Imdevimab

Normalization of free light chains occurred by day 15 across all doses 100% of patients achieved a hematologic complete response (CR) at the highest tested dose Majority of patients with renal or cardiac involvement demonstrated improvement in organ function, despite short follow-up First results from the Phase 1/2 LINKER-AL2 trial to be detailed in an ASCO oral presentation; the Phase 2 portion of the trial with registrational intent is ongoing TARRYTOWN, N.Y. , May 21, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from the Phase 1/2 LINKER-AL2 trial evaluating Lynozyfic® (linvoseltamab) in adults with second-line-plus systemic amyloid light chain (AL) amyloidosis, which will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting on Friday, May 29 at 2:45 p.m. CDT . The Phase 2 portion of the trial with registrational intent is underway, part of a broad clinical development program investigating Lynozyfic. Lynozyfic is a BCMAxCD3 bispecific antibody that is already approved to treat certain adults with relapsed or refractory (R/R) multiple myeloma (MM). Systemic AL amyloidosis is a rare and potentially fatal hematologic disorder for which there are currently no approved therapies after initial treatment fails. The disorder is characterized by plasma cells that produce abnormal light chain proteins, which clump together to form amyloid deposits in tissues and vital organs (e.g., heart, kidneys, etc.), resulting in life-threatening organ dysfunction. The current standard-of-care for initial treatment is a four-drug combination that includes daratumumab, bortezomib, cyclophosphamide and dexamethasone. In first-line treatment, this daratumumab-and-chemotherapy-containing quadruple combination showed a 53% hematologic complete response (CR), with a median time to response of 59 days per historical clinical data. In LINKER-AL2, the safety and efficacy of Lynozyfic as a monotherapy was evaluated in patients who received at least one prior therapy, and were either relapsed, refractory or had a suboptimal response (“second-line-plus”). "The nearly 100% hematologic complete response rate in previously treated systemic AL amyloidosis is remarkable given the 53% hematologic complete response rate with the standard-of-care, multi-drug combination in untreated patients with similar median follow up. Coupled with the notable major organ responses seen in those receiving linvoseltamab monotherapy, these data support further investigation as a promising treatment for these patients,” said Hans Lee , M.D., Director of Myeloma Research for Sarah Cannon Research Institute and investigator for the LINKER-AL2 trial. “The stark reality for patients with systemic AL amyloidosis facing relapsed or refractory disease is that there are no approved treatment options for them. They are grappling with life-threatening organ deterioration, which demands urgent therapeutic innovation. We look forward to the data maturing to better understand if these results can be maintained and translate to further organ improvement.” LINKER-AL2 is an ongoing, open-label, Phase 1/2 trial investigating the safety and efficacy of fixed-duration Lynozyfic monotherapy in adults with second-line-plus systemic AL amyloidosis. The primary endpoint in Phase 1 was the incidence of dose-limiting toxicities through 28 days. In the ongoing Phase 2 portion of the trial, the primary endpoint is the achievement of hematologic CR. In the preliminary analysis, 20 patients received Lynozyfic 80 mg (n=7) or 240 mg (n=13) subcutaneously, including 60% who previously received a daratumumab-containing regimen. With a median follow-up of 9.5 months (range: 1.6-13.3 months), Lynozyfic had no observed dose-limiting toxicities, with additional results across both doses showing: Hematologic responses in all patients: In the lower-dose group (80 mg), 100% (7 of 7) achieved a very good partial response (VGPR) or better, and 71% (5 of 7) achieved a CR; in the higher-dose group (240 mg), 100% achieved a CR (13 of 13). Responses were durable, with no hematologic progression occurring in all 17 patients still in the trial. Rapid and deep reductions in involved free light chain (iFLC) that normalized by day 15, showing that Lynozyfic treatment rapidly destroyed the plasma cells that produce the abnormal light chains in systemic AL amyloidosis. Further, median time to hematologic CR was 47 days (range: 7-240 days). Notable responses associated with improved renal (73%; 8 of 11) and cardiac (50%; 4 of 8 by biochemical response) organ function, with no patients experiencing major organ deterioration. Across both dose levels, all patients (n=20) treated with Lynozyfic monotherapy experienced ≥1 treatment-emergent adverse event (TEAE) (Grade ≥3: 65%), with the most common being cytokine release syndrome (50%; no Grade ≥3), neutropenia (40%; Grade 3/4: 35%) and infusion-related reactions (35%; no Grade ≥3). A total of 17 patients (85%) experienced infections (Grade ≥3: 25%), all of which were resolved. Additionally, there was one Grade 1 incidence of immune effector cell-associated neurotoxicity syndrome that was resolved. One patient in the 240 mg cohort discontinued treatment due to AEs (pneumonia) after achieving CR following three cycles of treatment. Additionally, one patient in the 240 mg cohort with a hematologic CR experienced sudden death in the context of cardiac amyloidosis; and one patient in the 80 mg cohort with pre-existing coronary artery disease had fatal ventricular fibrillation within 24 hours of coronary artery stent placement, which was assessed as unrelated to Lynozyfic by the investigator. The use of Lynozyfic described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication. About Systemic Amyloid Light Chain (AL) AmyloidosisSystemic AL amyloidosis is a rare and potentially fatal hematologic disorder that is characterized by the abnormal production of immunoglobulin light chains by clonal plasma cells in the bone marrow. These misfolded light chains form insoluble amyloid protein deposits in vital organs and tissues throughout the body, including the heart (>75% of patients) and kidneys (>60% of patients), leading to organ dysfunction or failure. The estimated U.S. incidence rate is approximately 4,400 cases per year. Systemic AL amyloidosis remains largely incurable, and there are currently no approved therapies for this devastating condition in patients who previously received a daratumumab-quadruple combination. About LynozyficLynozyfic was invented using Regeneron’s VelocImmune® technology and is a fully human BCMAxCD3 bispecific antibody designed to bridge BCMA on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. Lynozyfic is approved to treat certain adults with R/R MM: in the U.S. after four lines of therapy and in the European Union after at least three prior therapies. In the U.S., the generic name for Lynozyfic in its approved indications is linvoseltamab-gcpt, with gcpt as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Lynozyfic in its approved indications is linvoseltamab. Lynozyfic is being investigated in a broad clinical development program exploring its use as a monotherapy and in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.  In addition to LINKER-AL2, ongoing trials include: LINKER-MM1: Phase 1/2 dose-escalation and dose-expansion trial evaluating the safety, tolerability, dose-limiting toxicities and anti-tumor activity of Lynozyfic monotherapy in R/R MM LINKER-MM2: Phase 1b open-label trial evaluating Lynozyfic in combination with other cancer treatments in patients with R/R MM LINKER-MM3: Phase 3 confirmatory trial evaluating Lynozyfic monotherapy compared to the combination of elotuzumab, pomalidomide and dexamethasone in R/R MM LINKER-MM4: Phase 1/2 trial evaluating Lynozyfic monotherapy in newly diagnosed multiple myeloma (NDMM) LINKER-MM5: Phase 3 trial evaluating Lynozyfic monotherapy or in combination with carfilzomib compared to standard of care combination regimens in patients with R/R MM LINKER-MM6 (EMN39): Phase 3 trial, in collaboration with the European Myeloma Network, evaluating daratumumab, lenalidomide and dexamethasone induction followed by Lynozyfic monotherapy compared to continued daratumumab, lenalidomide, and dexamethasone in NDMM who are transplant-ineligible Phase 1 trial: evaluating Lynozyfic in combination with a Regeneron CD38xCD28 costimulatory bispecific monoclonal antibody in R/R MM Phase 1 trial: evaluating Lynozyfic in combination with a Regeneron anti-GPRC5D x anti-CD28 costimulatory bispecific monoclonal antibody in R/R MM LINKER-SMM1: Phase 2 trial evaluating Lynozyfic monotherapy in high-risk smoldering MM LINKER-MGUS1: Phase 2 dose-ranging trial evaluating Lynozyfic monotherapy in high-risk monoclonal gammopathy of unknown significance and non-high-risk smoldering MM For more information on Regeneron’s clinical trials in blood disorders, visit the clinical trials website, or contact via clinicaltrials@regeneron.com or 844-734-6643. IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS What is the most important information I should know about LYNOZYFIC?LYNOZYFIC may cause serious or life-threatening side effects, including Cytokine Release Syndrome (CRS) and infusion-related reactions (IRR), or neurologic problems. Cytokine Release Syndrome (CRS) and infusion related reactions (IRR). CRS is common during treatment with LYNOZYFIC and can also be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS or IRR, including: fever of 100.4ºF (38ºC) or higher chills or shaking trouble breathing fast heartbeat dizziness or light-headedness Neurologic problems. LYNOZYFIC can cause neurologic problems that can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including: headache agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations) trouble speaking, writing, thinking, remembering things, paying attention, or understanding things problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms numbness and tingling (feeling like “pins and needles”) burning, throbbing, or stabbing pain changes in your handwriting seizures Due to the risk of CRS and neurologic problems, you will receive LYNOZYFIC on a “step-up dosing schedule” and should be hospitalized for 24 hours after the first and second “step-up” doses. During the “step-up dosing schedule”: For your first dose, you will receive a smaller “step-up” dose of LYNOZYFIC on Day 1 of your treatment. For your second dose, you will receive a larger “step-up” dose of LYNOZYFIC, which is usually given on Day 8 of your treatment. For your third dose, you will receive the first treatment dose of LYNOZYFIC, which is usually given on Day 15 of your treatment. Your healthcare provider may repeat one or both of the “step-up” doses depending on side effects or if your treatment is delayed. Before the “step-up” doses and the first two treatment doses of LYNOZYFIC, you will receive medicines to help reduce your risk of CRS and IRR. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of side effects with future doses. For your first dose, you will receive a smaller “step-up” dose of LYNOZYFIC on Day 1 of your treatment. For your second dose, you will receive a larger “step-up” dose of LYNOZYFIC, which is usually given on Day 8 of your treatment. For your third dose, you will receive the first treatment dose of LYNOZYFIC, which is usually given on Day 15 of your treatment. Your healthcare provider may repeat one or both of the “step-up” doses depending on side effects or if your treatment is delayed. Before the “step-up” doses and the first two treatment doses of LYNOZYFIC, you will receive medicines to help reduce your risk of CRS and IRR. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of side effects with future doses. LYNOZYFIC is available only through the LYNOZYFIC Risk Evaluation and Mitigation Strategy (REMS) due to the risk of side effects of CRS and neurologic problems. You will receive a Patient Wallet Card from your healthcare provider. Carry the LYNOZYFIC Patient Wallet Card with you at all times and show it to all of your healthcare providers. The LYNOZYFIC Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the LYNOZYFIC Patient Wallet Card. You may need to be treated in a hospital. Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with LYNOZYFIC, as well as other side effects, and may treat you in a hospital if needed. Your healthcare provider may temporarily stop or completely stop your treatment with LYNOZYFIC if you develop CRS, neurologic problems, or any other severe side effects. If you have any questions about LYNOZYFIC, ask your healthcare provider. Before receiving LYNOZYFIC, tell your healthcare provider about all of your medical conditions, including if you: have an infection. are pregnant or plan to become pregnant. LYNOZYFIC may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with LYNOZYFIC.Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with LYNOZYFIC. You should use an effective form of birth control (contraception) during treatment with LYNOZYFIC and for 3 months after your last dose of LYNOZYFIC. are breastfeeding or plan to breastfeed. It is not known whether LYNOZYFIC passes into your breast milk. Do not breastfeed during treatment with LYNOZYFIC and for 3 months after your last dose of LYNOZYFIC. Your healthcare provider should do a pregnancy test before you start treatment with LYNOZYFIC. You should use an effective form of birth control (contraception) during treatment with LYNOZYFIC and for 3 months after your last dose of LYNOZYFIC. are breastfeeding or plan to breastfeed. It is not known whether LYNOZYFIC passes into your breast milk. Do not breastfeed during treatment with LYNOZYFIC and for 3 months after your last dose of LYNOZYFIC. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive LYNOZYFIC? LYNOZYFIC will be given to you by your healthcare provider by infusion through a needle placed in a vein (intravenous infusion). After the “step-up dosing schedule”, the treatment dose of LYNOZYFIC is usually given 1 time each week for 11 doses, and then 1 time every other week for 5 doses. After these doses and based on how your disease responds, your healthcare provider will decide if you are able to receive LYNOZYFIC less often (every 4 weeks) or will continue to have every other week treatment. Your healthcare provider will decide how long you will receive treatment with LYNOZYFIC. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with LYNOZYFIC. What should I avoid while receiving LYNOZYFIC?Do not drive, or operate heavy or potentially dangerous machinery, or do other dangerous activities for 48 hours after completing each of your “step-up” doses or at any time during treatment with LYNOZYFIC if you develop new neurologic symptoms, until the symptoms go away. What are the possible side effects of LYNOZYFIC?LYNOZYFIC may cause serious side effects, including: Infections. LYNOZYFIC can cause bacterial, viral, or fungal infections that are serious, life-threatening, or that may lead to death. Upper respiratory tract infections and pneumonia are common during treatment with LYNOZYFIC. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with LYNOZYFIC. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with LYNOZYFIC. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LYNOZYFIC, including: fever of 100.4 °F (38 °C) or higher chills cough shortness of breath chest pain sore throat pain during urination feeling weak or generally unwell Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with LYNOZYFIC and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts before you start treatment and during treatment with LYNOZYFIC, and will treat you as needed. Liver problems. LYNOZYFIC can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Your healthcare provider will do blood tests to check your liver before starting and during treatment with LYNOZYFIC. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems: tiredness loss of appetite pain in your right upper stomach-area (abdomen) dark urine yellowing of your skin or the white part of your eyes Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with LYNOZYFIC. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with LYNOZYFIC. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LYNOZYFIC, including: fever of 100.4 °F (38 °C) or higher chills cough shortness of breath chest pain sore throat pain during urination feeling weak or generally unwell fever of 100.4 °F (38 °C) or higher chills cough shortness of breath chest pain sore throat pain during urination feeling weak or generally unwell tiredness loss of appetite pain in your right upper stomach-area (abdomen) dark urine yellowing of your skin or the white part of your eyes The most common side effects of LYNOZYFIC include: muscle and bone pain cough diarrhea tiredness or weakness nausea headache shortness of breath The most common severe abnormal blood test results with LYNOZYFIC include: low white blood cell counts and low red blood cell counts. These are not all of the possible side effects of LYNOZYFIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for LYNOZYFIC. What is LYNOZYFIC?LYNOZYFIC is a prescription medicine used to treat adults with multiple myeloma who: have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and their cancer has come back or did not respond to prior treatment. It is not known if LYNOZYFIC is safe and effective in children. About Regeneron in Hematology At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. About Regeneron 's VelocImmune Technology Regeneron 's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron 's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized 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. 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 www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation the clinical programs evaluating Lynozyfic® (linvoseltamab) as a monotherapy or in various combination regimens discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Lynozyfic for the treatment of adults with relapsed or refractory systemic light chain amyloidosis as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Lynozyfic) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates; 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 Lynozyfic) 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, including in connection with Regeneron’s April 2026 agreements with the U.S. government; 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 and its Form 10-Q for the quarterly period ended March 31, 2026 . 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 (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Source: Regeneron Pharmaceuticals, Inc.

Dupixent showed significant and clinically meaningful improvements in both esophageal distensibility as well as disease-related structural changes and inflammation in the esophagus in adult patients with EoE at week 24 compared to placebo, in results presented at DDW These results reinforce the roles of IL-4 and IL-13, two of the key and central drivers of type 2 inflammation, in EoE EoE is a chronic, progressive disease that causes scarring and narrowing of the esophagus, making it difficult to swallow food, with more pronounced damage increasing the risk for severe symptoms TARRYTOWN, N.Y. and PARIS, May 05, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented results from the REMODEL Phase 4 trial demonstrating that Dupixent ® (dupilumab) showed significant and clinically meaningful improvements in both esophageal distensibility (a measure of esophageal function) as well as disease-related structural changes to the esophagus compared to placebo in adults with eosinophilic esophagitis (EoE) at week 24. The results reinforce the previously established ability of Dupixent to address underlying inflammation and symptoms of this disease; Dupixent was the first and is still the only biologic and leading treatment indicated for EoE. The new data were shared today in a late-breaking oral presentation at the 2026 Digestive Disease Week (DDW) conference. EoE is a chronic, progressive inflammatory disease associated with type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can lead to choking and become a painful and worrisome experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, and the esophagus can no longer distend to support normal swallowing, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube was historically the only available option to ensure proper caloric intake and adequate nutrition. However, Dupixent has dramatically changed the standard of care for this disease, improving quality of life for many patients. “For patients who have eosinophilic esophagitis, if the disease remains untreated, it can progress to narrowing of the esophagus, more severe symptoms, such as food impaction, and the need for esophageal dilation,” said Evan S. Dellon, M.D., M.P.H., Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and lead author of this study. “Dupixent showed a potential to modify the course of eosinophilic esophagitis – by improving esophageal size at just 6 months – the magnitude of this improvement corresponded to the benefit that could be seen from an esophageal dilation procedure. It also reduced hallmark endoscopic and histologic signs of disease, which further strengthens the evidence that type 2 inflammation plays an important role in the biology of this disease. The ongoing study will allow us to learn the even longer-term impact of Dupixent on the scarring and narrowing of the esophagus in EoE.” In the REMODEL Phase 4 trial, 69 adults with EoE were treated with Dupixent 300 mg (n=46) every week or placebo (n=23). At week 24, the results for Dupixent compared to placebo were: Improved esophageal distensibility (a measure of esophageal function) : 1.28 mm improvement in esophageal distensibility plateau from baseline compared to -0.01 mm (1.30 mm placebo-corrected improvement; p<0.05), the primary endpoint. This represents a 9% improvement from baseline compared to 1% (8% placebo-corrected improvement; p<0.05), the key secondary endpoint. The esophageal distensibility plateau measures the ability of the esophagus to expand and allow food to be transported through the esophagus effectively, with higher numbers representing better esophageal function and lower numbers representing worse function. Reduced disease-related structural changes to the esophagus : 4.89-point reduction from baseline in abnormal endoscopic findings, as assessed by EREFS (a scale ranging from 0-18), evaluating a combination of esophageal edema (swelling), rings (bands of scar tissue that narrow the esophagus), exudates (white plaques indicative of inflammation), furrows (vertical grooves indicative of damaged lining) and strictures (narrowing), compared to 0.07-point increase (4.96-point placebo-corrected reduction; p<0.0001). Improved histological findings : 0.89-point and 0.80-point reductions from baseline in disease severity and extent, respectively, as assessed by the EoE-HSS grade and stage scores (both scales ranging from 0-3), measuring changes in eight cellular and tissue features of biopsy specimens at the microscopic level, compared to 0.18-point and 0.14-point reductions, respectively (0.71-point and 0.65-point placebo-corrected reductions, respectively; p<0.0001 for both). Increased histological remission : 59% of patients achieved peak esophageal intraepithelial counts of ≤6 eosinophils per high-power field (eos/hpf) compared to 4% (p<0.0001). Additionally, 78% of patients achieved peak esophageal intraepithelial counts of <15 eos/hpf, the diagnostic threshold for EoE, compared to 4% (nominal p<0.0001). The safety results from the REMODEL trial were generally consistent with the known safety pro Dupixent in EoE. The overall rates of adverse events (AEs) were 62% for Dupixent and 48% for placebo. AEs more commonly observed with Dupixent than placebo included injection site pain (9% vs. 4%) and headache (9% vs. 4%). There were no serious AEs in either treatment group. About REMODEL The ongoing REMODEL Phase 4, randomized, double-blind, placebo-controlled trial is evaluating the impact of Dupixent on esophageal remodeling and function in adults with EoE. During the 24-week, double-blind treatment period, all patients received Dupixent 300 mg every week or placebo. After week 24, patients entered an open-label treatment period and could either continue Dupixent or switch from placebo to Dupixent through week 128. The primary endpoint assessed change from baseline at week 24 in esophageal distensibility plateau as measured by endoluminal functional lumen imaging probe (EndoFLIP), an innovative approach to assess esophageal function based on scarring and narrowing. Further assessments of esophageal distensibility are planned at week 76 and week 128 during the open-label treatment period. Esophageal distensibility plateau is reported in millimeters and represents how the esophagus expands in response to a small balloon being inflated at multiple points inside the esophagus. The distensibility plateau is the maximum esophageal diameter achieved at the narrowest point of the esophagus when further increases in balloon pressure do not meaningfully increase diameter. Higher numbers represent better esophageal function, and lower numbers represent worse function. Secondary endpoints assessed at week 24 included: Percent change from baseline in esophageal distensibility plateau as measured by EndoFLIP, the key secondary endpoint. Change from baseline in EoE Endoscopic Reference Score (EoE-EREFS) on a 0-18 scale. Change from baseline in EoE Histology Scoring System (EoE-HSS) grade and stage scores, which measure changes in eight cellular and tissue features on 0-3 scales, respectively. Proportion of patients achieving histological disease remission (peak esophageal intraepithelial eosinophil count of ≤6 eosinophils [eos]/high power field [hpf]). Proportion of patients achieving the diagnostic threshold for EoE (peak esophageal intraepithelial eosinophil count of <15 eos/hpf). About Dupixent 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), EoE, prurigo nodularis, chronic spontaneous urticaria (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 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 2 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 2 years of age, or who weigh less than 11 pounds (5 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 right away 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: 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 eosinophilic esophagitis; 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 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; 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, including in connection with Regeneron’s April 2026 agreements with the U.S. government; 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 and its Form 10-Q for the quarterly period ended March 31, 2026. 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 ( ). Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center. Regeneron Contacts: Media Relations Kailey Kilmartin Tel: +1 914-652-0679 Kailey.Kilmartin@regeneron.com Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com Sanofi Contacts: Media Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com L éo Le Bourhis Tel: + 33 6 75 06 43 81 leo.lebourhis@sanofi.com Victor Rouault Tel: +1 617-356-4751 Victor.Rouault@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com Léa Ubaldi Tel: +33 6 30 19 66 46 Lea.Ubaldi@sanofi.com Ekaterina Pesheva Tel: +1 410-926-6780 Ekaterina.Pesheva@sanofi.com Investor Relations Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Nina Goworek Tel : +1 908-569-7086 Nina.Goworek@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Yun Li Tel: +33 6 84 00 90 72 Yun.Li3@sanofi.com 1 Data on File