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Last update 26 Dec 2025

Lisocabtagene maraleucel

Last update 26 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-directed chimeric antigen receptor T cell therapy

+ [7]

Target

CD19

Action

modulators

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Marginal zone lymphoma recurrentRefractory Marginal Zone LymphomaMantle cell lymphoma recurrent+ [27]

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaPrecursor B-Cell Lymphoblastic Leukemia-LymphomaRefractory Aggressive Non-Hodgkin Lymphoma+ [2]

Originator Organization

Fred Hutchinson Cancer Research Center

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.Bristol-Myers Squibb Pharma EEIG

Juno Therapeutics, Inc.

+ [3]

Inactive Organization-

License Organization

Fred Hutchinson Cancer Research Center

Juno Therapeutics, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (05 Feb 2021),

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh grade B-cell lymphoma+ [1]

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)

Structure/Sequence

Sequence Code 133531

Source: *****

Sequence Code 133534

Source: *****

Sequence Code 133555

Source: *****

Sequence Code 133567

Source: *****

Sequence Code 133586

Source: *****

Sequence Code 171111

Source: *****

Clinical Trials associated with Lisocabtagene maraleucel

NCT07098364

/ RecruitingPhase 1/2IIT

A Phase 1/2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.

Start Date08 Jan 2026

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT07194980

/ Not yet recruitingPhase 2IIT

Safety and Efficacy of the Addition of Nemtabrutinib to Lisocabtagene Maraleucel in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.

Start Date01 Dec 2025

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT07015242

/ RecruitingPhase 2

The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

Start Date06 Nov 2025

Sponsor / Collaborator

Juno Therapeutics, Inc.

100 Clinical Results associated with Lisocabtagene maraleucel

100 Translational Medicine associated with Lisocabtagene maraleucel

100 Patents (Medical) associated with Lisocabtagene maraleucel

196

Literatures (Medical) associated with Lisocabtagene maraleucel

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

11 Nov 2025·Blood Advances

Comparative real-world outcomes of CD19-directed CAR T-cell therapies in large B-cell lymphoma

Article

Author: Lin, Richard ; Ballweg, Annamaria ; Shah, Gunjan L. ; Rivas Delgado, Alfredo ; Lue, Jennifer ; Rabinovich, Emma ; Beyar-Katz, Ofrat ; Deschênes-Simard, Xavier ; Avigdor, Abraham ; Ip, Andrew ; Gonen, Mithat ; Corona De Lapuerta, Magdalena ; Devlin, Sean M. ; Luna De Abia, Alejandro ; Shouval, Roni ; Alhomoud, Mohammad ; Salles, Gilles ; Palomba, Maria Lia ; Falchi, Lorenzo ; Scordo, Michael ; Boardman, Alexander P. ; Dahi, Parastoo B. ; Perales, Miguel-Angel ; Marcus, Ronit ; Bromberg, Maria

Abstract:

Although 3 commercial CD19-targeted chimeric antigen receptor (CAR) T-cell therapies are available for large B-cell lymphomas (LBCLs), no randomized clinical trials have compared their efficacy and safety. In this retrospective multicenter cohort study, we evaluated real-world clinical outcomes of patients with relapsed/refractory LBCL treated with axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel). Between April 2016 and July 2024, 624 patients received CD19-targeted CAR T-cell therapies (344 axi-cel, 142 tisa-cel, and 138 liso-cel). At a median follow-up of 20.9 months, the respective estimated 2-year progression-free survival (PFS) and overall survival (OS) rates were 46% and 63% for axi-cel, 30% and 45% for tisa-cel, and 45% and 58% for liso-cel. After adjusting for potential confounders in multivariate analyses, tisa-cel was associated with inferior PFS and OS compared to axi-cel. No significant survival differences were found between liso-cel and axi-cel. Propensity score and subanalyses of patients treated in the second-line vs third-line or later settings yielded similar outcomes. Compared to axi-cel, the objective response rate at 100 days was higher for liso-cel and lower for tisa-cel. Rates of cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, and immune effector cell–associated hematotoxicity, and febrile neutropenia were significantly higher with axi-cel. However, no significant differences in the cumulative incidence of infections or nonrelapse mortality were found. Axi-cel was associated with faster vein-to-vein time (axi-cel, 35 days; tisa-cel, 43 days; liso-cel, 41 days) and fewer out-of-specification products (axi-cel, 2%; tisa-cel, 4%; liso-cel, 11%). These results provide insights into potential differential outcomes depending on product selection.

02 Nov 2025·Expert Opinion on Drug Discovery

The discovery and development of tisagenlecleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma

Review

Author: Maziarz, Richard T ; Kungwankiattichai, Smith

INTRODUCTION:

Follicular lymphoma (FL) is an indolent yet incurable subtype of non-Hodgkin lymphoma characterized by repeated relapses and diminishing responses with each treatment line. Although front-line chemoimmunotherapy achieves high initial response rates, a subset of patients - particularly those with early relapse (POD24) - experience poor outcomes and require alternative therapies. Tisagenlecleucel (tisa-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has emerged as a promising option for relapsed or refractory (r/r) FL, offering the potential for deep and durable remissions.

AREAS COVERED:

This review covers the scientific rationale, preclinical innovations, and clinical development of tisa-cel, from its origins in 2^nd-generation CAR-T engineering to its pivotal trials in hematologic malignancies. It is based on a literature search using PubMed, Embase, and conference abstracts from major hematology meetings from 1987 to April 2025. The paper deta ils the ELARA trial outcomes, subsequent long-term and real-world data, and the competitive landscape of third-line therapies for r/r FL.

EXPERT OPINION:

Tisa-cel has demonstrated high response rates and sustained remissions with a favorable safety profile in heavily pretreated FL, including high-risk populations such as those with POD24. While bispecific antibodies offer convenient outpatient administration, CAR-T cell therapy provides the potential for deep and durable remissions. The 4-1BB costimulatory domain used in tisa-cel and liso-cel is associated with a lower incidence of severe CRS and ICANS compared to CD28-based constructs. the field evolves, careful patient selection and head-to-head trials will be essential to refine therapeutic sequencing in r/r FL.

388

News (Medical) associated with Lisocabtagene maraleucel

19 Dec 2025

·www.prnewswire.com

Immunotherapies Replacing Chemotherapy as Blood Cancer Market to Hit $13B by 2030

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Dec. 19, 2025 /PRNewswire/ -- USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2]. These breakthroughs position companies like GT Biopharma, Inc. (NASDAQ: GTBP), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Genmab A/S (NASDAQ: GMAB), Autolus Therapeutics plc (NASDAQ: AUTL), and Lyell Immunopharma, Inc. (NASDAQ: LYEL). Market forecasters project the CAR-T cell therapy market will surge from $3.87 billion in 2024 to $13.25 billion by 2030, driven by unprecedented efficacy in relapsed and refractory patient populations[3]. GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The company specializes in developing next-generation immunotherapy treatments targeting some of the world's most resistant cancer types through its proprietary natural killer cell engager TriKE platform. GT Biopharma's Phase 1 dose escalation trial evaluates GTB-3650 in patients facing relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These cancers represent exceptionally challenging cases where conventional treatments have either failed completely or provided only temporary benefit before disease returned. The therapy harnesses the patient's natural killer cells, an immune cell type that instinctively identifies and eliminates abnormal cells, directing them to attack cancer specifically. Treatment delivery follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, with cycles continuing up to four months depending on individual patient response. "We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026." The six patients enrolled throughout Cohorts 1, 2, and 3 have completed GTB-3650 treatment successfully, establishing the therapy's safety profile across escalating dose concentrations. GT Biopharma indicates the current Cohort 4 dose of 10μg/kg/day represents a threshold where clinical efficacy becomes more likely, supported by encouraging immunological biomarker trends and zero dose-limiting toxicities across all completed cohorts. The first-in-human Phase 1 protocol plans for approximately 14 patients distributed across seven cohorts, with each cohort enrolling two patients at progressively increasing doses starting from 1.25μg/kg/day in Cohort 1 and potentially reaching 100μg/kg/day in Cohort 7 if warranted. Following Cohort 4, three additional escalation levels remain: Cohort 5 testing 25μg/kg/day, Cohort 6 evaluating 50μg/kg/day, and Cohort 7 examining the maximum protocol dose of 100μg/kg/day. The company anticipates providing its next comprehensive trial update during first quarter 2026. Beyond hematologic malignancies, GT Biopharma is advancing GTB-5550, targeting B7H3, a protein prevalent across multiple solid tumor categories including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. Regulatory submission to initiate GTB-5550 human trials is expected in late December 2025 or January 2026. Designed as a subcutaneous injection, GTB-5550 offers the potential for eventual self-administration at home, significantly reducing patient burden. Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas. These molecules provide distinct advantages compared to traditional antibodies through their compact size and enhanced stability. GT Biopharma maintains exclusive worldwide licensing rights from the University of Minnesota for this technology. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented data from the Phase 1/2 LINKER-MM4 trial showing Lynozyfic monotherapy achieved very good partial response or better of ≥70% across all three dose groups in newly diagnosed multiple myeloma patients despite limited follow-up. The first-ever BCMAxCD3 bispecific monotherapy trial in this setting demonstrated that 95% of evaluable responders achieved minimal residual disease negative status at 10⁻⁵ sensitivity. "Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens but earlier in the treatment course, and these compelling results are expected to deepen with longer follow up," said Robert Orlowski, M.D., Ph.D., Deputy Chair, Professor of Medicine, and Director of Translational Myeloma Research in the Departments of Lymphoma/Myeloma and Experimental Therapeutics at The University of Texas MD Anderson Cancer Center and the lead investigator for the LINKER-MM4 trial. "These results underscore Lynozyfic's potential as a foundational component of frontline treatment regimens for multiple myeloma – or even a monotherapy regimen – for both transplant-eligible and transplant-ineligible patients." The broad clinical development program includes ongoing Phase 2 expansion at the recommended 200mg dose and the LINKER-MM6 trial evaluating combination therapy in transplant-ineligible newly diagnosed patients. Regeneron will host a virtual Regeneron Roundtable investor event on December 10 to discuss its multiple myeloma development program. Genmab A/S (NASDAQ: GMAB) announced new data from its Phase 1b/2 EPCORE CLL-1 trial demonstrating epcoritamab's effectiveness as both monotherapy and in combination regimens for patients with Richter transformation, a rare and aggressive evolution of chronic lymphocytic leukemia. In first-line monotherapy, patients achieved a 57% overall response rate with 52% complete response, while 95% of evaluable responders achieved minimal residual disease negative status across all dose groups. "The results from these trials demonstrate the potential of epcoritamab as a monotherapy, and in combination, in patients with Richter transformation, a rare, often fatal, transformation of chronic lymphocytic leukemia into an aggressive lymphoma, mostly diffuse large B-cell lymphoma," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are deeply committed to exploring epcoritamab as a potential core therapy across a range of B-cell malignancies, both as an initial treatment and as a later line of therapy." Genmab continues expanding epcoritamab's development across hematologic malignancies through multiple ongoing Phase 3 trials in collaboration with AbbVie. Autolus Therapeutics plc (NASDAQ: AUTL) presented initial clinical data from its CATULUS Phase 1 trial demonstrating obe-cel achieved a 95.5% overall response rate with 90.9% complete response in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The safety profile was consistent with the adult experience, showing low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (both 8.7%), with 20 of 21 responding patients remaining in ongoing remission at data cutoff. "Pediatric patients with r/r B-ALL have a poor prognosis, particularly those who relapse early," said Dr. Matthias Will, Chief Development Officer of Autolus. "We were pleased to share the first data from the Phase 1 CATULUS trial showing obe-cel can produce high remission rates in this pediatric patient population, including in patients with high-risk relapse and patients with primary CNS relapse. Consistent with our experience in the adult population, data show low rates of severe CRS and ICANS." Autolus also presented post-hoc analyses from the FELIX pivotal trial demonstrating that CAR T-cell persistence at three months post-infusion may serve as a marker for predicting long-term outcomes in adult r/r B-ALL patients. Planning for the Phase 2 expansion of the CATULUS trial is underway to further explore obe-cel in pediatric relapsed/refractory B-ALL patients. Lyell Immunopharma, Inc. (NASDAQ: LYEL) presented new clinical data from its ongoing trial of rondecabtagene autoleucel showing 93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with relapsed/refractory large B-cell lymphoma in the third-or-later-line setting at the 67th American Society of Hematology Annual Meeting. Patients evaluated in the second-line setting, comprised predominantly of those with primary refractory disease, achieved an 83% overall response rate and 61% complete response rate, with 70% of complete responders remaining in complete response at six months or longer. "These data from the ongoing clinical trial showing high rates of durable complete responses along with a manageable safety profile in patients with high-risk large B-cell lymphoma represent the potential of ronde-cel to improve patient outcomes," said Sarah M. Larson, MD, Associate Professor at the David Geffen School of Medicine, University of California, Los Angeles. "The two pivotal trials underway, including the first-of-its kind head-to-head CAR T-cell trial, are expected to provide a comprehensive and robust evaluation of the potential for ronde-cel to demonstrate differentiated benefit over approved CD19 CAR T-cell therapies." Ronde-cel demonstrated a manageable safety profile appropriate for outpatient administration with no high-grade cytokine release syndrome and five percent or less of patients experiencing Grade 3 or greater immune effector cell-associated neurotoxicity syndrome following dexamethasone prophylaxis. Lyell has initiated two pivotal clinical trials, PiNACLE-H2H, a Phase 3 head-to-head randomized controlled trial versus lisocabtagene maraleucel or axicabtagene ciloleucel in the second-line setting, and PiNACLE, a single-arm registration trial enrolling up to 120 patients in the third-or-later-line setting. Article Sources: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of GT Biopharma, Inc. but reserve the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of GT Biopharma, Inc. by CDMG; this is a paid advertisement, we currently own shares of GT Biopharma, Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: 1. 2. 3. Logo - 21% more press release views with Request a Demo

Clinical ResultImmunotherapyPhase 2Phase 1Phase 3

17 Dec 2025

·www.biospace.com

The 7 Most Impactful M&A Deals of 2025

iStock, RomoloTavani These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech. 2025 proved to be a high-drama year for dealmaking as pharmas fought over companies, swallowed their rivals and found inspiration in other companies’ transactions. The biggest deal of the year—Johnson & Johnson’s $14.6 billion buy of Intra-Cellular all the way back in January—didn’t even make the list of what BioSpace editors consider the most influential M&A deals of the year. While the year won’t go down as the biggest in value by any means, some of these deals will have an indelible impact on the industry for years to come. Pharmas dealt in obesity, cancer, cell therapy, mental health and a slate of others, growing and expanding their businesses. These deals, such as Pfizer’s fight to get an up-and-coming obesity biotech, AbbVie doubling down on psychedelics for mental health conditions and the fall of gene therapy’s darling shook and reshaped the biopharma sector in 2025, setting up excitement for the year ahead. Read on for 2025’s seven most impactful biopharma M&A deals. 1. The Pfizer/Novo/Metsera Saga, Obviously There could only be one story in the top spot, and it was the epic bidding war between Pfizer and Novo Nordisk over obesity startup Metsera. To make a long story short: Pfizer tried and repeatedly failed to develop a competitive obesity pipeline in-house. After several flunks earlier in 2025, the company looked to its business development team. Pfizer made a $4.9 billion offer for Metsera in September, to gain access to a long-acting GLP-1 and a long-acting amylin analogue. The deal seemed to be on the way to closing, until Novo offered an unsolicited $8.5 billion bid for the company a month later. Facing a different set of problems as the obesity space’s early leader, Novo was looking to rebuild its pipeline as rival Eli Lilly seemingly scored one win after another. A series of counteroffers, legal threats and FTC scrutiny followed, with Pfizer finally winning out for a price of about $9.2 billion for Metsera. With the dust now settled, Pfizer is back in the obesity business. The size of the obesity market, according to a Reports and Data analysis, is set to hit $27 billion yearly by as soon as 2028 and $150 billion by the early 2030s. The fight over Metsera seemed to indicate that Big Pharmas are still willing to go big in the obesity market. On the other hand, analysts wondered: Was it worth it? Obesity Is Metsera Worth the Fuss? Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort? November 5, 2025 · 4 min read · Annalee Armstrong 2. BMS Spends $1.5B for Orbital as Others Retreat From Cell Therapy Over the course of 2025, there was a massive pullback from cell therapy, with Takeda and Novo Nordisk abandoning billions in long-term investments. But Bristol Myers Squibb doubled down. The Big Pharma plunked down $1.5 billion to get Orbital Therapeutics, snagging OTX-201, a circular RNA therapy that induces a patient’s own cells to make anti-CD19 CAR type constructs. The therapy is being tested to treat B cell–driven autoimmune disorders. The Orbital deal deepens BMS’ roots in cell therapy, adding to its approved anti-BCMA therpay Abecma , for relapsed or refractory multiple myeloma, and the CD19-directed Breyanzi for blood cancers. But the buy also told the industry that there is still potential in cell therapy if you know where to look. 3. Novo Deepens MASH Stature With $5.2B Akero Buy Metabolic dysfunction–associated steatohepatitis—MASH—is suddenly one of the buzziest sectors in the pharma industry again. Novo Nordisk paid $5.2 billion to get Akero Therapeutics in October, adding efruxifermin, which reduced liver fibrosis by 24% in a Phase IIb study that read out earlier this year . It was such a good result that it pushed Roche to go hunting for an anti-MASH molecule, spurring that company’s purchase of 89bio for $3.5 billion in September. The Akero buy only deepened Novo Nordisk’s presence in the MASH space, as its multi-blockbuster GLP-1 Wegovy received approval for the liver condition in August . The Roche and Novo deals marked a turning point for the MASH space, which Big Pharma had largely abandoned years ago after numerous failures. The small biopharma Madrigal Pharmaceuticals finally broke through with the 2024 approval of Rezdiffra in MASH, reigniting interest in the space. Psychedelics Psychedelics Space Enters New Era as AbbVie Dives In With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval. September 22, 2025 · 6 min read · Heather McKenzie 4. AbbVie Goes Back to the Mental Health Well With Gilgamesh Buy AbbVie paid $1.2 billion to get just one asset from neurotech biotech Gilgamesh Pharmaceuticals in August . That gave them an entree at a table that Big Pharma has nibble at for a while: psychedelics. AbbVie gained bretisilocin, a fast-acting analogue of dimethyltryptamine (DMT) for major depressive disorder (MDD). The rest of Gilgamesh’s pipeline spun out into a separate company, Gilgamesh Pharma Inc., which carries on an existing AbbVie partnership. The Gilgamesh buy suggested that AbbVie was undeterred after a $9 billion quagmire in the form of Cerevel . AbbVie paid the princely sum to get the company and its schizophrenia asset emraclidine in 2023, which went on to flunk Phase II trials one year later . The Gilgamesh deal helped galvanize interest in psychedelics. AbbVie’s investment came at a time when most neuropsych-focused pharmas “have kept a distance,” from psychedelics according to Aaron Bartlone, CEO of the Canadian mental health biotech Cybin. The only other Big Pharmas in the psychedelics space right now are Johnson & Johnson, with its ketamine derivative Spravato, and Japanese giant Otsuka. The latter paid $59 million in 2023 to absorb Mindset, a Canadian psychedelics biotech. 5. Bluebird—Ahem, Genetix—Goes Private Bluebird was the standard bearer of gene therapy, until it wasn’t. Private equity outfits The Carlyle Group and SK Capital bought the biotech, which at one time had been worth north of $10 billion, for a scant $50 million in February . It was a precipitous fall for bluebird, which had more than $1 billion in cash the first quarter of 2021. That number fell to just $118.7 million by the third quarter of 2023 . Gene therapy is facing a “ cold winter ,” as promising science has not translated to good business, with sky-high costs and infrastructure issues hobbling the sector. Still, Carlyle and SK have options for turning bluebird’s assets into profits—including just selling the three approved gene therapies off, as PitchBook Senior Biotech Analyst Kazi Helal suggested to BioSpace in July. Those assets are Lyfgenia for sickle cell disease, Skysona for cerebral adrenoleukodystrophy and Zynteglo for beta thalassemia. Bluebird’s sale was the biggest indicator of a growing trend: the entry of private equity into the biotechnology space. In the last few years, PE firms like BlackStone have launched life sciences–focused funds, put billions of dollars into backing new ventures and even funded individual professors’ research. Bluebird renamed itself to Genetix in September , shedding a unique biopharma name adopted in 2010 and returning to its original moniker. Deals Bluebird Go-Private Deal Signals the ‘PE-ization of Pharma’ Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know. July 2, 2025 · 7 min read · Annalee Armstrong 6. Once Hot Sage Fades Away in Supernus Buy In late November 2024, Sage’s lead asset dalzanemdor flunked a Phase II trial for Huntington’s disease, the third such fail for the drug. It was just the capstone of a series of setbacks for Sage over the last few years; another asset, SAGE-324, flunked a Phase II study for essential tremor and was discontinued, and its Biogen-partnered postpartum depression drug Zurzuvae failed to get FDA approval in major depressive disorder. Maryland-based Supernus stepped in and scooped up Sage for $795 million in June . It was a “good end” for the company, according to analysts, and represented a much larger buyout than one put forward by long-time partner Biogen in January. Biogen offered $469 million to fold in its partner in Zurzuvae in January 2025 . Sage declined the offer with extreme prejudice, going so far as to sue Biogen. Along with Zurzuvae, Supernus absorbed Sage’s other approved drugs: the ADHD medication Qelbree; Onapgo, a wearable device for treating motor fluctuations associated with Parkinson’s disease; and Gocovri, for treating dyskinesia in Parkinson’s. Stifel analysts, writing at the time of the Supernus buy, said that it “feels like an unremarkable outcome for a company that was once one of the hottest stories” in treating central nervous system disorders. 7. BioNTech Ends CureVac Rivalry With a Pot of Money In 2022, BioNTech said in a lawsuit that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Three years later, BioNTech bought that company, CureVac, for $1.25 billion, ending a winding legal drama that was still ongoing at the time of the deal. That purchase gave BioNTech a new mRNA-based therapy for the tough brain cancer glioblastoma. Despite both companies gaining fame for working on vaccines, the deal was motivated mostly by interest in cancer. Getting access to CureVac’s pipeline of cancer immunotherapies “marks the next milestone in the execution of [BioNTech’s] oncology strategy,” the company said in announcing the deal. Despite regulatory headwinds prevailing against mRNA-based therapies and vaccines in the U.S.—like the federal government canceling hundreds of millions of dollars in research dollars aimed at projects using the technology—BioNTech’s bid to swallow up its rival is a signal that, even as the company diversifies into other modalities like bispecifics , mRNA-based therapies as a platform are here to stay. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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AcquisitionPhase 2Phase 3ImmunotherapyDrug Approval

15 Dec 2025

·www.drugs.com

FDA Approves Breyanzi for Relapsed, Refractory Marginal Zone Lymphoma

MONDAY, Dec. 15, 2025 -- The U.S. Food and Drug Administration has approved a new indication for Breyanzi (lisocabtagene maraleucel) for treating adults with marginal zone lymphoma (MZL) who have failed treatment or relapsed after two or more prior lines of therapy. Breyanzi is a chimeric antigen receptor T-cell therapy that genetically engineers a patient's own T-cells (collected via leukapheresis) to target and kill cancer cells. Patients receive a single dose of Breyanzi two to seven days after completing preparatory chemotherapy to deplete the recipient’s lymphocytes. For this application, the FDA granted Breyanzi priority review and orphan drug designation. The approval was based on an open-label, multicenter, single-arm trial that included 66 patients, of whom 95.5 percent experienced a response to treatment and 62.1 percent had a complete response without signs of marginal zone lymphoma on imaging scans. After a median follow-up of 21.6 months, the responses were durable. The most common adverse reactions included cytokine release syndrome, diarrhea, fatigue, musculoskeletal pain, and headache. "Today's approval reflects the FDA's continuing commitment to advance cell therapies to meet the needs of patients with rare cancers," Vijay Kumar, M.D., from the FDA Center for Biologics Evaluation and Research, said in a statement. "In granting approval, FDA took into consideration the high and durable response rate following a one-time treatment in patients with MZL, almost half of whom had either progression within two years of diagnosis or had refractory disease." Approval of Breyanzi was granted to Juno Therapeutics. More Information

$FDA Approves Breyanzi for Relapsed, Refractory Marginal Zone Lymphoma$

Cell TherapyDrug ApprovalImmunotherapyOrphan DrugClinical Result

100 Deals associated with Lisocabtagene maraleucel

External Link

KEGG	Wiki	ATC	Drug Bank
D11990	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Marginal zone lymphoma recurrent	United States	Juno Therapeutics, Inc.	04 Dec 2025
Refractory Marginal Zone Lymphoma	United States	Juno Therapeutics, Inc.	04 Dec 2025
Mantle cell lymphoma recurrent	European Union	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma recurrent	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma recurrent	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma recurrent	Norway	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma refractory	European Union	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma refractory	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma refractory	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Mantle cell lymphoma refractory	Norway	Bristol-Myers Squibb Pharma EEIG	25 Nov 2025
Recurrent Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Recurrent Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Recurrent Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Recurrent Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Refractory Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Refractory Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Refractory Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Refractory Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Mantle-Cell Lymphoma	United States	Juno Therapeutics, Inc.	31 May 2024
Chronic Lymphocytic Leukemia	United States	Juno Therapeutics, Inc.	18 Mar 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic lymphocytic leukaemia refractory	NDA/BLA	United States	Bristol Myers Squibb Co.	18 Nov 2023
Recurrent Chronic Lymphoid Leukemia	NDA/BLA	United States	Bristol Myers Squibb Co.	18 Nov 2023
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	United States	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Japan	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Belgium	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Finland	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	France	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Germany	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Italy	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Netherlands	Celgene Corp.	23 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Large B-cell lymphoma	127	Lisocabtagene maraleucel (liso-cel)	kncellhxzf(shdinvcwdc) = zhsrceguof airebtkadq (afcnqhokoh ) View more	Positive	06 Dec 2025
				Axicabtagene ciloleucel (axi-cel)	gxpidrqadr(xthstzcilh) = bobwtqavlh sxtnnayvnp (dvukwqfghn ) View more
ASH2025	Not Applicable	Large B-cell lymphoma Second line	142	Axi-cel	onddkrojto(vgowsvsylu) = qnegudmovh bbxjytwhib (vhxuncmhoi ) View more	Positive	06 Dec 2025
				Liso-cel	onddkrojto(vgowsvsylu) = riawbwfgah bbxjytwhib (vhxuncmhoi ) View more
NCT03575351 (TRANSFORM, ASH2025)	Phase 1	Large B-cell lymphoma Second line albumin \| hemoglobin \| AST ... View more	127	Liso-cel	wwctioqiuw(eguiyjngxy) = aupurnrrhh pfbrbwyptn (secdlbupkm ) View more	Positive	06 Dec 2025
				SOC	ddywnpaxnq(mlrruhnqan) = jgdmhclrsd agjewtkfyi (focchzkwqr ) View more
ASH2025	Not Applicable	Chronic Lymphocytic Leukemia	30	Lisocabtagene maraleucel (liso-cel)pirtobrutinibel (liso-cel) (received pirtobrutinib as their last line of therapy)	nkhuodzueb(ylzafhqvni) = Twenty-six patients (87%) experienced any grade cytokine release syndrome (CRS), and 3 patients experienced grade 3 CRS (10%). Twelve patients (40%) experienced any grade immune effector cell-associated neurotoxicity syndrome (ICANS), and 4 patients (13%) experienced grade 3 ICANS. There were no grade 4 or 5 CRS or ICANS. One patient experienced grade 3 immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). fzizrwkmif (ibrnhwvgmz )	Positive	06 Dec 2025
				Lisocabtagene maraleucel (liso-cel)pirtobrutinibo-cel) (did not receive pirtobrutinib as their last line of therapy)
NCT04245839 (TRANSCEND FL, ASH2025)	Phase 2	-	67	Liso-cel	qbwwqdjdhz(ptorerjmtq) = nlfpqlmuqv ksshryefyy (kjwavblkfn ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Diffuse large B-cell lymphoma recurrent Second line	805	Axi-cel	ctrusbchdj(jvuufazudh) = icvvnmkjph dcpzucfbsd (xkyedrnknl ) View more	Similar	06 Dec 2025
				Liso-cel	ctrusbchdj(jvuufazudh) = gkaylcdsnt dcpzucfbsd (xkyedrnknl ) View more
NCT04245839 (TRANSCEND FL, ASH2025)	Phase 1	Follicular Lymphoma Third line	107	Lisocabtagene Maraleucel (liso-cel) (Progression within 24 months from first-line chemoimmunotherapy (POD24) yes)	uytxebznlv(wxicgsjmla) = eachjlzneo nwdnisjaod (yrecuqahuk ) View more	Positive	06 Dec 2025
				Lisocabtagene Maraleucel (liso-cel) (Progression within 24 months from first-line chemoimmunotherapy (POD24) no)	uytxebznlv(wxicgsjmla) = eqqfdxigvq nwdnisjaod (yrecuqahuk ) View more
ASH2025	Not Applicable	Large B-cell lymphoma	116	CD19-directed CAR T	ratnlbyaou(ohcjugmovu) = CD19 antigen density was significantly reduced at progression (2541 m/c, IQR 486-5340), relative to pre-treatment (5493 m/c, IQR 2011-8825)(p=2.8x10-4). mxwdajjxxa (rkhfotktsz ) View more	Positive	06 Dec 2025
NCT03483103 (PILOT, Pubmed) Manual	Phase 2	Large B-cell lymphoma Second line	61	Lisocabtagene maraleucel	xzfiktupxb(euuidfyzpw) = ezczxknldo zracpvslea (ztkmjavfdu ) View more	Positive	12 Aug 2025
NCT03575351 (TRANSFORM \| TRANSFORM study, CTgov)	Phase 3	Refractory Aggressive Non-Hodgkin Lymphoma \| Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma	184	R-DHAP+JCAR017 (Standard of Care Arm)	ydaveaidjc(iiuwigcvyv) = zpfpexvsod njgfikyohr (ckdylcmtls, jnnjadwezk - keeoaoeomf) View more	-	03 Aug 2025
				JCAR017-positive viable transduced T cells (CAR+ T cells)+Fludarabine+cyclophosphamide+JCAR017 (Liso-cel Arm)	ydaveaidjc(iiuwigcvyv) = uuzotckhgu njgfikyohr (ckdylcmtls, lhzfvorrud - zqvkkeengz) View more

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