Marginal Zone Lymphoma Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Beigene, InnoCare Pharma, Hutchmed, Incyte, Innovent, MorphoSys

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Marginal Zone Lymphoma pipeline constitutes 50+ key companies continuously working towards developing 50+ Marginal Zone Lymphoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Marginal Zone Lymphoma Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/marginal-zone-lymphoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Marginal Zone Lymphoma Market.

The Marginal Zone Lymphoma Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Marginal Zone Lymphoma Pipeline Report:

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Companies across the globe are diligently working toward developing novel Marginal Zone Lymphoma treatment therapies with a considerable amount of success over the years.

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Marginal Zone Lymphoma companies working in the treatment market are Carna Biosciences, Hutchmed, Incyte, Innovent, MorphoSys, Beigene, InnoCare Pharma, Beijing Mabworks Biotech Co., MEI Pharma, Inc., Kyowa Kirin, ADC Therapeutics, Loxo Oncology, Adicet Bio, Celldex Therapeutics Inc, and others, are developing therapies for the Marginal Zone Lymphoma treatment

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Emerging Marginal Zone Lymphoma therapies in the different phases of clinical trials are- AS-1763, Amdizalisib (HMPL689), Parsaclisib (IBI376), Tafasitamab, Zanubrutinib, Orelabrutinib, Tafasitamab, MIL62, Zandelisib, Loncastuximab, LOXO-305, ADI-001, CDX-1140, and others are expected to have a significant impact on the Marginal Zone Lymphoma market in the coming years.

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In August 2025, The decision specifically targets adults with relapsed or refractory MZL who have undergone at least two prior systemic therapies. Breyanzi will now undergo an expedited review, potentially accelerating patient access, with a target decision date of December 5 this year. BMS' application is supported by data from the primary analysis of the MZL cohort in the Phase 2 TRANSCEND FL study, which showed clinically significant benefits for patients treated with Breyanzi.

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In August 2025, The FDA has granted priority review to a supplemental biologics license application (sBLA) for lisocabtagene maraleucel (liso-cel; Breyanzi), seeking approval for treating adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic therapies. The application is supported by results from the MZL cohort of the Phase 2 TRANSCEND FL trial (NCT04245839). Data presented at the 2025 International Conference on Malignant Lymphoma showed that among 66 efficacy-evaluable patients, the overall response rate (ORR) was 95.5% (95% CI, 87.3%-99.1%; 1-sided P < .0001), including a complete response (CR) rate of 62.1% (95% CI, 49.3%-73.8%; 1-sided P < .0001).

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In June 2025, ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader in antibody-drug conjugates (ADCs), announced that updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of ZYNLONTA Registered for relapsed/refractory marginal zone lymphoma (r/r MZL) will be presented in a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on Friday, June 20. The data will be available online starting Wednesday, June 18, at 8:30 a.m. CEST. The single-arm, open-label study is led by Izidore S. Lossos, MD, Chief of the Division of Hematology Lymphoma Section at Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine.

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In June 2025, A rituximab and ibrutinib combination therapy demonstrates potential in treating marginal zone lymphoma (MZL), according to a poster presentation at ICML 2025. Currently, no standard first-line therapies exist for MZL patients. Previous studies have shown that BTK inhibitors offer a favorable risk-benefit profile in relapsed MZL, regardless of subtype, including splenic (SMZL) and nodal (NMZL) marginal zone lymphoma. The phase II IELSG47/MALIBU trial evaluated the efficacy and safety of combining rituximab with ibrutinib, both BTK inhibitors, for the treatment of MZL, highlighting encouraging clinical outcomes.

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In February 2025, Lisocabtagene maraleucel (Liso-cel; Breyanzi) demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in adult patients with relapsed or refractory marginal zone lymphoma (MZL), achieving the primary endpoint for the MZL cohort in the Phase 2 TRANSCEND FL trial (NCT04245839).

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In February 2025, Bristol Myers Squibb (BMS) announced that its multi-center Phase II TRANSCEND FL trial has achieved the primary endpoint in the marginal zone lymphoma (MZL) cohort. The study evaluates Breyanzi, a CD19-targeted CAR T cell therapy, in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL).

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In January 2025, Verismo Therapeutics, a clinical-stage CAR T company specializing in KIR-CAR platform technology, announced the dosing of the first patient in its CELESTIAL-301 Phase 1 clinical trial. The infusion took place at the Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado. The CELESTIAL-301 trial is designed to evaluate the safety, tolerability, and preliminary efficacy of SynKIR Trademark -310 in patients with relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). This Phase 1 multicenter trial is enrolling patients who have previously undergone CAR T therapy but relapsed or became refractory, as well as those who have never received CAR T therapy.

Marginal Zone Lymphoma Overview

Marginal Zone Lymphoma is a slow-growing type of non-Hodgkin lymphoma that originates from B-cells in the marginal zone of lymphoid tissues. It commonly affects the spleen, lymph nodes, or mucosa-associated lymphoid tissue (MALT). MZL often presents with painless swelling and may be linked to chronic infections or autoimmune disorders. Treatment varies based on the subtype and disease stage, ranging from watchful waiting to chemotherapy or targeted therapies.

Get a Free Sample PDF Report to know more about Marginal Zone Lymphoma Pipeline Therapeutic Assessment-

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Emerging Marginal Zone Lymphoma Drugs Under Different Phases of Clinical Development Include:

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AS-1763: Carna Biosciences

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Amdizalisib (HMPL689): Hutchmed

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Parsaclisib (IBI376): Incyte/Innovent

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Tafasitamab: MorphoSys/Incyte

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Zanubrutinib: Beigene

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Orelabrutinib: InnoCare Pharma

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Tafasitamab: Incyte Corporation

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MIL62: Beijing Mabworks Biotech Co.

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Zandelisib: MEI Pharma, Inc./Kyowa Kirin

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Loncastuximab: ADC Therapeutics

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LOXO-305: Loxo Oncology

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ADI-001: Adicet Bio

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CDX-1140: Celldex Therapeutics Inc

Marginal Zone Lymphoma Route of Administration

Marginal Zone Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

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Inhalation

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Inhalation/Intravenous/Oral

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Intranasal

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Intravenous

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Intravenous/ Subcutaneous

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NA

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Oral

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Oral/intranasal/subcutaneous

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Parenteral

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Subcutaneous

Marginal Zone Lymphoma Molecule Type

Marginal Zone Lymphoma Products have been categorized under various Molecule types, such as

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Antibody

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Antisense oligonucleotides

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Immunotherapy

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Monoclonal antibody

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Peptides

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Protein

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Recombinant protein

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Small molecule

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Stem Cell

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Vaccine

Marginal Zone Lymphoma Pipeline Therapeutics Assessment

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Marginal Zone Lymphoma Assessment by Product Type

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Marginal Zone Lymphoma By Stage and Product Type

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Marginal Zone Lymphoma Assessment by Route of Administration

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Marginal Zone Lymphoma By Stage and Route of Administration

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Marginal Zone Lymphoma Assessment by Molecule Type

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Marginal Zone Lymphoma by Stage and Molecule Type

DelveInsight's Marginal Zone Lymphoma Report covers around 50+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Marginal Zone Lymphoma product details are provided in the report. Download the Marginal Zone Lymphoma pipeline report to learn more about the emerging Marginal Zone Lymphoma therapies [https://www.delveinsight.com/sample-request/marginal-zone-lymphoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Marginal Zone Lymphoma Therapeutics Market include:

Key companies developing therapies for Marginal Zone Lymphoma are - Incyte Corporation, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Incyte Corporation, Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc, Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, and others.

Marginal Zone Lymphoma Pipeline Analysis:

The Marginal Zone Lymphoma pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Marginal Zone Lymphoma with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Marginal Zone Lymphoma Treatment.

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Marginal Zone Lymphoma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Marginal Zone Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Marginal Zone Lymphoma market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Marginal Zone Lymphoma drugs and therapies [https://www.delveinsight.com/sample-request/marginal-zone-lymphoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Marginal Zone Lymphoma Pipeline Market Drivers

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Increasing Prevalence, increased research and development are some of the important factors that are fueling the Marginal Zone Lymphoma Market.

Marginal Zone Lymphoma Pipeline Market Barriers

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However, therapies with moderately good patient outcomes, long treatment course and other factors are creating obstacles in the Marginal Zone Lymphoma Market growth.

Scope of Marginal Zone Lymphoma Pipeline Drug Insight

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Coverage: Global

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Key Marginal Zone Lymphoma Companies: Carna Biosciences, Hutchmed, Incyte, Innovent, MorphoSys, Beigene, InnoCare Pharma, Beijing Mabworks Biotech Co., MEI Pharma, Inc., Kyowa Kirin, ADC Therapeutics, Loxo Oncology, Adicet Bio, Celldex Therapeutics Inc, and others

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Key Marginal Zone Lymphoma Therapies: AS-1763, Amdizalisib (HMPL689), Parsaclisib (IBI376), Tafasitamab, Zanubrutinib, Orelabrutinib, Tafasitamab, MIL62, Zandelisib, Loncastuximab, LOXO-305, ADI-001, CDX-1140, and others

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Marginal Zone Lymphoma Therapeutic Assessment: Marginal Zone Lymphoma current marketed and Marginal Zone Lymphoma emerging therapies

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Marginal Zone Lymphoma Market Dynamics: Marginal Zone Lymphoma market drivers and Marginal Zone Lymphoma market barriers

Request for Sample PDF Report for Marginal Zone Lymphoma Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/marginal-zone-lymphoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Marginal Zone Lymphoma Report Introduction

2. Marginal Zone Lymphoma Executive Summary

3. Marginal Zone Lymphoma Overview

4. Marginal Zone Lymphoma- Analytical Perspective In-depth Commercial Assessment

5. Marginal Zone Lymphoma Pipeline Therapeutics

6. Marginal Zone Lymphoma Late Stage Products (Phase II/III)

7. Marginal Zone Lymphoma Mid Stage Products (Phase II)

8. Marginal Zone Lymphoma Early Stage Products (Phase I)

9. Marginal Zone Lymphoma Preclinical Stage Products

10. Marginal Zone Lymphoma Therapeutics Assessment

11. Marginal Zone Lymphoma Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Marginal Zone Lymphoma Key Companies

14. Marginal Zone Lymphoma Key Products

15. Marginal Zone Lymphoma Unmet Needs

16 . Marginal Zone Lymphoma Market Drivers and Barriers

17. Marginal Zone Lymphoma Future Perspectives and Conclusion

18. Marginal Zone Lymphoma Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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