Waldenstrom's Macroglobulinemia Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

(Albany, USA) DelveInsight's "Waldenstrom's Macroglobulinemia Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Waldenstrom's macroglobulinemia market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

The Waldenström's macroglobulinemia landscape is experiencing significant advancements, powered by cutting-edge research and transformative therapies. Leading biopharmaceutical companies like BeiGene, Janssen, Ascentage Pharma, Gilead Sciences, ADC Therapeutics, InnoCare Pharma, and Mustang Bio are spearheading the development of novel treatments, offering hope for more effective and personalized therapies for WM patients. Through their innovative approaches, these pioneers are reshaping the therapeutic landscape, bringing forward targeted therapies and novel immunotherapies that aim to improve survival rates and quality of life for individuals battling this rare and complex blood cancer.

For emerging Waldenstrom's macroglobulinemia drugs, the Waldenstrom's macroglobulinemia pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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Key Takeaways from the Waldenstrom's Macroglobulinemia Pipeline Report
• DelveInsight's Waldenstrom's macroglobulinemia Pipeline analysis depicts a robust space with 20+ active players working to develop 22+ pipeline drugs for Waldenstrom's macroglobulinemia treatment.
• The leading Waldenstrom's macroglobulinemia companies include Amgen, Abbvie, Roche, Bristol-Myers Squibb, X4 Pharmaceuticals, TransThera Sciences, BeiGene, Janssen, Ascentage Pharma, Gilead Sciences, ADC Therapeutics, InnoCare Pharma, Mustang Bio, and others are evaluating their lead assets to improve the Waldenstrom's macroglobulinemia treatment landscape.
• Key Waldenstrom's macroglobulinemia pipeline therapies in various stages of development include Carfilzomib, ABT199, Obinutuzumab, Dasatinib, Mavorixafor, TT-01488, BGB 16673, Zydelig, Daratumumab, APG-2575, loncastuximab tesirine, Orelabrutinib, MB-106, and others.
• In March 2025, Nurix Therapeutics, Inc. (Nasdaq: NRIX) announced that the FDA granted Orphan Drug Designation to bexobrutideg (NX-5948), a selective BTK degrader, for the treatment of Waldenström macroglobulinemia (WM).
• In December 2024, Nurix Therapeutics, Inc. announced that the FDA granted Fast Track designation for NX-5948, for treating adult patients with relapsed or refractory Waldenstrom's macroglobulinemia (WM) after at least two prior therapies, including a BTK inhibitor.
• In June 2024, Mustang Bio, Inc. (Nasdaq: MBIO) announced updated data from its ongoing Phase 1/2 trial of MB-106, a CD20-targeted autologous CAR T-cell therapy, showing favorable safety and efficacy in patients with Waldenström macroglobulinemia (WM), a rare blood cancer.

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Waldenstrom's Macroglobulinemia Overview
Waldenström macroglobulinemia (WM) is a rare, slow-growing non-Hodgkin lymphoma where abnormal B cells proliferate in the bone marrow, producing excess immunoglobulin M (IgM). It mainly affects adults over 65 and is characterized by symptoms like fatigue, weakness, weight loss, anemia, neuropathy, bleeding, and hyperviscosity syndrome (thickened blood from high IgM levels), causing headaches, vision issues, and dizziness. Diagnosis typically involves blood tests showing elevated IgM, a bone marrow biopsy to identify lymphoplasmacytic cells, imaging (CT/MRI) to assess disease spread, and genetic testing for the MYD88 L265P mutation.

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Waldenstrom's Macroglobulinemia Treatment Analysis: Drug Profile
Lisaftoclax: Ascentage Pharma
Lisaftoclax is a highly selective Bcl-2 inhibitor that induces apoptosis and inhibits cell growth. In a global Phase Ib/II study, lisaftoclax monotherapy demonstrated promising antitumor activity and a favorable safety profile in patients with relapsed/refractory (R/R) Waldenström macroglobulinemia (WM) who had previously been treated with BTK inhibitors. Additionally, a 100% response rate was observed when lisaftoclax was combined with a BTK inhibitor for treatment-naïve WM patients. The drug is currently in Phase II development for WM.

ABT-199 (Venetoclax): AbbVie
ABT-199 (venetoclax) is a Bcl-2 inhibitor designed to target Bcl-2, an apoptosis regulator that is highly expressed in leukemia cells, contributing to their prolonged survival. Venetoclax blocks Bcl-2 activity, promoting cell death in malignant cells. Clinical trials evaluating ABT-199 for Waldenström's macroglobulinemia are currently in Phase II, conducted in collaboration with Dana-Farber Cancer Institute.

Key Waldenstrom's Macroglobulinemia Therapies and Companies
• Sonrotoclax: BeiGene
• ACP-196: Acerta Pharma BV
• Lopofosine I 131: Cellectar Biosciences
• Lisaftoclax: Ascentage Pharma
• ABT-199 (Venetoclax): AbbVie
• TT-01488: TransThera Biosciences

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Waldenstrom's Macroglobulinemia Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Waldenstrom's Macroglobulinemia Pipeline Report
• Coverage: Global
• Key Waldenstrom's Macroglobulinemia Companies: Amgen, Abbvie, Roche, Bristol-Myers Squibb, X4 Pharmaceuticals, TransThera Sciences, BeiGene, Janssen, Ascentage Pharma, Gilead Sciences, ADC Therapeutics, InnoCare Pharma, Mustang Bio, and others.
• Key Waldenstrom's Macroglobulinemia Pipeline Therapies: Carfilzomib, ABT199, Obinutuzumab, Dasatinib, Mavorixafor, TT-01488, BGB 16673, Zydelig, Daratumumab, APG-2575, loncastuximab tesirine, Orelabrutinib, MB-106, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Waldenstrom's Macroglobulinemia Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Waldenstrom's Macroglobulinemia Pipeline Therapeutics
6. Waldenstrom's Macroglobulinemia Pipeline: Late-Stage Products (Phase III)
7. Waldenstrom's Macroglobulinemia Pipeline: Late-Stage Products (Phase III)
8. Waldenstrom's Macroglobulinemia Pipeline: Mid-Stage Products (Phase II)
9. Waldenstrom's Macroglobulinemia Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
https://www.delveinsight.com/ats-conference-coverage

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.