{"success":true,"data":{"pressRelease":{"id":"5640","rtpr_id":"nGNX2xtsmv","ticker":"REGN","exchange":"NASDAQ","all_tickers":["REGN","SASY"],"title":"Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria","author":"Globe Newswire","published_at":"2026-04-22T21:30:00.454Z","article_body":"Sanofi and Regeneron’s Dupixent approved in the US as the first biologic\nmedicine for young children with uncontrolled chronic spontaneous urticaria\n* Approval for children aged two to 11 years with CSU who remain symptomatic\ndespite H1 antihistamine treatment based primarily on data from the\nLIBERTY-CUPID clinical study program\n* CSU is a chronic skin disease that causes itch and hives that can be\ndebilitating for young children, especially for those whose disease remains\nuncontrolled\n* CSU marks the fifth disease driven in part by type 2 inflammation for which\nDupixent is approved in children younger than 12 years of age\nParis and Tarrytown, NY, April 22, 2026. The US Food and Drug Administration\nhas approved Dupixent (dupilumab) for the treatment of children aged two to 11\nyears with chronic spontaneous urticaria (CSU) who remain symptomatic despite\nhistamine-1 antihistamine (H1AH) treatment. This expands the previous approval\n(https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131)\nfor Dupixent in adults and adolescents aged 12 years and older with CSU.\n\n“Children with uncontrolled chronic spontaneous urticaria continue to\nexperience the unpredictable appearance of debilitating itch and hives,”\nsaid Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology\nDevelopment at Sanofi. “Until now, these patients had to rely on limited\ntreatment options that didn’t address potential critical mediators of\nchronic spontaneous urticaria. Dupixent is the first biologic approved for\npatients as young as two years of age, offering a targeted approach that\ninhibits IL4 and IL13 signaling, two key and central drivers of the type 2\ninflammation that contributes to this disease. Today’s approval underscores\nour ongoing commitment to advancing therapies for young patients with\nsignificant unmet needs.”\n\nThe approval is based primarily on data from the LIBERTY-CUPID clinical study\nprogram. This includes extrapolation of efficacy and safety data from two\nphase 3 studies (Study A\n(https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-26-17-00-00-2392625)\nand Study C\n(https://www.sanofi.com/en/media-room/press-releases/2024/2024-10-24-12-00-00-2968628);\nclinical study identifier: NCT04180488) in certain adults and adolescents aged\n12 years and older with CSU complemented with pharmacokinetics data from the\nsingle-arm, CUPIDKids (clinical study identifier: NCT05526521) phase 3 study\nin children aged 2 to 11 years with CSU. In Study A and Study C, Dupixent\nsignificantly reduced itch severity and urticaria activity (a composite of\nitch and hives) compared to placebo at Week 24. In adults and adolescents,\nDupixent also increased the likelihood of well-controlled disease or complete\nresponse compared to placebo at Week 24. Study B\n(https://www.jacionline.org/article/S0091-6749(24)00196-9/fulltext) (clinical\nstudy identifier: NCT04180488) provided additional safety data and evaluated\nDupixent in patients aged 12 years and older who were inadequate responders or\nintolerant to anti-IgE therapy and symptomatic despite antihistamine use.\nSafety in children aged 2 to 11 years with CSU was supported by data from\npediatric patients in other indications.\n\nThe safety results from all four CSU studies were generally consistent with\nthe known safety profile of Dupixent in its approved dermatological\nindications. In Study A, Study B, and Study C, the most common adverse\nreaction (≥2%) in the US Prescribing Information more frequently observed in\npatients on Dupixent compared to placebo was injection site reactions. No new\nadverse reactions were identified in children aged 2 to 11 years with CSU\ntreated with Dupixent.\n\n“With this approval, Dupixent has become the first biologic medicine in the\nUS for young children suffering from uncontrolled chronic spontaneous\nurticaria, an unpredictable skin disease that impacts quality of life during\nthese children’s most formative years,” said George D. Yancopoulos, MD,\nPhD, Board co-Chair, President and Chief Scientific Officer at Regeneron.\n“Dupixent is now approved for nine different allergy-related conditions,\nfrom asthma to atopic dermatitis, and this is the fifth of these indications\nnow extended to young children. The FDA’s authorization reinforces our\nmedicine’s well-established safety profile and potential to transform\noutcomes for chronic diseases driven in part by type 2 inflammation impacting\nsome of the most vulnerable populations. As the most widely used innovative\nbranded antibody medicine, Dupixent, has the potential to change yet another\ntreatment paradigm.”\n\nIn addition to the US, Dupixent is approved\n(https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-13-05-00-00-3272182)\nfor CSU in certain children aged two to 11 years in the EU and other countries\naround the world.\n\nAbout CSU\n\nCSU is a chronic inflammatory skin disease driven in part by type 2\ninflammation, which causes sudden and debilitating hives and recurring itch.\nCSU is typically treated with H1AH, medicines that target H1 receptors on\ncells to control symptoms of itch and urticaria. However, the disease remains\nuncontrolled despite H1AH treatment in more than 14,000 children in the US\naged two to 11 years living with CSU, some of whom are left with limited\nalternative treatment options. These individuals continue to experience\nsymptoms that can be debilitating and significantly impact their quality of\nlife.\n\nAbout the Dupixent CSU phase 3 study program\n\nThe LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU in children aged\ntwo to 11 years consists of CUPIDKids, Study A, Study B and Study C.\nCUPIDKids was a single arm clinical study that assessed the safety, efficacy,\nand pharmacokinetics of Dupixent in children aged two to 11 years with CSU who\nremained symptomatic despite the use of antihistamines. During the 24-week\ntreatment period, Dupixent was administered at 200 mg every two (Q2W) or four\n(Q4W) weeks or 300 mg Q4W, with or without an initial loading dose, based on\nage and weight. The primary endpoint measured the serum concentration of\nDupixent over time, including C(trough) (lowest concentration before the next\ndose) at Week 12 and Week 24.\n\nStudy A and Study C were replicate, double-blind, placebo-controlled clinical\nstudies that assessed Dupixent as an add-on therapy to standard-of-care\nantihistamines compared to antihistamines alone in patients aged six years and\nolder who remained symptomatic despite the use of antihistamines and were\nnaïve to anti-Immunoglobulin E therapy. Study B was conducted in patients\naged 12 years and older who were symptomatic despite use of antihistamines and\nwere inadequate responders or intolerant to anti-IgE therapy. During the\n24-week treatment period in all three studies, all patients received an\ninitial loading dose followed by either 300 mg Dupixent Q2W or, for pediatric\npatients weighing 30 kg to <60 kg, 200 mg Q2W. In both studies, endpoints\nassessed at Week 24 included:\n* Change from baseline in itch (measured by the weekly itch severity score,\n0-21 scale), the primary endpoint\n* Change from baseline in itch and hives (weekly urticaria activity score\n[UAS7], 0-42 scale), the key secondary endpoint\n* Proportion of patients achieving well-controlled disease status (UAS7 ≤6)\n* Proportion of patients with complete response (UAS7=0)\nAbout Dupixent\nDupixent (dupilumab) is an injection administered under the skin (subcutaneous\ninjection) at different injection sites. In children aged two to 11 years with\nCSU who remain symptomatic despite H1AH treatment, Dupixent is administered\nbased on age and weight. In children aged two to five years, Dupixent is\nadministered at 200 mg Q4W for patients weighing ≥5 kg to <15 kg and 300 mg\nQ4W for ≥15 kg to <30 kg, without an initial loading dose. In children aged\nsix to 17 years, Dupixent is administered at 300 mg Q4W for ≥15 kg to <30\nkg, 200 mg Q2W for ≥30 kg to <60 kg, and 300mg Q2W for ≥60 kg, after an\ninitial loading dose. Dupixent is intended for use under the guidance of a\nhealthcare professional and can be given in a clinic or at home after training\nby a healthcare professional. In children aged two to 11 years, Dupixent\nshould be administered by a caregiver if given at home.\n\nDupixent is a fully human monoclonal antibody that inhibits the signaling of\nthe interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an\nimmunosuppressant. The Dupixent development program has shown significant\nclinical benefit and a decrease in type 2 inflammation in phase 3 studies,\nestablishing that IL4 and IL13 are two of the key and central drivers of the\ntype 2 inflammation that plays a major role in multiple related and often\nco-morbid diseases.\n\nSanofi and Regeneron are committed to helping patients in the US who are\nprescribed Dupixent gain access to the medicine and receive the support they\nmay need with the DUPIXENT MyWay(®) program. For more information, please\ncall 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.\n\nDupixent has received regulatory approvals in more than 60 countries in one or\nmore indications including certain patients with atopic dermatitis, asthma,\nchronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo\nnodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and\nallergic fungal rhinosinusitis in different age populations. More than 1.4\nmillion patients are being treated with Dupixent globally.\n\nDupilumab development program\nDupilumab is being jointly developed by Sanofi and Regeneron under a global\ncollaboration agreement. To date, dupilumab has been studied across more than\n60 clinical studies involving more than 12,000 patients with various chronic\ndiseases driven in part by type 2 inflammation.\n\nIn addition to the currently approved indications, Sanofi and Regeneron are\nstudying dupilumab in a broad range of diseases driven by type 2 inflammation\nor other allergic processes in phase 3 studies, including chronic pruritus of\nunknown origin and lichen simplex chronicus. These potential uses of dupilumab\nare currently under clinical investigation, and the safety and efficacy in\nthese conditions have not been fully evaluated by any regulatory authority.\n\nAbout Regeneron\nRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents,\ndevelops and commercializes life-transforming medicines for people with\nserious diseases. Founded and led by physician-scientists, our unique ability\nto repeatedly and consistently translate science into medicine has led to\nnumerous approved treatments and product candidates in development, most of\nwhich were homegrown in our laboratories. Our medicines and pipeline are\ndesigned to help patients with eye diseases, allergic and inflammatory\ndiseases, cancer, cardiovascular and metabolic diseases, neurological\ndiseases, hematologic conditions, infectious diseases, and rare diseases.\n\nRegeneron pushes the boundaries of scientific discovery and accelerates drug\ndevelopment using our proprietary technologies, such as\nVelociSuite(®), which produces optimized fully human antibodies and new\nclasses of bispecific antibodies. We are shaping the next frontier of\nmedicine with data-powered insights from the Regeneron Genetics\nCenter(®) and pioneering genetic medicine platforms, enabling us to identify\ninnovative targets and complementary approaches to potentially treat or cure\ndiseases.\n\nFor more information, please visit www.Regeneron.com or follow Regeneron on\nLinkedIn\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fregeneron-pharmaceuticals%2F&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237271743%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=yZvXrLVesHIpepxroLAffDN3VtRdbFPhuhbaflzETT8%3D&reserved=0),\nInstagram\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fregeneron&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237352013%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ssF5iJf4k5YW7kpmGrc1H14TAjU1JankIyV2%2FFaRe5g%3D&reserved=0),\nFacebook\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FRegeneron%2F&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237389560%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=z5o3oLKqWVpAfUcOZBU1l32gY9vJ5SEoCtwan4LEV90%3D&reserved=0)or\nX\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2FRegeneron&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237416664%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SjCmHLNuMGxkn94Nh7r4YkSAuWl2mWJs%2FwcFhxz1H8%3D&reserved=0).\n\nAbout Sanofi \nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time.\n\nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY.\n\nSanofi Media Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 420 926 6780 | ekaterina.pesheva@sanofi.com\n\nSanofi Investor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com \nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com\n\nRegeneron Media Relations\nIlana Yellen| +1 914-330-9618 | ilana.yellen@regeneron.com\n\nRegeneron Investor Relations\nMark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com\n\nSanofi forward-looking statements\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup except for VelociSuite and Regeneron Genetics Center.\n\nRegeneron Forward-Looking Statements and Use of Digital Media \nThis press release includes forward-looking statements that involve risks and\nuncertainties relating to future events and the future performance of\nRegeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and\nactual events or results may differ materially from these forward-looking\nstatements. Words such as “anticipate,” “expect,” “intend,”\n“plan,” “believe,” “seek,” “estimate,” variations of such\nwords, and similar expressions are intended to identify such forward-looking\nstatements, although not all forward-looking statements contain these\nidentifying words. These statements concern, and these risks and uncertainties\ninclude, among others, the nature, timing, and possible success and\ntherapeutic applications of products marketed or otherwise commercialized by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Products”) and product candidates being developed by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Product Candidates”) and research and clinical programs now\nunderway or planned, including without limitation Dupixent(®) (dupilumab) for\nthe treatment of children aged 2 to 11 years with chronic spontaneous\nurticaria; the likelihood, timing, and scope of possible regulatory approval\nand commercial launch of Regeneron’s Product Candidates and new indications\nfor Regeneron’s Products, including Dupixent for the treatment of chronic\npruritus of unknown origin, lichen simplex chronicus, and other potential\nindications; uncertainty of the utilization, market acceptance, and commercial\nsuccess of Regeneron’s Products (such as Dupixent) and Regeneron’s Product\nCandidates and the impact of studies (whether conducted by Regeneron or others\nand whether mandated or voluntary), including the studies discussed or\nreferenced in this press release, on any of the foregoing; the ability of\nRegeneron’s collaborators, licensees, suppliers, or other third parties (as\napplicable) to perform manufacturing, filling, finishing, packaging, labeling,\ndistribution, and other steps related to Regeneron’s Products and\nRegeneron’s Product Candidates; the ability of Regeneron to manage supply\nchains for multiple products and product candidates and risks associated with\ntariffs and other trade restrictions; safety issues resulting from the\nadministration of Regeneron’s Products (such as Dupixent) and Regeneron’s\nProduct Candidates in patients, including serious complications or side\neffects in connection with the use of Regeneron’s Products and Regeneron’s\nProduct Candidates in clinical trials; determinations by regulatory and\nadministrative governmental authorities which may delay or restrict\nRegeneron’s ability to continue to develop or commercialize Regeneron’s\nProducts and Regeneron’s Product Candidates; ongoing regulatory obligations\nand oversight impacting Regeneron’s Products, research and clinical\nprograms, and business, including those relating to patient privacy; the\navailability and extent of reimbursement or copay assistance for Regeneron’s\nProducts from third-party payors and other third parties, including private\npayor healthcare and insurance programs, health maintenance organizations,\npharmacy benefit management companies, and government programs such as\nMedicare and Medicaid; coverage and reimbursement determinations by such\npayors and other third parties and new policies and procedures adopted by such\npayors and other third parties; changes to drug pricing regulations and\nrequirements and Regeneron’s pricing strategy; other changes in laws,\nregulations, and policies affecting the healthcare industry; competing\nproducts and product candidates (including biosimilar products) that may be\nsuperior to, or more cost effective than, Regeneron’s Products and\nRegeneron’s Product Candidates; the extent to which the results from the\nresearch and development programs conducted by Regeneron and/or its\ncollaborators or licensees may be replicated in other studies and/or lead to\nadvancement of product candidates to clinical trials, therapeutic\napplications, or regulatory approval; unanticipated expenses; the costs of\ndeveloping, producing, and selling products; the ability of Regeneron to meet\nany of its financial projections or guidance and changes to the assumptions\nunderlying those projections or guidance; the potential for any license,\ncollaboration, or supply agreement, including Regeneron’s agreements with\nSanofi and Bayer (or their respective affiliated companies, as applicable), to\nbe cancelled or terminated; the impact of public health outbreaks, epidemics,\nor pandemics on Regeneron's business; and risks associated with litigation and\nother proceedings and government investigations relating to the Company and/or\nits operations (including the pending civil proceedings initiated or joined by\nthe U.S. Department of Justice and the U.S. Attorney's Office for the District\nof Massachusetts), risks associated with intellectual property of other\nparties and pending or future litigation relating thereto (including without\nlimitation the patent litigation and other related proceedings relating to\nEYLEA(®) (aflibercept) Injection), the ultimate outcome of any such\nproceedings and investigations, and the impact any of the foregoing may have\non Regeneron’s business, prospects, operating results, and financial\ncondition. A more complete description of these and other material risks can\nbe found in Regeneron’s filings with the U.S. Securities and Exchange\nCommission, including its Form 10-K for the year ended December 31, 2025. Any\nforward-looking statements are made based on management’s current beliefs\nand judgment, and the reader is cautioned not to rely on any forward-looking\nstatements made by Regeneron. Regeneron does not undertake any obligation to\nupdate (publicly or otherwise) any forward-looking statement, including\nwithout limitation any financial projection or guidance, whether as a result\nof new information, future events, or otherwise.\n\nRegeneron uses its media and investor relations website and social media\noutlets to publish important information about the Company, including\ninformation that may be deemed material to investors. Financial and other\ninformation about Regeneron is routinely posted and is accessible on\nRegeneron's media and investor relations website\n(https://investor.regeneron.com) and its LinkedIn page\n(https://www.linkedin.com/company/regeneron-pharmaceuticals).\n\nAttachment\n*     Press Release\n(https://ml-eu.globenewswire.com/Resource/Download/6a479c2b-6dc9-4e8d-b08c-17a681edfd91)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/06da731a-67a1-4258-939f-6ef0531ee3bf)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX2xtsmv","title":"Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria","author":"Globe Newswire","ticker":"REGN","created":"2026-04-22T21:30:00.454Z","tickers":["REGN","SASY"],"exchange":"NASDAQ","article_body":"Sanofi and Regeneron’s Dupixent approved in the US as the first biologic\nmedicine for young children with uncontrolled chronic spontaneous urticaria\n* Approval for children aged two to 11 years with CSU who remain symptomatic\ndespite H1 antihistamine treatment based primarily on data from the\nLIBERTY-CUPID clinical study program\n* CSU is a chronic skin disease that causes itch and hives that can be\ndebilitating for young children, especially for those whose disease remains\nuncontrolled\n* CSU marks the fifth disease driven in part by type 2 inflammation for which\nDupixent is approved in children younger than 12 years of age\nParis and Tarrytown, NY, April 22, 2026. The US Food and Drug Administration\nhas approved Dupixent (dupilumab) for the treatment of children aged two to 11\nyears with chronic spontaneous urticaria (CSU) who remain symptomatic despite\nhistamine-1 antihistamine (H1AH) treatment. This expands the previous approval\n(https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131)\nfor Dupixent in adults and adolescents aged 12 years and older with CSU.\n\n“Children with uncontrolled chronic spontaneous urticaria continue to\nexperience the unpredictable appearance of debilitating itch and hives,”\nsaid Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology\nDevelopment at Sanofi. “Until now, these patients had to rely on limited\ntreatment options that didn’t address potential critical mediators of\nchronic spontaneous urticaria. Dupixent is the first biologic approved for\npatients as young as two years of age, offering a targeted approach that\ninhibits IL4 and IL13 signaling, two key and central drivers of the type 2\ninflammation that contributes to this disease. Today’s approval underscores\nour ongoing commitment to advancing therapies for young patients with\nsignificant unmet needs.”\n\nThe approval is based primarily on data from the LIBERTY-CUPID clinical study\nprogram. This includes extrapolation of efficacy and safety data from two\nphase 3 studies (Study A\n(https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-26-17-00-00-2392625)\nand Study C\n(https://www.sanofi.com/en/media-room/press-releases/2024/2024-10-24-12-00-00-2968628);\nclinical study identifier: NCT04180488) in certain adults and adolescents aged\n12 years and older with CSU complemented with pharmacokinetics data from the\nsingle-arm, CUPIDKids (clinical study identifier: NCT05526521) phase 3 study\nin children aged 2 to 11 years with CSU. In Study A and Study C, Dupixent\nsignificantly reduced itch severity and urticaria activity (a composite of\nitch and hives) compared to placebo at Week 24. In adults and adolescents,\nDupixent also increased the likelihood of well-controlled disease or complete\nresponse compared to placebo at Week 24. Study B\n(https://www.jacionline.org/article/S0091-6749(24)00196-9/fulltext) (clinical\nstudy identifier: NCT04180488) provided additional safety data and evaluated\nDupixent in patients aged 12 years and older who were inadequate responders or\nintolerant to anti-IgE therapy and symptomatic despite antihistamine use.\nSafety in children aged 2 to 11 years with CSU was supported by data from\npediatric patients in other indications.\n\nThe safety results from all four CSU studies were generally consistent with\nthe known safety profile of Dupixent in its approved dermatological\nindications. In Study A, Study B, and Study C, the most common adverse\nreaction (≥2%) in the US Prescribing Information more frequently observed in\npatients on Dupixent compared to placebo was injection site reactions. No new\nadverse reactions were identified in children aged 2 to 11 years with CSU\ntreated with Dupixent.\n\n“With this approval, Dupixent has become the first biologic medicine in the\nUS for young children suffering from uncontrolled chronic spontaneous\nurticaria, an unpredictable skin disease that impacts quality of life during\nthese children’s most formative years,” said George D. Yancopoulos, MD,\nPhD, Board co-Chair, President and Chief Scientific Officer at Regeneron.\n“Dupixent is now approved for nine different allergy-related conditions,\nfrom asthma to atopic dermatitis, and this is the fifth of these indications\nnow extended to young children. The FDA’s authorization reinforces our\nmedicine’s well-established safety profile and potential to transform\noutcomes for chronic diseases driven in part by type 2 inflammation impacting\nsome of the most vulnerable populations. As the most widely used innovative\nbranded antibody medicine, Dupixent, has the potential to change yet another\ntreatment paradigm.”\n\nIn addition to the US, Dupixent is approved\n(https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-13-05-00-00-3272182)\nfor CSU in certain children aged two to 11 years in the EU and other countries\naround the world.\n\nAbout CSU\n\nCSU is a chronic inflammatory skin disease driven in part by type 2\ninflammation, which causes sudden and debilitating hives and recurring itch.\nCSU is typically treated with H1AH, medicines that target H1 receptors on\ncells to control symptoms of itch and urticaria. However, the disease remains\nuncontrolled despite H1AH treatment in more than 14,000 children in the US\naged two to 11 years living with CSU, some of whom are left with limited\nalternative treatment options. These individuals continue to experience\nsymptoms that can be debilitating and significantly impact their quality of\nlife.\n\nAbout the Dupixent CSU phase 3 study program\n\nThe LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU in children aged\ntwo to 11 years consists of CUPIDKids, Study A, Study B and Study C.\nCUPIDKids was a single arm clinical study that assessed the safety, efficacy,\nand pharmacokinetics of Dupixent in children aged two to 11 years with CSU who\nremained symptomatic despite the use of antihistamines. During the 24-week\ntreatment period, Dupixent was administered at 200 mg every two (Q2W) or four\n(Q4W) weeks or 300 mg Q4W, with or without an initial loading dose, based on\nage and weight. The primary endpoint measured the serum concentration of\nDupixent over time, including C(trough) (lowest concentration before the next\ndose) at Week 12 and Week 24.\n\nStudy A and Study C were replicate, double-blind, placebo-controlled clinical\nstudies that assessed Dupixent as an add-on therapy to standard-of-care\nantihistamines compared to antihistamines alone in patients aged six years and\nolder who remained symptomatic despite the use of antihistamines and were\nnaïve to anti-Immunoglobulin E therapy. Study B was conducted in patients\naged 12 years and older who were symptomatic despite use of antihistamines and\nwere inadequate responders or intolerant to anti-IgE therapy. During the\n24-week treatment period in all three studies, all patients received an\ninitial loading dose followed by either 300 mg Dupixent Q2W or, for pediatric\npatients weighing 30 kg to <60 kg, 200 mg Q2W. In both studies, endpoints\nassessed at Week 24 included:\n* Change from baseline in itch (measured by the weekly itch severity score,\n0-21 scale), the primary endpoint\n* Change from baseline in itch and hives (weekly urticaria activity score\n[UAS7], 0-42 scale), the key secondary endpoint\n* Proportion of patients achieving well-controlled disease status (UAS7 ≤6)\n* Proportion of patients with complete response (UAS7=0)\nAbout Dupixent\nDupixent (dupilumab) is an injection administered under the skin (subcutaneous\ninjection) at different injection sites. In children aged two to 11 years with\nCSU who remain symptomatic despite H1AH treatment, Dupixent is administered\nbased on age and weight. In children aged two to five years, Dupixent is\nadministered at 200 mg Q4W for patients weighing ≥5 kg to <15 kg and 300 mg\nQ4W for ≥15 kg to <30 kg, without an initial loading dose. In children aged\nsix to 17 years, Dupixent is administered at 300 mg Q4W for ≥15 kg to <30\nkg, 200 mg Q2W for ≥30 kg to <60 kg, and 300mg Q2W for ≥60 kg, after an\ninitial loading dose. Dupixent is intended for use under the guidance of a\nhealthcare professional and can be given in a clinic or at home after training\nby a healthcare professional. In children aged two to 11 years, Dupixent\nshould be administered by a caregiver if given at home.\n\nDupixent is a fully human monoclonal antibody that inhibits the signaling of\nthe interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an\nimmunosuppressant. The Dupixent development program has shown significant\nclinical benefit and a decrease in type 2 inflammation in phase 3 studies,\nestablishing that IL4 and IL13 are two of the key and central drivers of the\ntype 2 inflammation that plays a major role in multiple related and often\nco-morbid diseases.\n\nSanofi and Regeneron are committed to helping patients in the US who are\nprescribed Dupixent gain access to the medicine and receive the support they\nmay need with the DUPIXENT MyWay(®) program. For more information, please\ncall 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.\n\nDupixent has received regulatory approvals in more than 60 countries in one or\nmore indications including certain patients with atopic dermatitis, asthma,\nchronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo\nnodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and\nallergic fungal rhinosinusitis in different age populations. More than 1.4\nmillion patients are being treated with Dupixent globally.\n\nDupilumab development program\nDupilumab is being jointly developed by Sanofi and Regeneron under a global\ncollaboration agreement. To date, dupilumab has been studied across more than\n60 clinical studies involving more than 12,000 patients with various chronic\ndiseases driven in part by type 2 inflammation.\n\nIn addition to the currently approved indications, Sanofi and Regeneron are\nstudying dupilumab in a broad range of diseases driven by type 2 inflammation\nor other allergic processes in phase 3 studies, including chronic pruritus of\nunknown origin and lichen simplex chronicus. These potential uses of dupilumab\nare currently under clinical investigation, and the safety and efficacy in\nthese conditions have not been fully evaluated by any regulatory authority.\n\nAbout Regeneron\nRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents,\ndevelops and commercializes life-transforming medicines for people with\nserious diseases. Founded and led by physician-scientists, our unique ability\nto repeatedly and consistently translate science into medicine has led to\nnumerous approved treatments and product candidates in development, most of\nwhich were homegrown in our laboratories. Our medicines and pipeline are\ndesigned to help patients with eye diseases, allergic and inflammatory\ndiseases, cancer, cardiovascular and metabolic diseases, neurological\ndiseases, hematologic conditions, infectious diseases, and rare diseases.\n\nRegeneron pushes the boundaries of scientific discovery and accelerates drug\ndevelopment using our proprietary technologies, such as\nVelociSuite(®), which produces optimized fully human antibodies and new\nclasses of bispecific antibodies. We are shaping the next frontier of\nmedicine with data-powered insights from the Regeneron Genetics\nCenter(®) and pioneering genetic medicine platforms, enabling us to identify\ninnovative targets and complementary approaches to potentially treat or cure\ndiseases.\n\nFor more information, please visit www.Regeneron.com or follow Regeneron on\nLinkedIn\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fregeneron-pharmaceuticals%2F&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237271743%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=yZvXrLVesHIpepxroLAffDN3VtRdbFPhuhbaflzETT8%3D&reserved=0),\nInstagram\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fregeneron&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237352013%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ssF5iJf4k5YW7kpmGrc1H14TAjU1JankIyV2%2FFaRe5g%3D&reserved=0),\nFacebook\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FRegeneron%2F&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237389560%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=z5o3oLKqWVpAfUcOZBU1l32gY9vJ5SEoCtwan4LEV90%3D&reserved=0)or\nX\n(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2FRegeneron&data=05%7C02%7CNathan.Illsley%40sanofi.com%7Cb4e3a852621744ba9e5b08de284ed5f3%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638992516237416664%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SjCmHLNuMGxkn94Nh7r4YkSAuWl2mWJs%2FwcFhxz1H8%3D&reserved=0).\n\nAbout Sanofi \nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time.\n\nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY.\n\nSanofi Media Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 420 926 6780 | ekaterina.pesheva@sanofi.com\n\nSanofi Investor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com \nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com\n\nRegeneron Media Relations\nIlana Yellen| +1 914-330-9618 | ilana.yellen@regeneron.com\n\nRegeneron Investor Relations\nMark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com\n\nSanofi forward-looking statements\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup except for VelociSuite and Regeneron Genetics Center.\n\nRegeneron Forward-Looking Statements and Use of Digital Media \nThis press release includes forward-looking statements that involve risks and\nuncertainties relating to future events and the future performance of\nRegeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and\nactual events or results may differ materially from these forward-looking\nstatements. Words such as “anticipate,” “expect,” “intend,”\n“plan,” “believe,” “seek,” “estimate,” variations of such\nwords, and similar expressions are intended to identify such forward-looking\nstatements, although not all forward-looking statements contain these\nidentifying words. These statements concern, and these risks and uncertainties\ninclude, among others, the nature, timing, and possible success and\ntherapeutic applications of products marketed or otherwise commercialized by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Products”) and product candidates being developed by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Product Candidates”) and research and clinical programs now\nunderway or planned, including without limitation Dupixent(®) (dupilumab) for\nthe treatment of children aged 2 to 11 years with chronic spontaneous\nurticaria; the likelihood, timing, and scope of possible regulatory approval\nand commercial launch of Regeneron’s Product Candidates and new indications\nfor Regeneron’s Products, including Dupixent for the treatment of chronic\npruritus of unknown origin, lichen simplex chronicus, and other potential\nindications; uncertainty of the utilization, market acceptance, and commercial\nsuccess of Regeneron’s Products (such as Dupixent) and Regeneron’s Product\nCandidates and the impact of studies (whether conducted by Regeneron or others\nand whether mandated or voluntary), including the studies discussed or\nreferenced in this press release, on any of the foregoing; the ability of\nRegeneron’s collaborators, licensees, suppliers, or other third parties (as\napplicable) to perform manufacturing, filling, finishing, packaging, labeling,\ndistribution, and other steps related to Regeneron’s Products and\nRegeneron’s Product Candidates; the ability of Regeneron to manage supply\nchains for multiple products and product candidates and risks associated with\ntariffs and other trade restrictions; safety issues resulting from the\nadministration of Regeneron’s Products (such as Dupixent) and Regeneron’s\nProduct Candidates in patients, including serious complications or side\neffects in connection with the use of Regeneron’s Products and Regeneron’s\nProduct Candidates in clinical trials; determinations by regulatory and\nadministrative governmental authorities which may delay or restrict\nRegeneron’s ability to continue to develop or commercialize Regeneron’s\nProducts and Regeneron’s Product Candidates; ongoing regulatory obligations\nand oversight impacting Regeneron’s Products, research and clinical\nprograms, and business, including those relating to patient privacy; the\navailability and extent of reimbursement or copay assistance for Regeneron’s\nProducts from third-party payors and other third parties, including private\npayor healthcare and insurance programs, health maintenance organizations,\npharmacy benefit management companies, and government programs such as\nMedicare and Medicaid; coverage and reimbursement determinations by such\npayors and other third parties and new policies and procedures adopted by such\npayors and other third parties; changes to drug pricing regulations and\nrequirements and Regeneron’s pricing strategy; other changes in laws,\nregulations, and policies affecting the healthcare industry; competing\nproducts and product candidates (including biosimilar products) that may be\nsuperior to, or more cost effective than, Regeneron’s Products and\nRegeneron’s Product Candidates; the extent to which the results from the\nresearch and development programs conducted by Regeneron and/or its\ncollaborators or licensees may be replicated in other studies and/or lead to\nadvancement of product candidates to clinical trials, therapeutic\napplications, or regulatory approval; unanticipated expenses; the costs of\ndeveloping, producing, and selling products; the ability of Regeneron to meet\nany of its financial projections or guidance and changes to the assumptions\nunderlying those projections or guidance; the potential for any license,\ncollaboration, or supply agreement, including Regeneron’s agreements with\nSanofi and Bayer (or their respective affiliated companies, as applicable), to\nbe cancelled or terminated; the impact of public health outbreaks, epidemics,\nor pandemics on Regeneron's business; and risks associated with litigation and\nother proceedings and government investigations relating to the Company and/or\nits operations (including the pending civil proceedings initiated or joined by\nthe U.S. Department of Justice and the U.S. Attorney's Office for the District\nof Massachusetts), risks associated with intellectual property of other\nparties and pending or future litigation relating thereto (including without\nlimitation the patent litigation and other related proceedings relating to\nEYLEA(®) (aflibercept) Injection), the ultimate outcome of any such\nproceedings and investigations, and the impact any of the foregoing may have\non Regeneron’s business, prospects, operating results, and financial\ncondition. A more complete description of these and other material risks can\nbe found in Regeneron’s filings with the U.S. Securities and Exchange\nCommission, including its Form 10-K for the year ended December 31, 2025. Any\nforward-looking statements are made based on management’s current beliefs\nand judgment, and the reader is cautioned not to rely on any forward-looking\nstatements made by Regeneron. Regeneron does not undertake any obligation to\nupdate (publicly or otherwise) any forward-looking statement, including\nwithout limitation any financial projection or guidance, whether as a result\nof new information, future events, or otherwise.\n\nRegeneron uses its media and investor relations website and social media\noutlets to publish important information about the Company, including\ninformation that may be deemed material to investors. Financial and other\ninformation about Regeneron is routinely posted and is accessible on\nRegeneron's media and investor relations website\n(https://investor.regeneron.com) and its LinkedIn page\n(https://www.linkedin.com/company/regeneron-pharmaceuticals).\n\nAttachment\n*     Press Release\n(https://ml-eu.globenewswire.com/Resource/Download/6a479c2b-6dc9-4e8d-b08c-17a681edfd91)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/06da731a-67a1-4258-939f-6ef0531ee3bf)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-04-22T21:30:00.513635827Z","server_sent_at_ms":1776893400513},"received_at":"2026-04-22T21:30:02.449Z","source_url":null},"analysis":{"id":"4132","press_release_id":"5640","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"The FDA approved Dupixent for children aged two to 11 with uncontrolled chronic spontaneous urticaria, making it the first biologic for this indication in that young age group.\n\nApproval was based on extrapolated efficacy data from Phase 3 studies in adults and adolescents, complemented by pediatric pharmacokinetic data showing consistent safety and exposure.\n\nThis is the fifth type 2 inflammation indication for Dupixent in children under 12, further extending the reach of a product already used by more than 1.4 million patients globally.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Dupixent extends its pediatric dominance with first-in-class FDA approval for young children with chronic spontaneous urticaria."},"keyFigures":{"drugName":"Dupixent (dupilumab)","customDimensions":{"patients_on_dupixent_global":"more than 1.4 million","us_pediatric_csu_uncontrolled":"more than 14,000"}},"quotedText":"Dupixent is the first biologic approved for patients as young as two years of age, offering a targeted approach that inhibits IL4 and IL13 signaling","namedEntities":{"people":[{"name":"Alyssa Johnsen","role":"Global Therapeutic Area Head, Immunology Development at Sanofi"},{"name":"George D. Yancopoulos","role":"Board co-Chair, President and Chief Scientific Officer at Regeneron"}],"products":["Dupixent","dupilumab","DUPIXENT MyWay"],"companies":[{"name":"Sanofi","ticker":"SNY","relationship":"partner"},{"name":"Regeneron","ticker":"REGN","relationship":"partner"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"FDA approval for Dupixent in children aged 2-11 with CSU expands the addressable market for Regeneron's key asset. While significant, it is an incremental expansion of an existing blockbuster drug rather than a first-ever binary approval."},"tickerRelevance":{"others":[{"ticker":"SNY","relevance":"partner"}],"primary":"REGN"},"eventTypeSecondary":[]},"event_type":"fda_approval","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"The FDA approved Dupixent for children aged two to 11 with uncontrolled chronic spontaneous urticaria, making it the first biologic for this indication in that young age group.\n\nApproval was based on extrapolated efficacy data from Phase 3 studies in adults and adolescents, complemented by pediatric pharmacokinetic data showing consistent safety and exposure.\n\nThis is the fifth type 2 inflammation indication for Dupixent in children under 12, further extending the reach of a product already used by more than 1.4 million patients globally.","key_figures":{"drugName":"Dupixent (dupilumab)","customDimensions":{"patients_on_dupixent_global":"more than 1.4 million","us_pediatric_csu_uncontrolled":"more than 14,000"}},"named_entities":{"people":[{"name":"Alyssa Johnsen","role":"Global Therapeutic Area Head, Immunology Development at Sanofi"},{"name":"George D. Yancopoulos","role":"Board co-Chair, President and Chief Scientific Officer at Regeneron"}],"products":["Dupixent","dupilumab","DUPIXENT MyWay"],"companies":[{"name":"Sanofi","ticker":"SNY","relationship":"partner"},{"name":"Regeneron","ticker":"REGN","relationship":"partner"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:2f2748f0fcc8c4f2","schema_hash":"sha256:ad96b863d7123008","created_at":"2026-04-23T00:35:27.657Z","global_importance":3,"audience_relevance":3,"importance_components":{"method":"backfill-heuristic","signals":{"bodyLong":false,"headlineTier1":false,"tickerCovered":false,"hadSignificance":false},"version":1,"computedAt":"2026-04-27T11:52:54.537Z"}},"durationMs":37726,"modelName":"glm-4.7"}}