Aflibercept

Approval in CSU for children 2 to 11 years of age is based on data from the LIBERTY-CUPID clinical trial program, including an extrapolation of efficacy data showing that Dupixent significantly reduced urticaria activity compared with placebo in adults The latest approval expands Dupixent’s indication for CSU in the EU to children as young as 2 years; Dupixent is now approved for children less than 12 years of age across four chronic diseases driven in part by type 2 inflammation TARRYTOWN, N.Y. and PARIS, April 13, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent ® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. This expands the previous approval in the EU for adults and adolescents aged 12 years and older with CSU, a chronic, inflammatory skin disease that causes sudden and debilitating hives and recurring itch. “Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Dupixent is the most widely used innovative branded antibody medicine in the world, and this fourth approval for young children with chronic diseases driven in part by type 2 inflammation brings its proven efficacy and long-term safety pro yet another vulnerable population in need.” The approval in the EU is based on data from the LIBERTY-CUPID clinical trial program. This includes an extrapolation of efficacy data in adults from two Phase 3 trials ( Study A and Study C ) complemented by pharmacokinetic, safety and efficacy data from the single-arm CUPIDKids Phase 3 trial in children aged 2 to 11 years with CSU. Study A and Study C demonstrated Dupixent significantly reduced urticaria activity (a composite of itch and hives) and individual measures of itch and hive severity compared with placebo at week 24. Dupixent also increased the percentage of patients with well-controlled disease and complete response at week 24 compared with placebo. Safety results from Study A, Study C and CUPIDKids were generally consistent with the known safety pro Dupixent in its approved dermatological indications. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis and injection site bruising or hematoma were reported in the CSU adult and adolescent trials.* The adverse event more commonly observed with Dupixent (≥5%) than placebo in Study A and Study C in adults and adolescents with CSU was COVID-19. Safety data for children aged 2 to 11 years with CSU were generally consistent with the safety pro adult and adolescent patients with CSU treated with Dupixent. “Previous treatment options for young children with chronic spontaneous urticaria left many patients with uncontrolled disease where the unpredictable appearance of itch and hives continued to disrupt their daily lives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi. “Dupixent, which inhibits signaling of IL-4 and IL-13, two of the key and central drivers of type 2 inflammation, provides a first-of-its-kind approach to addressing chronic spontaneous urticaria in young children. This approval demonstrates our commitment to extending the value of Dupixent to all who may benefit, including young children.” In the U.S., the supplemental Biologics License Application (sBLA) for Dupixent has been accepted for review in certain children aged 2 to 11 years with CSU. Dupixent is currently approved for CSU in certain adults and adolescents in many jurisdictions, including the U.S. and Japan . *Adverse reactions in adults and adolescents were pooled from Study A, Study B and Study C. Study B evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite H1AH use. About CSU CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. About the Dupixent CSU Phase 3 Trial Program The LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU in children aged 2 to 11 years includes Study A, Study C and CUPIDKids. CUPIDKids was a single arm clinical trial that assessed the safety, efficacy and pharmacokinetics of Dupixent in children aged 2 to 11 years with CSU who remained symptomatic despite the use of antihistamines. During the 24-week treatment period, Dupixent was administered at 200 mg every two or four weeks or 300 mg every four weeks, with or without an initial loading dose, based on age and weight. The primary endpoint measured the serum concentration of Dupixent over time, including C trough (lowest concentration before the next dose) at week 12 and week 24. Study A and Study C were replicate, double-blind, placebo-controlled clinical trials that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged 6 years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. During the 24-week treatment period in both trials, all patients received an initial loading dose followed by either 300 mg Dupixent every two weeks, or for pediatric patients weighing 30 kg to <60 kg, 200 mg every two weeks. In both trials, endpoints assessed at week 24 included: Change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale) the primary endpoint. Change from baseline in itch (measured by the weekly itch severity score [ISS7], 0-21 scale), the key secondary endpoint. Change from baseline in hives (measured by the weekly hive severity score [HSS7], 0-21 scale), secondary endpoint. Proportion of patients achieving well-controlled disease status (UAS7 ≤6). Proportion of patients with complete response (UAS7=0). About Dupixent Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In children aged 2 to 11 years with CSU who remain symptomatic despite H1AH treatment, Dupixent is administered based on age and weight. In children aged 2 to 5 years, Dupixent is administered at 200 mg every four weeks for patients weighing ≥5 kg to <15 kg and 300 mg every four weeks for ≥15 kg to <30 kg, without an initial loading dose. In children and adolescents aged 6 to 17 years, Dupixent is administered at 300 mg every four weeks for ≥15 kg to <30 kg,** 200 mg every two weeks for ≥30 kg to <60kg and 300mg every two weeks for ≥60 kg, after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In children aged 2 to 11 years, Dupixent should be administered by a caregiver if given at home. Dupixent, which was invented using Regeneron’s proprietary VelocImmune ® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, CSU, chronic obstructive pulmonary disease (COPD), bullous pemphigoid (BP) and allergic fungal rhinosinusitis (AFRS) in different age populations. More than 1,400,000 patients are being treated with Dupixent globally. 1 **For children and adolescents aged 6 to 17 years weighing 15 kg to <30 kg, the initial dose is 300 mg on Day 1 followed by 300 mg on Day 15. Subsequent doses are initiated four weeks after Day 15. 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, Board co-Chair, 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. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. 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. to treat adults and children 6 years of age and older with allergic fungal rhinosinusitis (AFRS), who have had surgery on their nose or sinuses in the past. It is not known if DUPIXENT is safe and effective in children with AFRS under 6 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). I M POR TA NT SAF E T Y I NF O RM ATIO N Do n o t u se if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. B e f o r e u s i n g D U P I X E N T , t e l l y ou r h ea l t h c a r e pr ov i de r a bou t a l l y ou r m edi c a l c o nd i t i on s , i nc l ud i n g i f y ou : 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. 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, BP, or AFRS 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. DUP I X E N T c a n c au se s e r i o u s si d e eff e c t s , i n cl ud i n g : All e r g i c r ea c t i on s. 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. E y e 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. T h e m o st c o m m o n s i d e effe c ts i nc l ude : 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. C h r on i c R h i no s i nu s i t i s w i th N a s a l P o ly p s: 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. Allergic Fungal Rhinosinusitis : 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. 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 . About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. 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 moderate-to-severe chronic spontaneous urticaria in children aged 2 years and above; 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 Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) 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; 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 (such as Dupixent) and Regeneron’s Product Candidates 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. 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Regeneron Contacts: Media Relations Investor Relations Kailey Kilmartin Tel: +1 914-652-0679 Kailey.Kilmartin@regeneron.com Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com Sanofi Contacts: Media Relations Investor Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com L éo Le Bourhis Tel: + 33 6 75 06 43 81 leo.lebourhis@sanofi.com Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Victor Rouault Tel: +1 617-356-4751 Victor.Rouault@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com Nina Goworek Tel: +1 908 569 7086 Nina.Goworek@sanofi.com L éa Ubaldi Tel: + 33 6 30 19 66 46 lea.ubaldi@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Ekaterina Pesheva Tel: +1 410 926 6780 ekaterina.pesheva@sanofi.com Yun Li Tel: +33 6 84 00 90 72 Yun.Li3@sanofi.com 1 Data on File

Regeneron and Telix to co-develop and co-commercialize next-generation radiopharmaceutical therapies in a 50/50 cost and profit-sharing model Collaboration combines Regeneron’s leading antibody discovery/development platforms and oncology experience with Telix’s expertise in radiopharmaceutical development and manufacturing Telix to receive $40 million USD upfront for four initial programs with optionality to co-fund commercialization and profit-share, or earn up to an aggregate of $2.1 billion USD in development and commercial milestone payments plus low double-digit royalties TARRYTOWN, N.Y. and INDIANAPOLIS and MELBOURNE, Australia, April 13, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announce a collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies. The collaboration combines Regeneron’s extensive biologics expertise, including bispecific antibody discovery, with Telix’s radiopharmaceutical development platform, global manufacturing capabilities and supply chain infrastructure. The collaboration will include multiple solid tumor targets from Regeneron’s portfolio of antibodies, generated from VelocImmune ® mice. With a shared commitment to precision oncology, the parties also plan to develop radio-diagnostics to support patient selection and treatment response assessment. “At Regeneron, we follow the science to determine the best therapeutic approach for each disease, continuously expanding our toolbox of treatment modalities – from monoclonal and bispecific antibodies to cell therapies and beyond. Targeted radiopharmaceuticals represent a rapidly emerging frontier in oncology and an exciting opportunity to bring new treatment options to patients in need,” said John Lin, M.D., Ph.D., Senior Vice President of Oncology & Antibody Technology Research at Regeneron. “Telix brings deep expertise in radiopharmaceutical development and infrastructure that complements Regeneron’s antibody technologies and oncology portfolio,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Clinical Development Unit Head, Oncology at Regeneron. “Regeneron is excited to enter the targeted radiopharmaceuticals space and explore the utility of these agents either as monotherapy or rationally combined with our immunotherapy platform, particularly in areas of high unmet patient need such as lung cancer, where our PD-1 inhibitor is a global standard of care.” “The collaboration with Regeneron reflects a highly complementary set of capabilities and a unique opportunity to explore what true ‘next gen’ biologics-based radiopharmaceuticals can potentially do for patients,” said Christian Behrenbruch, D.Phil., Managing Director and Group CEO at Telix. “We are well positioned to work toward the shared goal of advancing next generation precision radiopharmaceuticals for patients with hard-to-treat cancers.” Under the terms of the agreement, Telix will receive an upfront cash payment of $40 million USD from Regeneron for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, with Regeneron having the option to expand to include four additional programs with additional upfront payments. Telix and Regeneron will share equally in the global commercialization costs and potential profits, with Telix retaining the option to co-promote certain potential products. Should Telix opt-out of the co-funding model for a particular program, it is instead eligible to receive up to $535 million USD in development and commercial milestones, plus low double-digit royalites on future net sales, for that program. Telix and Regeneron will also jointly develop diagnostic assets, with Telix leading commercialization and Regeneron receiving a set percentage of profits. 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, including  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 . About Telix Pharmaceuticals Limited Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in with the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Visit for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn , X and Facebook . 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 the planned research and clinical programs in collaboration with Telix Pharmaceuticals Limited (“Telix”) to develop radiopharmaceutical treatments and diagnostics as discussed in this press release; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) as well as Regeneron’s collaboration with Telix discussed in this press release, to be cancelled or terminated; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including those to be conducted as part of the collaboration with Telix discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the potential of combining for therapeutic purposes Regeneron’s expertise in biologics ( including bispecific antibody discovery) with Telix’s radiopharmaceutical development platform, global manufacturing, and supply chain infrastructure ; 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) on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; 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 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 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 ( ). Telix Contacts: Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com Telix Investor Relations (APAC) Ms. Charlene Jaw Associate Director Investor Relations charlene.jaw@telixpharma.com Telix Investor Relations (U.S.)  Ms. Annie Kasparian  Director Investor Relations and Corporate Communications  annie.kasparian@telixpharma.com Media Contact Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com Regeneron Contacts: Investors: Vesna Tosic +1-914-847-5443 vesna.tosic@regeneron.com Media: Ella Campbell +1-914-847-7017 ella.campbell@regeneron.com This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices Telix Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs, including with respect to any therapeutic radiopharmaceuticals that may be co-developed under Telix’s strategic collaboration with Regeneron; the potential for the collaboration agreement with Regeneron, or any other license, collaboration, or supply agreement, to be cancelled or terminated without achieving its objectives and at material cost to Telix; potential of future disputes with collaboration partners, licensees, vendors and other third parties; the potential of combining Telix’s radiopharmaceutical development platform, global manufacturing capabilities, and supply chain infrastructure with Regeneron’s expertise in biologics; the ability of Telix’s collaborators, licensees, suppliers, or other third parties to effectively perform research, development, manufacturing, distribution, and other steps related to Telix’s obligations, products and product candidates developed under the collaboration; the ability of Telix to manage supply chains for multiple products and product candidates developed independently or under the collaboration; Telix’s and its collaborator’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s or collaboration product candidates, ; Telix’s general sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s and collaboration product candidates, if or when they have been approved; uncertainty of the utilization, market acceptance, and commercial success of Telix’s products and product candidates developed under the collaboration; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates including those developed under the collaboration; estimates of Telix’s expenses, future revenues, capital requirements and financial obligations, or potential payments and profit share under the collaboration; Telix’s financial performance; developments relating to Telix’s competitors and industry, including potential competition with products produced by Regeneron outside the collaboration; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s and collaboration product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved.