelimab and cemdisiran combination in treating Paroxysmal Nocturnal Hemoglobinuria (PNH) compared to existing treatments ravulizumab and eculizumab.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)’. The study aims to evaluate the safety, tolerability, and efficacy of odronextamab combined with chemotherapy compared to the standard treatment of rituximab with chemotherapy in patients with follicular lymphoma, a type of non-Hodgkin lymphoma.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 3 randomized study titled ‘A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC).’ The study aims to evaluate the efficacy of cemiplimab, an immune-boosting drug, compared to standard surgical treatment for early-stage CSCC. This research is significant as it explores a less invasive treatment option that could potentially improve patient outcomes.
Regeneron Pharmaceuticals is currently conducting a Phase 3 clinical study titled ‘A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration.’ The study aims to evaluate the progression rate of Geographic Atrophy in patients treated with cemdisiran alone or in combination with pozelimab compared to a placebo, with a focus on safety, drug levels in the blood, and potential antibody development.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 trial titled A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC. The study aims to evaluate the safety and efficacy of combining fianlimab, cemiplimab, and chemotherapy compared to cemiplimab and chemotherapy alone in treating resectable non-small cell lung cancer (NSCLC). This research is significant as it explores potential improvements in peri-operative therapy for NSCLC patients.
Regeneron Pharmaceuticals is conducting a study titled A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B. The study aims to evaluate the safety and effectiveness of a novel gene insertion therapy, REGV131-LNP1265, designed to enable long-term production of clotting factor in patients with hemophilia B, potentially reducing the need for regular factor replacement therapy.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma. The study aims to evaluate the safety and efficacy of odronextamab, an experimental bispecific antibody, combined with lenalidomide, compared to the current standard treatment of rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. This research is significant as it explores a potentially more effective treatment option for these lymphoma subtypes.
Regeneron Pharmaceuticals is conducting a real-world evidence study titled Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry. The study aims to estimate the incidence of retinal vasculitis (RV) events in patients receiving aflibercept intravitreal (IVT) therapy, commonly known as Eylea® 2mg, in US clinical practice. This research is significant as it seeks to confirm RV cases identified through ICD-10-CM codes and identify RV with occlusion.
Study Overview: The clinical study titled A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis aims to evaluate the pharmacokinetics and safety of Dupilumab in young participants suffering from Prurigo Nodularis. This study is significant as it targets a pediatric population, potentially expanding treatment options for this chronic skin condition.
Study Overview: Regeneron Pharmaceuticals is conducting a study titled An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria. The study aims to assess the long-term safety and effectiveness of the pozelimab and cemdisiran combination therapy in treating Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare blood disorder. This research is significant as it explores potential new treatment options for PNH patients.
Regeneron Pharmaceuticals and Sanofi are conducting a clinical study titled A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis. The study aims to evaluate the pharmacokinetics and safety of Dupilumab in young participants suffering from Prurigo Nodularis, a chronic skin condition. This research is significant as it could lead to new treatment options for a demographic that currently has limited therapeutic choices.
Study Overview: Regeneron Pharmaceuticals and Intellia Therapeutics are conducting a study titled A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B. The study aims to evaluate the safety and effectiveness of a gene insertion therapy for individuals with hemophilia B, a condition caused by a genetic mutation in the coagulation Factor 9 gene. The primary goal is to determine a safe and well-tolerated dose of the therapy, with secondary objectives including the assessment of drug presence in the blood, antibody formation, and the impact on quality of life and joint health.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)’. The study aims to determine if the combination of odronextamab and lenalidomide is more effective and safer than the current standard treatment of rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Study Overview: Regeneron Pharmaceuticals is conducting a study titled Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry. The study aims to estimate the incidence of retinal vasculitis (RV) among adult patients receiving aflibercept 2 mg in the United States. This research is significant as it seeks to provide real-world insights into the safety profile of aflibercept, a drug widely used in ophthalmology.
The recent clinical study update from Regeneron Pharmaceuticals and Sanofi focuses on the investigation of Itepekimab, an anti-IL-33 monoclonal antibody, to understand its effects on airway inflammation in patients with Chronic Obstructive Pulmonary Disease (COPD). Officially titled ‘A Phase 2a, Open-label, Two-part Study to Evaluate the Mechanism of Action of Itepekimab (Anti-IL-33 mAb) on Airway Inflammation in Patients With Chronic Obstructive Pulmonary Disease (COPD)’, the study aims to explore the drug’s mechanism in former and current smokers with COPD, highlighting its significance in potentially advancing COPD treatment options.
Study Overview: Regeneron Pharmaceuticals is conducting a study titled An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria. The study aims to assess the long-term safety and effectiveness of a combination therapy using pozelimab and cemdisiran in treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
Study Overview: The clinical study titled A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis aims to evaluate the pharmacokinetics and safety of Dupilumab in young patients with Prurigo Nodularis. This study is significant as it addresses a pediatric population for a condition that lacks extensive treatment options.
The recently completed clinical study titled ‘Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab’ aimed to demonstrate the efficacy of dupilumab in treating chronic spontaneous urticaria (CSU) in patients who remain symptomatic despite H1 antihistamine use. The study’s significance lies in its potential to offer a new treatment option for CSU patients who do not respond adequately to existing therapies.
Regeneron Pharmaceuticals is conducting a study titled ‘An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria.’ The study aims to assess the long-term safety and effectiveness of the pozelimab and cemdisiran combination in treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. This research is significant as it explores potential new treatments for PNH, focusing on safety, efficacy, and the body’s response to the drugs.
Regeneron Pharmaceuticals and Intellia Therapeutics are conducting a study titled A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B. The study aims to evaluate the safety and effectiveness of a gene insertion therapy for hemophilia B, focusing on finding a safe and well-tolerated dose while assessing various health impacts on participants.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 3 randomized study titled ‘A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)’. The study aims to evaluate the efficacy of cemiplimab, an immune-boosting drug, compared to traditional surgery in treating early-stage CSCC, a common form of skin cancer. This research is significant as it explores a potentially less invasive treatment option for patients.
Regeneron Pharmaceuticals, in collaboration with Sensei Biotherapeutics, is conducting a Phase 1/2 study titled A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors. The study aims to assess the safety and efficacy of SNS-101, a novel anti-VISTA IgG1 monoclonal antibody, both as a standalone treatment and in combination with cemiplimab for patients with advanced solid tumors.
Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)’. The study aims to evaluate the safety and effectiveness of garetosmab, an experimental drug, in treating FOP, a rare and debilitating condition. The study also investigates potential side effects, drug levels in the blood, and the body’s immune response to the drug.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 clinical trial titled A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH). The study aims to evaluate the effectiveness and safety of two experimental drugs, REGN9933 and REGN7508, in preventing venous thromboembolism (VTE) in adults with a peripherally inserted central catheter (PICC). The study also explores potential side effects and the body’s antibody response to the drugs.
Regeneron Pharmaceuticals and Intellia Therapeutics have launched a Phase 3 clinical study titled ‘MAGNITUDE-2’ to assess the efficacy and safety of NTLA-2001 in treating hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This study is crucial as it explores a potential breakthrough treatment for a debilitating genetic disorder.
Regeneron Pharmaceuticals is conducting a clinical study titled ‘Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer.’ The study aims to evaluate the safety, tolerability, and effectiveness of ubamatamab, both alone and in combination with other anti-cancer drugs, in patients with advanced ovarian cancer. This research is significant as it targets platinum-resistant ovarian cancer, a challenging condition to treat.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 1/2 clinical trial titled A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors. The study aims to evaluate the safety, tolerability, and optimal dosing of REGN7075 alone and in combination with cemiplimab, with or without chemotherapy, in patients with advanced solid tumors. The significance lies in potentially offering new treatment avenues for difficult-to-treat cancers.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC).’ The study aims to evaluate the effectiveness of cemiplimab, an immunotherapy drug, compared to standard surgical treatment for early-stage CSCC. This research is significant as it explores a less invasive treatment option that could enhance patient outcomes and potentially reduce recovery times.
Regeneron Pharmaceuticals and Intellia Therapeutics are conducting a study titled A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B. The study aims to evaluate the safety and effectiveness of a gene insertion therapy for individuals with hemophilia B, focusing on finding a safe dose and assessing the therapy’s impact on quality of life, joint health, and the need for factor replacement therapy.
Regeneron Pharmaceuticals and Sanofi are conducting a study titled A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma. The study aims to evaluate the effectiveness of Dupilumab in preventing or slowing lung function decline in adults with uncontrolled moderate to severe asthma, highlighting its potential significance in improving patient outcomes.
Regeneron Pharmaceuticals and Sanofi are conducting a Phase 2 clinical trial titled ‘A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype.’ The study aims to evaluate the effectiveness and safety of Dupilumab in treating ulcerative colitis with an eosinophilic phenotype, a condition that significantly impacts patients’ quality of life.
Study Overview: Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma.’ The study aims to evaluate the safety and effectiveness of the experimental combination of fianlimab and cemiplimab compared to the approved combination of relatlimab and nivolumab in treating advanced melanoma.
Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4).’ The study aims to assess the safety, tolerability, and efficacy of odronextamab in patients with aggressive B-cell non-Hodgkin lymphoma that has relapsed or is refractory.
Regeneron Pharmaceuticals, in collaboration with Servier Bio-Innovation LLC and Institut de Recherches Internationales Servier, is conducting a Phase 1b/2 study titled A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression. The study aims to evaluate the safety and efficacy of the anti-PD1 antibody, cemiplimab, in combination with other antibodies (S095018, S095024, or S095029) in patients with advanced NSCLC.
Study Overview: Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 clinical trial titled A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. The study aims to assess the effectiveness, safety, and tolerability of Itepekimab, an anti-IL-33 monoclonal antibody, as an add-on therapy for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The clinical study titled A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze aims to evaluate the effectiveness and safety of Dupilumab in young children. This study is significant as it addresses the need for effective treatments in this vulnerable age group with uncontrolled asthma.
Regeneron Pharmaceuticals and Sanofi are conducting a study titled ‘A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care.’ The study aims to understand the use of DUPIXENT® (dupilumab) in treating eosinophilic esophagitis (EoE) and its impact on patients’ quality of life and symptoms. This research is significant as it could inform future treatment decisions and clinical trial designs for EoE.
Regeneron Pharmaceuticals is conducting a groundbreaking study titled ‘First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ALN-SOD in Participants With Amyotrophic Lateral Sclerosis and SOD1 Mutations.’ The study aims to assess the safety and tolerability of ALN-SOD, an experimental drug for ALS patients with SOD1 gene mutations, marking its first human trial.
Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 clinical study titled ‘A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 1).’ The study aims to evaluate the efficacy and safety of Dupilumab in treating pruritus associated with Lichen Simplex Chronicus (LSC) in adults, highlighting its potential significance in addressing this chronic skin condition.
Regeneron Pharmaceuticals is conducting a Phase 1 study titled ‘A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)’. The study aims to evaluate the safety and tolerability of cemiplimab, an experimental drug, in patients with CSCC or BCC. This research is significant as it explores potential new treatments for these skin cancers.
Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 study titled A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. The study aims to evaluate the efficacy, safety, and tolerability of Itepekimab, an anti-IL-33 monoclonal antibody, in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 study titled ‘A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Dupilumab for the Treatment of Pruritus of Lichen Simplex Chronicus (LSC) in Adults.’ The study aims to evaluate the effectiveness of Dupilumab injections in reducing pruritus in adults with LSC, compared to a placebo. This research is significant as it explores a potential new treatment for a condition that currently has limited options.
Regeneron Pharmaceuticals is involved in a Phase 1b/2 clinical study titled ‘A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression.’ The study aims to evaluate the safety and efficacy of the anti-PD1 antibody, cemiplimab, in combination with other antibodies in treating advanced NSCLC with high PD-L1 expression.
Regeneron Pharmaceuticals, Inc. is a biotechnology company that develops and commercializes medicines for serious diseases, with a focus on eye diseases, allergic and inflammatory diseases, cancer, and other conditions. The company is known for its innovative approach to drug development, utilizing proprietary technologies to create life-transforming treatments.
Regeneron Pharmaceuticals’ recent earnings call reflected a balanced sentiment, highlighting both achievements and challenges. The company reported strong sales growth for Dupixent and Libtayo, alongside promising pipeline advancements. However, hurdles such as a decline in EYLEA sales and regulatory delays due to FDA inspections were also discussed.
Regeneron Pharmaceuticals is conducting a study titled ‘A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors.’ The study aims to evaluate the effectiveness of a new drug, ALN-HSD, in reducing liver scarring in patients with MASH, a severe liver condition linked to genetic factors.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)’. The study aims to evaluate the safety, tolerability, and efficacy of odronextamab combined with chemotherapy compared to the current standard treatment of rituximab with chemotherapy in patients with follicular lymphoma.
The clinical study titled ‘PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting’ aims to evaluate the characteristics and treatment patterns of asthma patients using Dupilumab (DUPIXENT). The study’s primary objective is to characterize patients’ medical history, socio-demographic data, and treatment history. It also seeks to assess the effectiveness and safety of Dupilumab in real-world settings, making it significant for understanding its practical application and impact on asthma management.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5). The study aims to evaluate the safety and efficacy of the experimental drug odronextamab combined with lenalidomide compared to the standard treatment of rituximab and lenalidomide in treating relapsed or refractory follicular lymphoma and marginal zone lymphoma.
Regeneron Pharmaceuticals is conducting a Phase 2 clinical trial titled A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC. The study aims to evaluate the safety and efficacy of combining fianlimab with cemiplimab and chemotherapy compared to cemiplimab and chemotherapy alone in treating non-small cell lung cancer (NSCLC) that can be surgically removed.
Regeneron Pharmaceuticals and Sanofi are collaborating on a Phase 4 clinical study titled ‘A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.’ The study aims to assess the impact of Dupilumab on airway inflammation, lung function, and quality of life in patients aged 40 to 85 with COPD.
Regeneron Pharmaceuticals is conducting a Phase 1b study titled ‘Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma.’ The study aims to evaluate the safety and appropriate dosing of linvoseltamab, an experimental drug, when combined with other cancer treatments for multiple myeloma patients who are resistant to standard care.
Regeneron Pharmaceuticals is conducting a clinical study titled ‘A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody.’ The study aims to evaluate the safety and tolerability of mibavademab, an experimental drug, in patients with Generalized Lipodystrophy (GLD) who have been on metreleptin treatment for at least six months. The significance of this study lies in its potential to offer a new treatment option for GLD patients.
Regeneron Pharmaceuticals is conducting a Phase 2 clinical study titled A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction. The study aims to assess the safety, tolerability, and effectiveness of REGN5381 in patients with heart failure, focusing on potential side effects and the body’s response to the drug.
Regeneron Pharmaceuticals has completed a Phase 1 clinical study titled A Three-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-PNP siRNA in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a PNPLA3 Genetic Risk Factor. The study aimed to assess the safety, tolerability, and effectiveness of ALN-PNP in adults with NAFLD and a specific genetic risk factor.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)’. The study aims to evaluate the safety and efficacy of odronextamab combined with lenalidomide compared to the current standard treatment of rituximab with lenalidomide in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma.
Regeneron Pharmaceuticals is conducting a Phase 2 clinical study titled ‘A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors.’ The study aims to evaluate the effectiveness of a gene-silencing drug, ALN-HSD, in reducing liver scarring in patients with MASH, a serious liver condition that can lead to cirrhosis and liver failure.
Regeneron Pharmaceuticals is conducting a Phase 3 clinical trial titled ‘A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)’. The study aims to evaluate the safety, tolerability, and efficacy of odronextamab combined with chemotherapy compared to the standard treatment of rituximab with chemotherapy in adults with follicular lymphoma.
Regeneron Pharmaceuticals and Intellia Therapeutics are conducting a Phase 3 clinical study titled ‘MAGNITUDE-2’ to evaluate the efficacy and safety of NTLA-2001 in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This study aims to assess the impact of a single dose of NTLA-2001 compared to a placebo, highlighting its potential significance in treating this rare genetic disorder.
Regeneron Pharmaceuticals and Sanofi are conducting a study titled ‘PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting.’ The study aims to understand the characteristics of asthma patients treated with Dupixent, focusing on their medical history, treatment patterns, and effectiveness of the drug in real-world settings. This research holds significance for improving asthma treatment strategies and patient outcomes.
The recent clinical study titled ‘MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)’ aims to evaluate the efficacy and safety of NTLA-2001. This study is significant as it targets ATTR-CM, a condition with limited treatment options, potentially offering a new therapeutic pathway.
Study Overview: Regeneron Pharmaceuticals and Sanofi are collaborating on a clinical study titled A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease. The study aims to assess the impact of Dupilumab on airway inflammation and lung function in patients aged 40 to 85 with COPD, highlighting its potential to improve quality of life.