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    Regeneron Highlights Progress at American Society of Hematology (ASH), with Updated Data in Multiple Myeloma, Lymphoma and Paroxysmal Nocturnal Hemoglobinuria Programs

    11/13/25 7:00:00 AM ET
    $REGN
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $REGN alert in real time by email

    Oral presentation of Lynozyfic™ (linvoseltamab-gcpt) data in newly diagnosed multiple myeloma from LINKER-MM4, the first trial to evaluate a BCMAxCD3 bispecific antibody as a monotherapy in this setting

    Additional oral presentation spotlights data for odronextamab in combination with chemotherapy, without rituximab, as a frontline treatment for diffuse large B-cell lymphoma

    Other presentations span a broad range of hematologic conditions, including paroxysmal nocturnal hemoglobinuria and severe aplastic anemia

    Regeneron to host virtual ‘Regeneron Roundtable' investor event to discuss its multiple myeloma development program on Wednesday, December 10 at 8:30 a.m. ET

    TARRYTOWN, N.Y., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced new and updated data from its hematology portfolio and pipeline will be shared across 14 abstracts at the American Society of Hematology (ASH) 2025 Annual Meeting, taking place from December 6-9 in Orlando, FL. Presentations highlight the next wave of potential novel approaches across a range of blood cancers and disorders.

    "This has been a landmark year for our Hematology program with U.S. and international regulatory approvals and launches for our blood cancer medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "At ASH, our momentum continues with oral presentations on Lynozyfic as well as odronextamab in the frontline setting, which showcase how earlier interventions with our innovative approaches have the potential to benefit even more patients. We will also share updated results across our blood disorders pipeline, which reinforce our strategy of translating our deep expertise in hematology into meaningful progress where unmet needs remain."

    Notable presentations from the Lynozyfic™ (linvoseltamab-gcpt) development program include an oral presentation on the Phase 1/2 LINKER-MM4 trial, which is the first to investigate the use of a bispecific monotherapy in newly diagnosed multiple myeloma (MM). New results will also be shared from the multicohort Phase 1b LINKER-MM2 trial evaluating linvoseltamab with two different anti-CD38 monoclonal antibodies in patients with relapsed/refractory (R/R) MM.

    Progress on the odronextamab development program will be featured in six abstracts including an oral presentation on the first results of odronextamab plus chemotherapy from OLYMPIA-3 in previously untreated diffuse large B-cell lymphoma (DLBCL). Other presentations include the first results from Part 1 of two Phase 3 trials evaluating odronextamab in follicular lymphoma (FL) – odronextamab plus chemotherapy in frontline FL (OLYMPIA-2) as well as odronextamab plus lenalidomide in R/R FL (OLYMPIA-5).

    Additional presentations include updated results for the novel combination of cemdisiran with pozelimab (cemdi-poze) compared to ravulizumab in paroxysmal nocturnal hemoglobinuria as well as the first-in-human evaluation of REGN7257 in severe aplastic anemia.

    The full list of Regeneron presentations at ASH includes: 

    Abstract TitlePresentation IDPresenterSession Date/Time (ET)
    Lynozyfic
    Safety and efficacy of linvoseltamab as a simplified monotherapy first-line regimen in NDMM: Initial Results from the window of opportunity Phase 1/2 LINKER-MM4 trial​#697



    Oral Presentation Session 654
    Robert OrlowskiSunday,

    December 7 at 4:30 – 6:00 pm



    West Hall E1
    Safety and efficacy of linvoseltamab (LINVO) combined with anti-CD38 monoclonal antibodies (mAbs) daratumumab (DARA) or isatuximab (ISA) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the multicohort, Phase 1b LINKER-MM2 trial

    #2254



    Poster Session 654
    Meletios DimopoulosSaturday,

    December 6 at 5:30 – 7:30 pm



    West Halls B3-B4
    Odronextamab
    Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study#65



    Oral Presentation

    Session 629

    Jean-Marie MichotSaturday, December 6 at 9:30 – 11:00 am



    Tangerine Ballroom F2
    Efficacy and safety of long-term odronextamab treatment in patients with relapsed/refractory follicular lymphoma: 3-year follow-up from the Phase 2 ELM-2 study#3588



    Poster Session 623



    Jose Villasboas BisnetoSunday, December 7

    at 6:00 – 8:00 pm



    West Halls B3-B4
    Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study#3600



    Poster

    Session 623

    Kitsada WudhikarnSunday, December 7

    at 6:00 – 8:00 pm



    West Halls B3-B4
    Odronextamab (Odro) plus lenalidomide (+Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): First results from part 1 (safety lead-in) of the Phase 3 OLYMPIA-5 study#5381



    Poster

    Session 623
    Umberto VitoloMonday, December 8 at 6:00 – 8:00 pm



    West Halls B3-B4
    Phased variant circulating tumor DNA (ctDNA) tracking provides limited additional power in predicting progressive disease compared with duplex variant tracking in patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) treated with odronextamab#5309



    Poster Session 621
    Jon ArnasonMonday,

    December 8 at 6:00 – 8:00 pm



    West Halls B3-B4
    Odronextamab treatment for patients with rare subtypes of relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL): Updated efficacy and safety analyses from a dedicated cohort of the ELM-2 study#5523



    Poster

    Session 629



    Farrukh AwanMonday,

    December 8 at 6:00 – 8:00 pm



    West Halls B3-B4
    Cemdisiran and Pozelimab ("cemdi-poze")*
    Efficacy and safety of pozelimab plus cemdisiran versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria who received prior C5 therapy#1420



    Poster Session 508
    Jun Ho JangSaturday,

    December 6 at

    5:30 – 7:30 pm



    West Halls B3-B4
    Study design of A phase 3, open-label trial for pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria with inadequate control of intravascular hemolysis#4988



    Poster Session 508
    Jun Ho JangMonday,

    December 8 at 6:00 – 8:00 pm



    West Halls B3-B4
    REGN7257
    First-in-human evaluation of IL2RG blockade in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy#27



    Oral Presentation

    Session 508



    Regis Peffault De LatourSaturday,

    December 6 at

    9:30 – 11:00 am



    Hyatt - Plaza Int'l HIJK

    Multiple Myeloma
    Health care resource utilization in patients with multiple myeloma receiving bispecific antibody therapy with teclistamab: A Medicare claims database analysis in the US#3975



    Poster

    Session 653
    Sikander AilawadhiSunday,

    December 7 at 6:00 – 8:00 pm



    West Halls B3-B4
    Aplastic Anemia
    Comprehensive multiproteomic analysis reveals an inflammatory phenotype in immune aplastic anemia characterized by broad activation of antigen presenting cells and t helper/cytotoxic 1.17 immune responses#3190



    Poster Session 508
    Audrey Le Floch-RamondouSunday, December 7 at 6:00 – 8:00 pm



    West Halls B3-B4



    Longitudinal multiproteomic analysis reveals persistent underlying inflammation in acute graft-versus-host disease patients responding to corticosteroid treatment#2456



    Poster Session 722
    Audrey Le Floch-RamondouSaturday, December 6 at

    5:30 – 7:30 pm



    West Halls B3-B4

     *Agreement with Alnylam Pharmaceuticals, Inc.

    Cemdi-poze as well as REGN7257 are investigational, and the uses of linvoseltamab described above and of odronextamab in rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono® for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority.

    About the ‘Regeneron Roundtable' Investor Event

    Regeneron will host a virtual investor event to discuss its multiple myeloma program on Wednesday, December 10 at 8:30 a.m. ET. This is the next webcast in a new investor event series called the 'Regeneron Roundtable,' intended to highlight programs from the company's innovative investigational pipeline.

    Links to the webcast and to register via telephone may be accessed from the ‘Investors and Media' page of Regeneron's website at https://investor.regeneron.com/events-and-presentations. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

    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 Lynozyfic

    Lynozyfic was invented using Regeneron's VelocImmune® technology and is a fully human BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (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.

    Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as MM precursor and other plasma cell disorders. For more information on Regeneron's clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 1-844-734-6643.

    About Odronextamab

    Odronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. Odronextamab is approved in the European Union as Ordspono® for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy.

    Regeneron is conducting a broad Phase 3 development program, known as OLYMPIA, investigating odronextamab in earlier lines of therapy and other B-cell non-Hodgkin lymphomas. For more information on Regeneron's clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 1-844-734-6643.

    LYNOZYFIC IMPORTANT SAFETY INFORMATION

    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•  fast heartbeat
    •  chills or shaking•  dizziness or light-headedness
    •  trouble breathing 



    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.

    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.

    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 

    The most common side effects of LYNOZYFIC include:

    •  muscle and bone pain•  nausea
    •  cough•  headache
    •  diarrhea•  shortness of breath
    •  tiredness or weakness 



    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'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, 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 Lynozyfic™ (linvoseltamab-gcpt), odronextamab, and the other programs discussed or referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates (such as those referenced above); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as the programs discussed or referenced in this press release; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron's pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); 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, 2024 and its Form 10-Q for the quarterly period ended September 30, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

    Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

    Contacts:

     
      
    Media Relations

    Tammy Allen

    Tel: +1 914-306-2698

    [email protected]

    Investor Relations

    Mark Hudson

    Tel: +1 914-847-3482

    [email protected]

      


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    10-Q - REGENERON PHARMACEUTICALS, INC. (0000872589) (Filer)

    10/28/25 6:56:36 AM ET
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    Regeneron Pharmaceuticals Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

    8-K - REGENERON PHARMACEUTICALS, INC. (0000872589) (Filer)

    10/28/25 6:50:40 AM ET
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    $REGN
    Analyst Ratings

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    Rothschild & Co Redburn initiated coverage on Regeneron Pharma with a new price target

    Rothschild & Co Redburn initiated coverage of Regeneron Pharma with a rating of Buy and set a new price target of $890.00

    8/14/25 8:22:44 AM ET
    $REGN
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    Regeneron Pharma downgraded by Argus

    Argus downgraded Regeneron Pharma from Buy to Hold

    6/30/25 8:42:52 AM ET
    $REGN
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    Regeneron Pharma downgraded by RBC Capital Mkts with a new price target

    RBC Capital Mkts downgraded Regeneron Pharma from Outperform to Sector Perform and set a new price target of $662.00

    5/30/25 12:22:00 PM ET
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    Regeneron Highlights Progress at American Society of Hematology (ASH), with Updated Data in Multiple Myeloma, Lymphoma and Paroxysmal Nocturnal Hemoglobinuria Programs

    Oral presentation of Lynozyfic™ (linvoseltamab-gcpt) data in newly diagnosed multiple myeloma from LINKER-MM4, the first trial to evaluate a BCMAxCD3 bispecific antibody as a monotherapy in this setting Additional oral presentation spotlights data for odronextamab in combination with chemotherapy, without rituximab, as a frontline treatment for diffuse large B-cell lymphoma Other presentations span a broad range of hematologic conditions, including paroxysmal nocturnal hemoglobinuria and severe aplastic anemia Regeneron to host virtual ‘Regeneron Roundtable' investor event to discuss its multiple myeloma development program on Wednesday, December 10 at 8:30 a.m. ET TARRYTOWN, N.Y., Nov.

    11/13/25 7:00:00 AM ET
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    Phase 2 Trials Demonstrating Antithrombotic Effect of Two Novel Regeneron Factor XI Antibodies Presented at American Heart Association Scientific Sessions and Published in The Lancet

    Proof-of-concept trials confirm robust anti-clotting effects for Regeneron's two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement Trial results consistent with prospective design of these antibodies to have distinct profiles – one to provide stronger anticoagulation and the other to have a lower risk of bleeding – potentially allowing physicians to tailor anticoagulant therapy for patients with different risk profiles Phase 3 trials in patients undergoing total knee replacement initiated as part of broad factor XI program evaluating the two antibodies across a range of patient populations and clinical settings Regeneron to host vir

    11/8/25 10:46:31 AM ET
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    Press Release: ACAAI: Sanofi and Regeneron's Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review

    ACAAI: Sanofi and Regeneron's Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion, and nasal polyps in patients aged 6 years and older compared to placeboDupixent sBLA accepted for priority review by the US FDA with a target action date of February 28, 2026; if approved, Dupixent would be the first and only medicine indicated specifically for AFRS, which would be its ninth FDA-approved indicationAFRS is a chronic type 2 inf

    11/7/25 8:00:00 AM ET
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    $REGN
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    VP Controller Pitofsky Jason sold $280,766 worth of shares (431 units at $651.43), decreasing direct ownership by 9% to 4,233 units (SEC Form 4)

    4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

    11/10/25 4:37:37 PM ET
    $REGN
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    Director Poon Christine A exercised 9,212 shares at a strike of $520.01 and sold $4,252,745 worth of shares (6,500 units at $654.27), increasing direct ownership by 115% to 5,064 units (SEC Form 4)

    4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

    10/31/25 4:09:02 PM ET
    $REGN
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    EVP Research Murphy Andrew J exercised 35,000 shares at a strike of $555.67, covered exercise/tax liability with 32,490 shares and gifted 1,538 shares, increasing direct ownership by 2% to 50,046 units (SEC Form 4)

    4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

    10/31/25 4:06:57 PM ET
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    May 20, 2022 - FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

    For Immediate Release: May 20, 2022 Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). Today’s action marks the first FDA approval of a treatment for EoE. “As researchers and clinicians have gained knowledge about eosinophilic esophagitis

    5/20/22 3:11:09 PM ET
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    $REGN
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    SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

    SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

    2/13/24 5:12:22 PM ET
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    SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

    SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

    2/9/24 6:19:03 PM ET
    $REGN
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    SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

    SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

    2/9/24 9:49:31 AM ET
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    Regeneron Highlights Progress at American Society of Hematology (ASH), with Updated Data in Multiple Myeloma, Lymphoma and Paroxysmal Nocturnal Hemoglobinuria Programs

    Oral presentation of Lynozyfic™ (linvoseltamab-gcpt) data in newly diagnosed multiple myeloma from LINKER-MM4, the first trial to evaluate a BCMAxCD3 bispecific antibody as a monotherapy in this setting Additional oral presentation spotlights data for odronextamab in combination with chemotherapy, without rituximab, as a frontline treatment for diffuse large B-cell lymphoma Other presentations span a broad range of hematologic conditions, including paroxysmal nocturnal hemoglobinuria and severe aplastic anemia Regeneron to host virtual ‘Regeneron Roundtable' investor event to discuss its multiple myeloma development program on Wednesday, December 10 at 8:30 a.m. ET TARRYTOWN, N.Y., Nov.

    11/13/25 7:00:00 AM ET
    $REGN
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Phase 2 Trials Demonstrating Antithrombotic Effect of Two Novel Regeneron Factor XI Antibodies Presented at American Heart Association Scientific Sessions and Published in The Lancet

    Proof-of-concept trials confirm robust anti-clotting effects for Regeneron's two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement Trial results consistent with prospective design of these antibodies to have distinct profiles – one to provide stronger anticoagulation and the other to have a lower risk of bleeding – potentially allowing physicians to tailor anticoagulant therapy for patients with different risk profiles Phase 3 trials in patients undergoing total knee replacement initiated as part of broad factor XI program evaluating the two antibodies across a range of patient populations and clinical settings Regeneron to host vir

    11/8/25 10:46:31 AM ET
    $REGN
    Biotechnology: Pharmaceutical Preparations
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    Regeneron to Report Third Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on October 28, 2025

    TARRYTOWN, N.Y., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2025 financial and operating results on Tuesday, October 28, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the 'Investors and Media' page of Regeneron's website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email det

    9/30/25 4:05:00 PM ET
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    $REGN
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    Regeneron Announces First-of-its-Kind Donation Matching Program with Independent Charitable Patient Assistance Organization

    TARRYTOWN, N.Y., June 24, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced the launch of a pioneering matching program for donations to Good Days, an independent national non-profit charitable organization, to support Good Days' Retinal Vascular and Neovascular Disease Fund. Through this initiative, Regeneron has committed to matching donations up to a total of $200 million at a one-to-one rate for the remainder of the 2025 calendar year, enabling more patients to affordably access essential medicines that help protect their vision. "We are proud to support Good Days with this unprecedented philanthropic effort," said Leonard Schleifer, M.D., Ph.D.,

    6/24/25 7:30:00 AM ET
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    Regeneron Announces Formation of Regeneron Cell Medicines with the Acquisition of 2seventy bio Platforms and Preclinical and Clinical Programs

    TARRYTOWN, N.Y., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization rights to its pipeline of investigational novel immune cell therapies, along with its discovery and clinical manufacturing capabilities. 2seventy bio employees who support the acquired programs will join Regeneron Cell Medicines, a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology. "Regeneron and 2seventy share a relentless commitment to push the boundaries of scie

    1/30/24 7:00:41 AM ET
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    Together for CHANGE Genomics and Equity Initiative Launched by a Coalition of Meharry Medical College, Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to Improve Health Outcomes for People of African Ancestry

    NIH data show that globally less than 2% of genetic information being studied today originates from people of African ancestry1 The newly established Diaspora Human Genomics Institute (DHGI) will manage the Together for CHANGE initiative, which aims to increase available genomic data for people of African ancestry and enhance representation in STEM careers NASHVILLE, Tenn. and TARRYTOWN, N.Y. and WILMINGTON, Del. and BAGSVAERD, Denmark and BASEL, Switzerland, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Meharry Medical College, along with partners Regeneron Genetics Center® (RGC™), AstraZeneca, Novo Nordisk, and Roche, today announced the launch of the Together for CHANGE™ ("Changing Healthcare for

    10/18/23 9:00:00 AM ET
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