Pozelimab

FOP is an ultra-rare genetic disorder characterized by abnormal bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disability If approved, garetosmab would be the first and only available treatment shown to reduce the number and volume of new heterotopic bone lesions in adults with FOP TARRYTOWN, N.Y., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva (FOP). Garetosmab is a monoclonal antibody that blocks Activin A, a protein that Regeneron scientists discovered to be critical in the development of heterotopic ossification (HO) lesions in people with FOP. The target action date for the FDA decision is August 2026. FOP is a relentless, ultra-rare genetic disorder in which muscles, tendons, ligaments and other connective tissues are progressively infiltrated by abnormal bone formation, a process known as HO, which results in significant disfunction of these structures and skeletal deformity. HO of the jaw, spine, hip and rib cage can make it difficult to speak, eat, walk or breathe, leading to weight loss and escalating loss of mobility. Most people with FOP are wheelchair bound by 30 years old, and the median age of survival is approximately 56 years. Approximately 900 people are diagnosed with FOP worldwide, with many others thought to remain undiagnosed or misdiagnosed. The BLA is supported by efficacy and safety data from the positive Phase 3 OPTIMA trial evaluating garetosmab in adults with FOP. Both garetosmab doses (3 mg/kg and 10 mg/kg) evaluated in the trial were highly efficacious in reducing the total number and volume of new HO lesions at 56 weeks, compared to placebo. Regarding the primary endpoint analysis of reduction in total number of new HO lesions compared to placebo (n=21), those receiving the 3 mg/kg dose (n=19) experienced a 94% reduction (1 lesion vs. 19 lesions; p=0.0274), while those receiving the 10 mg/kg dose (n=23) experienced a 90% reduction (2 lesions vs. 19 lesions; p=0.0260). A post-hoc analysis also found both doses of garetosmab demonstrated a greater than 99% reduction in mean total volume (cm 3 ) of new HO lesions compared to placebo (3 mg/kg: 0.01 cm 3 vs. 10.45 cm 3 ; nominal p=0.0013; 10 mg/kg: 0.02 cm 3 vs. 10.45 cm 3 ; nominal p=.0005). At 56 weeks, among all 63 people with FOP aged 18 years and older who participated in the OPTIMA trial, serious treatment-emergent adverse events occurred in 1 patient treated with 3 mg/kg garetosmab, 2 patients treated with 10 mg/kg garetosmab and 2 patients treated with placebo. The most common adverse reactions (incidence ≥30%) are epistaxis, increased hair growth, abscess and acne. Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The FDA previously granted Fast Track designation and Orphan Drug Designation for garetosmab for the prevention of HO in patients with FOP. Garetosmab has also been granted Orphan Designation in the European Union, and additional garetosmab regulatory submissions are planned in countries around the world. The safety and efficacy of garetosmab, as well as its potential use for the treatment of FOP, are investigational and have not been fully evaluated or approved by any regulatory authority. About the OPTIMA Clinical Trial OPTIMA is a Phase 3, multi-center, multinational trial to assess the efficacy of garetosmab on the reduction of heterotopic bone formation, as well as its safety, tolerability, and pharmacokinetics, in patients with active FOP. The trial enrolled 63 participants aged 18 years and older who have any FOP-causing variant of type I Activin A receptor (ACVR1), exhibited FOP disease activity or progression of HO lesions, and had a cumulative analogue joint involvement scale (CAJIS) score at screening of ≤19. CAJIS is a clinician-assessed tool, with higher scores representing greater disease severity (scale: 0 to 30). Eligible participants were randomized to intravenously receive 3 mg/kg garetosmab, 10 mg/kg garetosmab, or placebo once every four weeks for 56 weeks. Following this, participants could elect to extend their treatment for at least 84 weeks or discontinue treatment and enter an observation-only arm. During the treatment period, efficacy was evaluated through whole body computed tomography (CT) scans for HO lesions; physician and patient assessment of flare-ups; utilization of CAJIS to rate joint functionality; and observances of change in disease severity. Safety assessment includes reports of adverse events, measurement of vital signs, physical examination, and coagulation testing. A Phase 3 trial of garetosmab in adolescents and children with FOP, OPTIMA 2, is planned to begin later this year. For more information, visit the Regeneron clinical trials website, contact clinicaltrials@regeneron.com , or call +1 844-734-6643. About Garetosmab Regeneron has been engaged in FOP research for decades and helped to provide fundamental insights into the biology and natural history of the disease. Regeneron scientists discovered that Activin A plays a key role in FOP by driving HO, the main pathology of FOP . Garetosmab is a VelocImmune -derived, fully-human monoclonal antibody that binds and neutralizes Activin A, which is involved in the development of heterotopic bone in people with FOP. About Regeneron’s VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce fully optimized human antibodies. When Regeneron's Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab-dgnb), Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ® (pozelimab-bbfg). In addition, REGEN-COV ® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Garetosmab was also created using Regeneron's VelocImmune technology. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite , which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn , Instagram , Facebook or X . Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation garetosmab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as garetosmab); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as garetosmab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its LinkedIn page ( ). Contacts: Media Relations Ilana Yellen Tel: +1 914-330-9618 Ilana.Yellen@regeneron.com Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com

36 abstracts to be presented across Regeneron-invented therapies, including first-time Phase 3 presentations for two distinct investigational allergen-blocking antibodies for cat and birch allergies New Dupixent ® (dupilumab) data highlight its clinical and real-world impact across dermatological, respiratory and gastrointestinal diseases, including analyses of food allergy sensitization in children with atopic dermatitis TARRYTOWN, N.Y., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced 36 abstracts across its immunology and inflammation portfolio and pipeline will be presented at the 2026 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting being held February 27 to March 2 in Philadelphia, Pennsylvania. Highlights include the first presentations from the novel Phase 3 allergen-specific programs demonstrating the potential of a first-in-class approach to addressing burdensome ocular symptoms in adults with cat and birch allergies. New Dupixent ® (dupilumab) analyses across dermatological, respiratory and gastrointestinal diseases will also be presented in collaboration with Sanofi. “At Regeneron, we are pioneering new approaches to treating allergic diseases, and at AAAAI we will present for the first time Phase 3 data from two potentially first-in-class treatments for cat and birch allergies invented by Regeneron scientists that have the potential to change the paradigm for treatment of allergic diseases. Based on these data, we will embark on additional registration-enabling trials this year,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “We are also sharing new insights on Dupixent, another drug invented by Regeneron scientists and currently the most widely used innovative branded antibody medicine. These results highlight the potential of Dupixent to further evolve the treatment paradigms of several chronic diseases, including asthma, certain allergic fungal diseases and allergies in children with atopic dermatitis. Together, these data represent our continued commitment to translate scientific insights into therapeutic breakthroughs across immunology and inflammation.” First-in-class potential for targeted antibody treatments in cat and birch allergies in “ocular challenge” a trials Presented for the first time will be results from separate Phase 3 cat and birch allergen-challenge trials, which evaluated antibody cocktails that target the most dominant allergens—FelD1 for cat allergy and BetV1 for birch allergy. The trials assessed the ability of these therapies to reduce ocular allergic symptoms, such as ocular itch and conjunctival redness, in response to antigen challenge, as well as skin prick reactivity one week after treatment, compared to placebo. The results add to data from earlier trials demonstrating the effects of these cocktails on nasal, respiratory and skin endpoints in these patients. Additional registration-enabling trials for both programs that evaluate similar endpoints but after longer follow-up are initiating this year. The cat and birch allergy programs are part of a broader allergy pipeline, which include innovative strategies with the goal of eliminating all IgE-mediated allergies. The safety and efficacy of these investigational medicines have not been evaluated by any regulatory authority. New Dupixent insights on allergy sensitization, asthma treatment escalation and potential in AFRS The impact of early and sustained Dupixent treatment on allergy sensitization in children will be shared in two new long-term analyses from a Phase 3 open-label extension trial in children with moderate-to-severe atopic dermatitis. In the separate analyses, IgE levels for common food and environmental allergies were measured throughout the course of Dupixent treatment for up to 1.5 years. These included IgE levels for egg white, peanut, cow’s milk, wheat, dust mite, plant or fungal/bacterial allergens. In adults and adolescents with asthma, two real-world analyses will also be shared evaluating the potential of moving Dupixent earlier in the treatment paradigm. The analyses measured reduction of exacerbations and systemic corticosteroid use in patients uncontrolled on medium-dose inhaled corticosteroids (ICS), comparing the addition of Dupixent with escalating to high-dose inhaled corticosteroids or the addition of other biologics. Additionally, late-breaking data from the Phase 3 AIMS trial in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) will be presented. These data formed the basis for a supplemental Biologics License Application (sBLA) in the U.S., which is currently under Priority Review with a target action date of February 28, 2026. The safety and efficacy of Dupixent in AFRS have not been fully evaluated by any regulatory authority. The full list of Regeneron allergy presentations at AAAAI includes: Abstract Title Presentation Number Presenting Author Presentation Date and Time (ET) B cells accumulate in lung during allergic inflammation and play a role in tissue remodeling 899 Oral Abstract Session Maloney, A. Tuesday, Mar 2 12:45 - 2:00 pm Immunological evaluation of cat allergic individuals living with or without a cat 278 Atanasio, A. Friday, Feb 27 2:45 - 3:45 pm Prediction of symptomatic relief in allergic individuals using a preclinical mouse model of allergic anaphylaxis 279 Atanasio, A. Friday, Feb 27 2:45 - 3:45 pm IL4Ra blockade reduces Oral Immunotherapy outcome-related adverse events through inhibition of Mast cell activity in a murine model of oral immunotherapy 463 Atanasio, A. Saturday, Feb 28 9:45 - 10:45 am A Single Prophylactic Dose of REGN1908-1909 Significantly Suppressed Cat-Allergen Induced Allergic Conjunctivitis Signs and Symptoms and Skin Test Reactivity 746 Gagnon, R. Sunday, Mar 1 9:45 - 10:45 am Utilizing an Indirect Basophil Activation Test to Interrogate the Potency of Bet v 1 and Related Allergens 743 Maloney, K. Sunday, Mar 1 9:45 - 10:45 am Multidimensional Burden In Cat Allergic Individuals Despite Allergen Avoidance Efforts 677 Schneider, S. Sunday, Mar 1 9:45 - 10:45 am Antibody Cocktail Targeting Bet v1 Reduces Signs and Symptoms of Allergic Conjunctivitis in Birch Allergic Individuals Undergoing Conjunctival Allergen Challenge 742 Torkildsen, G. Sunday, Mar 1 9:45 - 10:45 am The full list of Regeneron and Sanofi Dupixent presentations at AAAAI includes: Abstract Title Presentation Number Presenting Author Presentation Date and Time (ET) Atopic Dermatitis Dupilumab Treatment up to 1 Year Reduces Allergen-Specific IgE in Young Children With Moderate-to-Severe Atopic Dermatitis 016 Beck, L.A. Friday, Feb 27 2:45 - 3:45 pm Progressive Reduction of Allergen-Specific IgE in Children Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis Treated With Dupilumab 015 Beck, L.A. Friday, Feb 27 2:45 - 3:45 pm Minimally Invasive Skin Tape Strip Proteomic Analysis Demonstrates Significant Inhibition of Epidermal Hyperplasia Protein Cluster in Pediatric Atopic Dermatitis Patients Treated With Dupilumab 053 Goleva, E. Friday, Feb 27 2:45 - 3:45 pm Systemic Treatments Outcomes for Moderate-to-Severe Atopic Dermatitis in Children Aged Less Than 12 Years: PEDISTAD 5-Year Results 052 Leung, D.Y.M. Friday, Feb 27 2:45 - 3:45 pm Asthma Dupilumab With Medium-Dose Inhaled Corticosteroids Versus Omalizumab With High-Dose Inhaled Corticosteroids Improves Clinical Outcomes In Patients With Coexisting Chronic Rhinosinusitis With Nasal Polyps And Uncontrolled Asthma L03 Wagenmann, M. Saturday, Feb 28 9:45-10:45am Baseline Predictors of Clinical Remission in Children With Uncontrolled, Moderate-To-Severe Asthma Treated With Dupilumab: A Post Hoc Analysis of the VOYAGE Study 130 Bacharier, L.B. Friday, Feb 27 2:45 - 3:45 pm Dupilumab Improves Lung Function and Reduces Total and Specific IgE Levels in Patients With Asthma and Allergic Bronchopulmonary Aspergillosis: The Phase 2 LIBERTY ABPA AIRED Study 828 Corren, J. Sunday, Mar 1 3:30 - 5:00 pm Systemic Corticosteroid Use Before Biologic Initiation Among Pediatric Patients With Asthma in the United States 138 Guilbert, T.W. Friday, Feb 27 2:45 - 3:45 pm Systemic Corticosteroid Use Among Pediatric Patients With Uncontrolled Moderate-to-Severe Asthma in the United States 119 Jackson, D.J. Friday, Feb 27 2:45 - 3:45 pm Escalation to High-Dose ICS Versus Dupilumab Initiation in Uncontrolled Asthma Patients on Medium-Dose ICS: A Matched Analysis of Administrative Claims 125 Katial, R. Friday, Feb 27 2:45 - 3:45 pm Utility of Spirometry-Derived Ratios to Detect Changes in Large and Small Airways With Dupilumab in Moderate-to-Severe Asthma 643 Lipworth, B. Sunday, Mar 1 9:45 - 10:45 am Real-World Outcomes Following Asthma Treatment Escalation From Medium-Dose ICS to high-Dose ICS or Biologics 133 Lugogo, N.L. Friday, Feb 27 2:45 - 3:45 pm Patient-Reported Burden of Coexisting Type 2 Inflammatory Conditions in Patients Initiating Dupilumab for Asthma: Baseline Data From the REVEAL Registry 634 Maspero, J.F. Sunday, Mar 1 9:45 - 10:45 am Improved Quality of Life Over 1 Year in Patients With Asthma who Initiate Dupilumab in a Real-World Clinical Setting: The RAPID Registry 143 Peters, A.T. Friday, Feb 27 2:45 - 3:45 pm Children With Asthma Receiving Dupilumab had Reduced Exacerbations and Improved Asthma Control Versus Placebo, Regardless of Asthma Duration 118 Phipatanakul, W. Friday, Feb 27 2:45 - 3:45 pm CRSwNP Dupilumab for Treatment of Allergic Fungal Rhinosinusitis in Adults and Children Aged 6 and Over: Results From LIBERTY-AIMS Study L40 Late Breaking Poster Presentation Han, J. Sunday, Mar 1 9:45 - 10:45 am Comparative Efficacy of Dupilumab and Tezepelumab in Patients With Chronic Rhinosinusitis With Nasal Polyps: An Anchored Matching-adjusted Indirect Comparison L78 Late Breaking Poster Presentation Lipworth, B. Sunday, Mar 1 9:45 - 10:45 am Dupilumab Led to Rapid Improvements in Nasal Congestion and Loss of Smell in Patients With Chronic Rhinosinusitis With Nasal Polyps: Results from the Global AROMA Registry 244 Buchheit, K. Friday, Feb 27 2:45 - 3:45 pm Efficacy of Dupilumab vs Omalizumab in Patients With Severe Chronic Rhinosinusitis With Nasal Polyps Coexisting With Asthma and Allergic Rhinitis: Results From the Head-to-Head, Prospective, Randomized EVEREST study 241 Oppenheimer, J. Friday, Feb 27 2:45 - 3:45 pm Dupilumab Improved Work Productivity in Patients With CRSwNP: Results From the Global AROMA Registry 237 Peters, A.T. Friday, Feb 27 2:45 - 3:45 pm Concurrent Improvement in Nasal Polyp Score and Forced Expiratory Volume in One Second With Dupilumab vs Omalizumab in Patients With Severe CRSwNP and Coexisting Asthma: Results From the EVEREST Study 238 Peters, A.T. Friday, Feb 27 2:45 - 3:45 pm Real-World Dupilumab Effectiveness Through 18 Months in Patients With CRSwNP and Coexisting Allergic Rhinitis: Results From the Global AROMA Registry 245 White, A. Friday, Feb 27 2:45 - 3:45 pm COPD Evaluating Fractional Exhaled Nitric Oxide as a Predictor of Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease With Type 2 Inflammation 652 Soliman, M. Sunday, Mar 1 9:45 - 10:45 am EoE Dupilumab Leads to Sustained Treatment Response up to 52 Weeks in Dysphagia and Odynophagia Associated With Eosinophilic Esophagitis in Adults and Adolescents: Post-Hoc Analysis of the LIBERTY EoE TREET Study 180 Cianferoni, A. Friday, Feb 27 2:45 - 3:45 pm Dupilumab Maintains Histologic and Endoscopic Improvements Across Age Subgroups in Pediatric Patients With Eosinophilic Esophagitis (EoE) Over 52 Weeks: Pooled Analysis From Two Phase 3 Studies (EoE KIDS and LIBERTY EoE TREET) 172 McGown, E. Friday, Feb 27 2:45 - 3:45 pm CSU Dupilumab Reduced Itch and Urticaria Activity in Chronic Spontaneous Urticaria Patient Subpopulations 001 Casale, T.B. Friday, Feb 27 2:45 - 3:45 pm Dupilumab Efficacy in Pooled LIBERTY-CSU CUPID Study A and Study C Regardless of Baseline Serum Total IgE Levels 023 Saini, S.S. Friday, Feb 27 2:45 - 3:45 pm Cross-Franchise Serum Total IgE Reductions With Dupilumab Treatment in Pediatric Patients With Atopic Dermatitis, Asthma or Eosinophilic Esophagitis and their Relationship to Clinical Improvement 014 Beck, L.A. Friday, Feb 27 2:45 - 3:45 pm About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab-dgnb), Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ® (pozelimab-bbfg). In addition, REGEN-COV ® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. U.S. INDICATIONS DUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with AD under 6 months of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age. to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg). to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age. with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age. to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg). to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age. DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria). IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT ® . Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to . are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have AD, CRSwNP, EoE, PN, COPD, CSU, or BP and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area. Eye pr ob l e m s. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed. I n fl a mm a t i o n o f y ou r b l oo d v e ss e l s. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs. Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. The most common side effects include: Eczema: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). A s t h ma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections. Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision, high count of a certain white blood cell (eosinophilia), stomach problems (gastritis), joint pain (arthralgia), trouble sleeping (insomnia), and toothache. Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia). Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea. Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, stomach problems (gastritis), joint pain (arthralgia), toothache, headache, and urinary tract infection. Chronic Spontaneous Urticaria: injection site reactions. Bullous Pemphigoid: joint pain (arthralgia), eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, and herpes virus infections. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. P l ea se s e e a cc o mp any i n g f u l l P r e s cri b i n g I n f o r ma t i o n i nc l ud i n g P a t i en t I n f o r ma t i o n. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn , Instagram , Facebook or X . Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent ® (dupilumab) for the treatment of allergic fungal rhinosinusitis and other potential indications, Regeneron’s investigational allergen-blocking antibody combination therapies for the treatment of cat and birch allergies, and Regeneron’s broader allergy pipeline discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including those referenced above; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above ) ; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including the research programs discussed or referenced in this press release, such as those evaluating Dupixent for food and environmental allergies and expanded use in asthma ) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA ® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its LinkedIn page ( ). Regeneron Contacts: Media Relations Hannah Kwagh Tel: +1 914-847-6314 Hannah.Kwagh@regeneron.com Ilana Yellen Tel: +1 914-330-9618 Ilana.Yellen@regeneron.com Kailey Kilmartin Tel: +1 914-652-0679 Kailey.Kilmartin@regeneron.com Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com a The conjunctival allergen challenge was conducted with the Ora Conjunctival Challenge Model (Ora-CAC ® ) .