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07.12.2025
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Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment
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All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time...
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25.11.2025
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Dupixent® (dupilumab) Approved as the First Targeted Medicine in the European Union (EU) in Over a Decade for Chronic Spontaneous Urticaria (CSU)
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Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo...
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19.11.2025
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EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications
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First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period...
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20.10.2025
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13.11.2025
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Regeneron Highlights Progress at American Society of Hematology (ASH), with Updated Data in Multiple Myeloma, Lymphoma and Paroxysmal Nocturnal Hemoglobinuria Programs
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Oral presentation of Lynozyfic™ (linvoseltamab-gcpt) data in newly diagnosed multiple myeloma from LINKER-MM4, the first trial to evaluate a BCMAxCD3 bispecific antibody as a monotherapy in this setting...
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08.11.2025
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Phase 2 Trials Demonstrating Antithrombotic Effect of Two Novel Regeneron Factor XI Antibodies Presented at American Heart Association Scientific Sessions and Published in The Lancet
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Proof-of-concept trials confirm robust anti-clotting effects for Regeneron’s two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement...
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07.11.2025
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Dupixent® (dupilumab) Pivotal Trial Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis (AFRS); sBLA Accepted for FDA Priority Review
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Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years and older compared to placebo...
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03.11.2025
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Regeneron Announces Investor Conference Presentations
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TARRYTOWN, N.Y., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows:...
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31.10.2025
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Dupixent® (dupilumab) Wins Prestigious 2025 Prix Galien USA Best Biotechnology Product Award
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Award recognizes the groundbreaking science of Dupixent and its transformational impact on multiple rare and common allergic and atopic conditions ...
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28.10.2025
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Regeneron Reports Third Quarter 2025 Financial and Operating Results
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TARRYTOWN, N.Y., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the third quarter of 2025 and provided a business update....
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17.10.2025
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Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
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Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p...
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15.10.2025
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Regeneron Showcases Advances Across Oncology Portfolio and Pipeline at ESMO, Highlighting Novel and Patient-Focused Approach for Difficult-to-Treat Cancers
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New safety and pharmacokinetic data from Phase 3 C-POST trial provide insights on an every 6-week dosing regimen of adjuvant Libtayo® (cemiplimab) in high-risk cutaneous squamous cell carcinoma New safety and pharmacokinetic data from Phase 3 C-POST trial provide insights on an every 6-week dosing regimen of adjuvant Libtayo® (cemiplimab) in high-r...
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12.10.2025
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DB-OTO Results in the New England Journal of Medicine Showcase Dramatic and Sustained Improvements in Hearing and Speech Perception in Children with Profound Genetic Hearing Loss
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Nearly all participants (11 of 12) experienced clinically meaningful hearing improvements, including three who achieved normal hearing; eight with longer follow-up showed stability or continued improvement in their hearing...
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20.10.2025
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08.10.2025
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Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
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Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial ...
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30.09.2025
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Regeneron to Report Third Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on October 28, 2025
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TARRYTOWN, N.Y., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2025 financial and operating results on Tuesday, October 28, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time...
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26.09.2025
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Evkeeza® (evinacumab-dgnb) ANGPTL3 Antibody Approved in the U.S. for Children as Young as 1 Year Old with Ultra-Rare Form of High Cholesterol
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FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH)...
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22.09.2025
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Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria (CSU) Advances in EU with Positive CHMP Opinion
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Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo...
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19.09.2025
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Regeneron Donates Ebola Treatment for Use in Countries Most at Risk of Outbreaks
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Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn) was the first treatment approved by the U.S. Food and Drug Administration (FDA) for Orthoebolavirus zairense, also known as Zaire ebolavirus...
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17.09.2025
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Results from Phase 2 COURAGE Trial Demonstrating Potential to Improve Quality of GLP-1 receptor agonist-induced Weight Loss by Preserving Lean Mass, Presented at EASD
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Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss...
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09.09.2025
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Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer
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Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone...
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08.09.2025
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Regeneron Advances Allergy Pipeline with Two Positive Phase 3 Trials Evaluating First-in-Class Antibody-Blockers of Cat and Birch Allergies
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In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo...
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04.09.2025
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Regeneron Announces Updated Presentation Time for Upcoming Investor Conference
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TARRYTOWN, N.Y., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that it will now present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 7:00 a.m. ET on Monday, September 8, 2025....
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26.08.2025
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Regeneron Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis
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Cemdisiran monotherapy, dosed subcutaneously every three months, met the primary and key secondary endpoints, showing a 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score...
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20.08.2025
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EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension
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TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. This includes a Chemistry, Manufacturing and Co...
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01.08.2025
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Regeneron Reports Second Quarter 2025 Financial and Operating Results
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TARRYTOWN, N.Y., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2025 and provided a business update....
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02.07.2025
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Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma
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TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prio...
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26.06.2025
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Regeneron to Report Second Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on August 1, 2025
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TARRYTOWN, N.Y., June 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2025 financial and operating results on Friday, August 1, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time th...
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20.06.2025
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Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP)
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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...
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15.06.2025
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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
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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...
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07.06.2025
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Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color
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Atopic dermatitis is a chronic disease that disproportionately impacts communities of color...
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02.06.2025
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Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist
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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...
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31.05.2025
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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
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Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001)...
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30.05.2025
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Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials
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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...
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22.05.2025
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Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma
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First results to be presented in two ASCO oral presentations...
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19.05.2025
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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
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Purchase is subject to bankruptcy court and regulatory approvals...
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16.05.2025
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75th Annual Regeneron International Science and Engineering Fair Awards Teen Scientists from Around the World More Than $9 Million in 2025 Competition
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Adam Kovalčík, 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...
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15.05.2025
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Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Biotech Innovation and Patient Access to Life-Saving Treatments
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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...
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01.05.2025
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Dupixent® (dupilumab) Data Presented at ATS Reinforce Impact of Targeting Key Type 2 Inflammation Drivers to Improve Outcomes for Chronic Respiratory Diseases
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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...
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29.04.2025
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Regeneron Reports First Quarter 2025 Financial and Operating Results
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TARRYTOWN, N.Y., April 29, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the first quarter of 2025 and provided a business update....
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28.04.2025
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Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma
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Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma...
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© Globe Newswire
28.04.2025
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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
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Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice...
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22.04.2025
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Regeneron Announces New Investment in Manufacturing of its Industry-Leading Biologic Medicines
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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...
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18.04.2025
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Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
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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 EYL...
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18.04.2025
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Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)
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Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo...
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17.04.2025
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EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications
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If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies...
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28.03.2025
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Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD)
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Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils...
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25.03.2025
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Regeneron to Report First Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on April 29, 2025
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TARRYTOWN, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2025 financial and operating results on Tuesday, April 29, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time t...
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12.03.2025
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Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to High School Seniors for Innovative Research on Classifying Celestial Objects, Treating a Rare Muscle Disease and Solving a Long-Standing Math Problem
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$250,000 top award goes to Matteo Paz in America's longest running and most distinguished science and math competition
TARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. and Society for Science (the Society) announced that Matteo Paz, 18, of Pasadena, California, won the top award of $250,000 in the 202...
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12.03.2025
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Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to High School Seniors for Innovative Scientific Research on Classifying Objects in Space, Treating a Rare Muscle Disease and Solving a Long-Standing Math Problem
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$250,000 top award goes to Matteo Paz in America’s longest running and most distinguished science and math competition $250,000 top award goes to Matteo Paz in America’s longest running and most distinguished science and math competition...
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10.03.2025
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REGN Investors Have Opportunity to Lead Regeneron Pharmaceuticals, Inc. Securities Fraud Lawsuit with the Schall Law Firm
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The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Regeneron Pharmaceuticals, Inc. (“Regeneron” or “the Company”) (NASDAQ: REGN) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Co...
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09.03.2025
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REGN Deadline: Rosen Law Firm Urges Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) Stockholders with Losses in Excess of $100K to Contact the Firm for Information About Their Rights
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Rosen Law Firm, a global investor rights law firm, reminds investors that a shareholder filed a class action on behalf of purchasers of securities of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) between November 2, 2023 and October 30, 2024. Regeneron describes itself as a “biotechnology company that designs products for eye diseases, allergic a...
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08.03.2025
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Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD
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Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch...
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07.03.2025
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Deadline Soon: Regeneron Pharmaceuticals, Inc. (REGN) Investors Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz About Securities Fraud Lawsuit
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The Law Offices of Frank R. Cruz reminds investors of the upcoming March 10, 2025 deadline to participate as a lead plaintiff in the securities fraud class action lawsuit filed on behalf of investors who acquired Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) (NASDAQ: REGN) securities between November 2, 2023 and October 30, 2024,...
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28.02.2025
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Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
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TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refrac...
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26.02.2025
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Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
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FDA decision expected by July 30, 2025 FDA decision expected by July 30, 2025...
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24.02.2025
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Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial
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As presented at ARO, 10 of 11 children with at least one post-treatment assessment showed notable improvements in hearing...
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18.02.2025
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Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)
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If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025...
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11.02.2025
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Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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Acceptance follows resolution of third-party fill/finish manufacturing issues...
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08.02.2025
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EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting
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EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared t...
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08.02.2025
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Three-Year Results for EYLEA HD® (aflibercept) Injection 8 mg in Patients with Wet Age-related Macular Degeneration Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended Dosing Intervals
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At three years of EYLEA HD treatment, the vast majority of patients maintained visual and anatomic improvements while achieving extended dosing regimens, including those of just twice a year: 77%, 58%, 40% and 24% achieved last assigned dosing intervals of ≥3, ≥4, ≥5 and 6 months, respectively...
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© Globe Newswire
04.02.2025
REGN
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Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion
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TARRYTOWN, N.Y., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2024 and provided a business update....
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