reports
Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medici...
Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP) Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating and relapsing rare skin disease affecting approximately 27,000 adults in the U.S. whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the U.S. to treat eight distinct diseases with underlying type 2 inflammation, including diseases of t...
Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizuma...
Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4 Head-to-Head Respiratory Trial New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoints Dupixent also outperformed Xolair in improving such key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and lung function and disease control in asthma, with rapid improvements seen as ...
Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) ...
Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color Atopic dermatitis is a chronic disease that disproportionately impacts communities of color Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients Patients experienced substantial reductions in hyperpigmentation, dry skin and itch from baseline Results support commitment to enhance clinical understanding of chronic diseases in communities of color TARRYTOWN,...
Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-L...
Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist New licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist in advanced stages of clinical development in China Phase 2 data suggest potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist Key complementary asset enables synergy and flexibility across Regeneron’s broad pipeline of obesity and metabolic programs focused on improved quality of weight loss, co-morbidities and long-term health TARRYTOWN,...
Interim Results from Ongoing Phase 2 COURAGE Trial Confirm Potential t...
Interim Results from Ongoing Phase 2 COURAGE Trial Confirm Potential to Improve the Quality of Semaglutide (GLP-1 receptor agonist)-induced Weight Loss by Preserving Lean Mass Trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass Combining semaglutide with muscle-preserving antibodies protected lean mass – sparing approximately 50%-80% of the lean mass lost with semaglutide alone – while also increasing loss of fat mass TARRYTOWN, N.Y., June 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced int...
Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-S...
Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p
Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulm...
Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials AERIFY-1 trial met the primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit AERIFY-2, a second Phase 3 trial, did not meet the primary endpoint despite a benefit seen earlier in the trial Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2, with safety consistent with prior clinical trials Regeneron and Sanofi are a...
Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Prom...
Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma First results to be presented in two ASCO oral presentations Data in both combinations demonstrate high response rates TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with...
Regeneron Enters into Asset Purchase Agreement to Acquire 23andMe® for...
Regeneron Enters into Asset Purchase Agreement to Acquire 23andMe® for $256 Million; Plans to Maintain Consumer Genetics Business and Advance Shared Goals of Improving Human Health and Wellness Purchase is subject to bankruptcy court and regulatory approvals Regeneron will prioritize the privacy, security and ethical use of 23andMe’s customer data; stands ready to work with independent, court-appointed Customer Privacy Ombudsman Planned purchase to strengthen Regeneron’s ongoing leadership in genetics-guided research and drug development to help people with serious diseases TARRYTOWN, N....
75th Annual Regeneron International Science and Engineering Fair Award...
75th Annual Regeneron International Science and Engineering Fair Awards Teen Scientists from Around the World More Than $9 Million in 2025 Competition , 19, receives $100,000 Top Award for his development of a medicine that can stop viruses from copying genes and controlling infections at the world’s largest pre-college STEM competition in Columbus, Ohio TARRYTOWN, N.Y. and WASHINGTON, May 16, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that , 19, of Dulovce, Slovakia, won the $100,000 George D. Yancopoulos Innov...
Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Bi...
Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Biotech Innovation and Patient Access to Life-Saving Treatments Federal court jury found Amgen liable for violating antitrust and tort laws by using cross-therapeutic bundled rebates to prevent Praluent® (alirocumab) from competing in the market Jury awarded Regeneron $135.6 million dollars of compensatory damages and $271.2 million dollars in punitive damages TARRYTOWN, N.Y., May 15, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) applauds the jury verdict in the U.S. District Court for the...
Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo®...
Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo® (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination 18 presentations across five cancer types include new insights on the potential of checkpoint inhibitors and bispecific antibodies TARRYTOWN, N.Y., May 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to Jun...
Dupixent® (dupilumab) Data Presented at ATS Reinforce Impact of Target...
Dupixent® (dupilumab) Data Presented at ATS Reinforce Impact of Targeting Key Type 2 Inflammation Drivers to Improve Outcomes for Chronic Respiratory Diseases 24 abstracts, including 1 oral presentation and 4 late-breaking posters on Dupixent, to showcase new clinical and real-world analyses in chronic obstructive pulmonary disease (COPD) and asthma COPD data from the landmark Phase 3 trials will highlight Dupixent impact on lung function and health-related quality of life across broad populations of patients with type 2 inflammation Asthma abstracts include late-breaking data on mucus b...
Regeneron Reports First Quarter 2025 Financial and Operating Results
Regeneron Reports First Quarter 2025 Financial and Operating Results First quarter 2025 revenues of $3.0 billion; GAAP diluted EPS of $7.27 and non-GAAP diluted EPS(a) of $8.22First quarter 2025 Dupixent® global net sales (recorded by Sanofi) increased 19% to $3.67 billion versus first quarter 2024First quarter 2025 EYLEA HD® U.S. net sales increased 54% to $307 million versus first quarter 2024; total EYLEA HD and EYLEA® U.S. net sales decreased 26% to $1.04 billion Dupixent approved for chronic spontaneous urticaria (CSU) in U.S.; approved for chronic obstructive pulmonary disease (COPD) ...
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Trea...
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat ...
EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce...
EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Continued Safety and Efficacy and Highlight Early Real-World Outcomes for Patients with Serious Retinal Disease Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice New indirect comparisons will evaluate EYLEA HD and faricimab on measures of efficacy, dosing frequency and potential economic benefits in patients with wet age-related macular degeneration and diabetic macular edema TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSW...
Regeneron Announces New Investment in Manufacturing of its Industry-Le...
Regeneron Announces New Investment in Manufacturing of its Industry-Leading Biologic Medicines New manufacturing and supply agreement with FUJIFILM Diosynth Biotechnologies in North Carolina will enable additional production of Regeneron’s biologic medicines and support high-paying jobs in the region Regeneron’s ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expected to total more than $7 billion TARRYTOWN, N.Y., April 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a significant exp...
Regeneron Announces Investor Conference Presentations
Regeneron Announces Investor Conference Presentations TARRYTOWN, N.Y., April 21, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: BofA Securities 2025 Health Care Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 13, 20252025 RBC Capital Markets Global Healthcare Conference at 11:00 a.m. ET on Tuesday, May 20, 2025Bernstein 41st Annual Strategic Decisions Conference at 11:00 a.m. ET on Wednesday, May 28, 2025Goldman Sachs 46th Annual Global Healthcare Conference at 10:40 a.m. ET on Monday, June 9, 2025 The...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Su...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted T...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU) Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals...
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