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:
*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 clinicaltrials@regeneron.com or 1-844-734-6643.
About OdronextamabOdronextamab 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 clinicaltrials@regeneron.com 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:
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.
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.
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
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
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
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:
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).
Source: Regeneron Pharmaceuticals, Inc.
