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Lynozyfic is a bispecific antibody directing T cells to kill multiple myeloma cancer cells; multiple myeloma is the second most common blood cancer Approval based on pivotal Phase 1/2 LINKER-MM1 trial; results reported were among the highest overall (70%) and complete response rates (45%) for bispecific antibodies in heavily pre-treated multiple myeloma patients Lynozyfic provides a patient-centric response-adapted dosing regimen TARRYTOWN, NY, USA I July 02, 2025 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes hospitalization for safety during the step-up dosing period (one 24-hour period after the first step-up dose, and another 24-hour period after the second step-up dose). “The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials,” said Sundar Jagannath, M.D., Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator. “Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden.” The FDA approval is based on results from the pivotal Phase 1/2 LINKER-MM1 trial investigating linvoseltamab in R/R MM in which patients (n=80) experienced a: The prescribing information for Lynozyfic has a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. The most common adverse reactions (≥20%) in the safety population of LINKER-MM1 (n=117) were musculoskeletal pain, CRS, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin and decreased white blood cell count. Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS). Details of the Important Safety Information are included below. “The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. “With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma. Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients.” Regeneron is committed to helping patients who have been prescribed Lynozyfic access their medication. The company has launched Lynozyfic Surround™, which offers financial and educational resources to help support patients throughout their treatment journey. For more information, patients can call 1-844-RGN-HEME (1-844-746-4363). “Even though the number of treatment options for multiple myeloma has expanded in recent years, it remains an incurable disease with considerable unmet need, especially among patients who have undergone multiple lines of treatment,” said Diane Moran, R.N., M.A., Ed.M., Chief Executive Officer (Interim) and Senior Vice President of Strategic Planning at the International Myeloma Foundation. “The FDA approval of Lynozyfic is a welcome milestone. It provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron’s continued research to further advance treatment for this community.” About Multiple Myeloma As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies. About Lynozyfic™ (linvoseltamab-gcpt) 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. Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. At week 14, patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve and maintain a VGPR or better after having completed at least 24 weeks of therapy. Patients should be hospitalized for 24 hours after administration of the first step-up dose and for 24 hours after administration of the second step-up dose, with the potential for additional hospitalization if patients experience certain adverse events. The generic name for Lynozyfic in its approved U.S. indication is linvoseltamab-gcpt with gcpt as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name of Lynozyfic in its approved indications is linvoseltamab. Lynozyfic is also approved in the European Union to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu in due course. About the Linvoseltamab Clinical Development Program The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in more than 300 enrolled patients with R/R MM. The Phase 1 intravenous dose-escalation portion of the trial – which is now complete – primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. A subcutaneous Phase 1 portion is ongoing. The Phase 2 intravenous dose expansion portion is ongoing and assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of ORR. Key secondary endpoints include DoR, progression-free survival, rate of minimum residual disease negative status and overall survival. 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. This includes evaluating linvoseltamab in a Phase 1b trial ( LINKER-MM2 ) in combination with other cancer treatments in R/R MM as well as a Phase 3 confirmatory trial ( LINKER-MM3 ) as a monotherapy in R/R MM. 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 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 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. 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: It is not known if LYNOZYFIC is safe and effective in children. 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 . SOURCE: Regeneron Pharmaceuticals

TEL AVIV, Israel, June 9, 2025 /PRNewswire/ -- Microtech, a wholly owned subsidiary of Medinol, is happy to announce the first U.S. implantations of its atrial-pressure microsensor. Two surgical implantations were performed on Friday, May 16, 2025, at New York-Presbyterian/Columbia University Irving Medical Center by Dr. Koji Takeda, Surgical Director for Adult Heart Transplant at New York-Presbyterian/Columbia. The Microtech atrial-pressure microsensor is a new class of device, characterized by an extremely small size, entirely passive nature, the absence of any electronics or antenna and its ability to receive and transmit signals via ultrasound. Due to these properties, the Microtech sensors can be used not only as a stand-alone device but can also be integrated onto existing implants, turning them into combination therapeutic-diagnostic smart devices, capable of gathering data and performing multiple functions at once. The two sensors, implanted in patients who received LVADs at New York-Presbyterian/Columbia, join the 5 microsensors already implanted in Israel under similar conditions. "Implantation of the microsensor was easy and took about 5 minutes, requiring a minimal modification to the LVAD implantation procedure," Dr. Takeda said. "The ability to non-invasively monitor both left and right-sided cardiac pressures over time will significantly enhance our ability to optimize care for these patients, allowing us to move past symptoms to parameter-based therapy," said Dr. Nir Uriel, Director of Advanced Heart Failure and Cardiac Transplantation at NewYork-Presbyterian and PI of the Microtech FIH study, adding that, "So far, we've been able to easily, repeatedly and accurately measure these pressures in all patients participating in the study." Dr. Uriel is also an adjunct professor of medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine and a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons. The Microtech FIH study is scheduled to enroll approximately 15 patients in Israel and the U.S. Dr. Yoram Richter, CEO of Medinol, said: "We are thrilled with the study progress and sensor performance thus far and hope that these will continue, allowing us to demonstrate the feasibility, usability and accuracy of this system. Simultaneously, we are working on incorporating microsensors onto existing medical devices, fulfilling the true promise of this technology." About Medinol At Medinol, we are aggressively changing paradigms in how disease states are diagnosed and treated. Whether designing cutting edge devices for stenting multiple areas of the body, dramatically reducing complications in Structural Heart procedures or providing real time insights into the physiological metrics of the human body through implantable sensors, we boldly reassess current technology and procedures and look years into the future to pioneer new devices to broaden the reach of physicians both physically and geographically. Working with our physician and industry partners, Medinol is creating the future today. For more information see or contact Jeff Roach, Chief Commercial Officer at [email protected]. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

1 Columbia University Medical Center New York, New York 2 Brigham and Women's Hospital Boston, Massachusetts 8 University of Kansas Medical Center Kansas City, Kansas 10 University of Pennsylvania Philadelphia, Pennsylvania 11 University of Virginia Health System Charlottesville, Virginia 13 Vanderbilt University Medical Center Nashville, Tennessee 14 Indiana University Medical Center Indianapolis, Indiana 17 Mayo Clinic Rochester, Minnesota 18 National Institutes of Health Bethesda, Maryland 20 Stanford University School of Medicine Stanford, California 25 The State University of New York at Buffalo Buffalo, New York 28 VA San Diego Healthcare System San Diego, California 32 Massachusetts General Hospital Boston, Massachusetts 33 University of Maryland Medical System Baltimore, Maryland 36 University of Southern California Los Angeles, California 37 Temple University Philadelphia, Pennsylvania 38 Ernest Orlando Lawrence Berkeley National Laboratory Berkeley, California 40 Emory University Atlanta, Georgia 41 University of California, Los Angeles - UCLA Los Angeles, California 42 Johns Hopkins Medical Institutions Baltimore, Maryland 44 The University of Texas Southwestern Medical Center Dallas, Texas 45 The University of Michigan Medical School Ann Arbor, Michigan 46 University of Texas Medical Branch Galveston, Texas 47 University of California, San Diego San Diego, California 48 The University of Iowa Iowa City, Iowa 51 The Methodist Hospital DBA (doing business as) "Houston Methodist" Houston, Texas 56 University of Texas Health Science Center at San Antonio San Antonio, Texas 59 Loma Linda University Medical Center Loma Linda, California 62 VA Greater Los Angeles Healthcare System Los Angeles, California 63 University of Alabama at Birmingham Birmingham, Alabama 70 Thomas Jefferson University Philadelphia, Pennsylvania 71 University of California, San Francisco San Francisco, California 78 University of Utah Salt Lake City, Utah 91 University of Wisconsin School of Medicine and Public Health Madison, Wisconsin 92 University of California - Davis Medical Center Sacramento, California 101 NYU Langone Health New York, New York 103 North Shore University Hospital Manhasset, New York 105 Memorial Sloan-Kettering Cancer Center New York, New York 122 Washington University School of Medicine St. Louis, Missouri 125 Corewell Health (formally Beaumont Health) Royal Oak, Michigan 135 University of Colorado Anschutz Medical Campus Aurora, Colorado 145 University of Minnesota Minneapolis, Minnesota 160 State University of New York at Stony Brook Stony Brook, New York 161 University of Pittsburgh Pittsburgh, Pennsylvania 170 University of Tennessee Medical Center Knoxville, Tennessee 175 Wake Forest University Health Sciences Winston Salem, North Carolina 179 Louisiana State University Health Sciences Center in Shreveport Shreveport, Louisiana 184 The University of Washington Seattle, Washington 185 West Virginia University Hospitals Inc. Morgantown, West Virginia 186 Karmanos Cancer Institute (KCI) Detroit, Michigan 201 Banner University Medical Center - Phoenix (BUMCP)/ Banner Alzheimer's Institute (BAI) Phoenix, Arizona 202 University of North Carolina at Chapel Hill Chapel Hill, North Carolina 203 Tennessee Valley Healthcare System (Nashville VA Medical Center) Nashville, Tennessee 206 Yale University New Haven, Connecticut 207 Medical College of Wisconsin Milwaukee, Wisconsin 208 BAMF (Bold Advanced Medical Future) Health Grand Rapids, Michigan Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.