Acute Myeloid Leukemia Pipeline 2025: Groundbreaking Clinical Advancements by 110+ Global Leaders - DelveInsight | Featuring Sellas Life Sciences Group, Stemline Therapeutics, Inc., Wugen, Inc., Schrodinger, Inc., MEI Pharma, Inc., Vor Bio, TC BioPharm, P

With Acute Myeloid Leukemia reaching epidemic proportions globally and contributing significantly to comorbid conditions such as diabetes, cardiovascular disease, and certain cancers, there is a growing demand for safer, more effective treatment options. According to DelveInsight, the Acute Myeloid Leukemia pipeline comprises 110+ pharmaceutical and biotech companies actively developing 120+ therapeutic candidates targeting Acute Myeloid Leukemia. These therapies span various stages of clinical and non-clinical development, underscoring the intense innovation and commitment to addressing one of the most pressing public health challenges of our time.
DelveInsight's "Acute Myeloid Leukemia Pipeline Insight 2025" report provides a detailed and strategic evaluation of the ongoing R&D landscape. It covers clinical trial progression, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report serves as a crucial resource for stakeholders, including researchers, healthcare investors, and decision-makers, seeking insights into the evolving Acute Myeloid Leukemia Therapeutics Market and the breakthroughs shaping its future trajectory.

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Key Takeaways from the Acute Myeloid Leukemia Pipeline Report

DelveInsight's Acute Myeloid Leukemia pipeline report depicts a robust space with 110+ active players working to develop 120+ pipeline therapies for Acute Myeloid Leukemia treatment.
In March 2025, CERo Therapeutics Holdings, Inc. received a favorable FDA review for its IND amendment related to Chemistry, Manufacturing, and Controls (CMC), paving the way for patient dosing and trimming approximately one week off the production timeline.
In February 2025, Moleculin Biotech, Inc. gained FDA input on its IND amendment, enabling a reduction in the trial size for its Phase 3 AnnAraC study-testing Annamycin + Cytarabine in patients with relapsed or refractory AML (R/R AML).
In February 2025, Kura Oncology and Kyowa Kirin reported positive topline results from KOMET-001, a Phase 2 registration-focused trial of ziftomenib, an oral menin inhibitor for relapsed/refractory AML patients with NPM1 mutations.
In February 2025, Auron Therapeutics revealed advancement in its KAT2A/B program, including progress on the clinical candidate AUTX-703, alongside completing a $27 million Series B financing round to support further development.
In January 2025, Medexus announced FDA approval of GRAFAPEXTM, an alkylating agent combined with fludarabine, for use as a preparative regimen in alloHSCT for AML and MDS patients aged one year and older.
In January 2025, PureTech Health received Fast Track designation from the FDA for LYT-200, an investigational AML therapy, aimed at expediting development and review due to the urgent need for new treatment options.
Key Acute Myeloid Leukemia companies such as Sellas Life Sciences Group, Stemline Therapeutics, Inc., Wugen, Inc., Schrodinger, Inc., MEI Pharma, Inc., Vor Bio, TC BioPharm, Pacylex Pharmaceuticals, Vor Biopharma, Vincerx Pharma, Inc., Aptose Biosciences Inc., Tr1X, Inc., TC Biopharm, Zhejiang ACEA Pharmaceutical Co. Ltd., BeiGene, Sellas Life Sciences Group, Seagen Inc., Sanofi, Servier Bio-Innovation LLC, Ryvu Therapeutics SA, Remix Therapeutics, Prelude Therapeutics, Precigen, Inc, PharmaEngine, Orca Biosystems, Inc., Immune System Key Ltd, MacroGenics, Sutro Biopharma, Inc., and others are evaluating new drugs for Acute Myeloid Leukemia to improve the treatment landscape.
Promising Acute Myeloid Leukemia pipeline therapies in various stages of development include Galinpepimut-S, Tagraxofusp, WU-NK-101, SGR-2921, Voruciclib, VADC45, and others.

Acute Myeloid Leukemia Overview:

Acute Myeloid Leukemia (AML) is an aggressive blood cancer characterized by the abnormal expansion of immature myeloid cells (blasts) in the bone marrow and bloodstream. This proliferation disrupts normal blood cell formation-leading to impaired production of red blood cells and platelets through faulty erythropoiesis and megakaryopoiesis. This results in rapid bone marrow failure, setting AML apart from slower-progressing forms of leukemia.

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Acute Myeloid Leukemia Pipeline Analysis
The Acute Myeloid Leukemia pipeline insights report 2025, provides insights into:
Provides comprehensive insights into key companies developing therapies in the Acute Myeloid Leukemia Market.

Categorizes Acute Myeloid Leukemia therapeutic companies by development stage: early, mid, and late-stage.

Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

Reviews emerging Acute Myeloid Leukemia drugs under development based on:

Stage of development

Acute Myeloid Leukemia Route of administration

Target receptor

Monotherapy vs. combination therapy

Acute Myeloid Leukemia Mechanism of action

Molecular type

Offers detailed analysis of:

Company-to-company and company-academia collaborations

Acute Myeloid Leukemia Licensing agreements

Funding and investment activities supporting future Acute Myeloid Leukemia market advancement.

Unlock key insights into emerging Acute Myeloid Leukemia therapies and market strategies here: https://www.delveinsight.com/report-store/acute-myeloid-leukemia-aml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Acute Myeloid Leukemia Emerging Drugs

Galinpepimut-S: Sellas Life Sciences Group

Galinpepimut-S (GPS) is an innovative immunotherapy designed to target the WT1 protein, a nuclear protein involved in the development and progression of various cancers. Although WT1 plays a critical role in fetal kidney formation, its expression diminishes in normal adult tissues, making it a prime target for cancer treatment.

GPS is being developed both as a standalone therapy and in combination with other agents to combat multiple cancer types. It consists of a mixture of four synthetic peptides, two of which have single amino acid mutations that make them appear "non-self" to the immune system. This approach reduces the likelihood of immune tolerance and boosts the immune system's ability to recognize and destroy cancer cells.

Tagraxofusp: Stemline Therapeutics, Inc.

TAGRAXOFUSP is an advanced targeted cancer therapy designed to act on the interleukin-3 receptor alpha (CD123), which is widely expressed in various malignancies. The therapy consists of recombinant human IL-3 fused to a modified diphtheria toxin (DT), where the natural receptor-binding domain of DT is replaced by IL-3. This engineered configuration enables TAGRAXOFUSP to selectively bind to and enter cells that express CD123.

Acute Myeloid Leukemia Pipeline Therapeutic Assessment

Acute Myeloid Leukemia Assessment by Product Type
• Mono
• Combination
• Mono/Combination

Acute Myeloid Leukemia 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

Acute Myeloid Leukemia Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Acute Myeloid Leukemia Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Table of Contents

1. Report Introduction
2. Executive Summary
3. Acute Myeloid Leukemia Current Treatment Patterns
4. Acute Myeloid Leukemia - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Acute Myeloid Leukemia Late-Stage Products (Phase-III)
7. Acute Myeloid Leukemia Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Acute Myeloid Leukemia Discontinued Products
13. Acute Myeloid Leukemia Product Profiles
14. Acute Myeloid Leukemia Key Companies
15. Acute Myeloid Leukemia Key Products
16. Dormant and Discontinued Products
17. Acute Myeloid Leukemia Unmet Needs
18. Acute Myeloid Leukemia Future Perspectives
19. Acute Myeloid Leukemia Analyst Review
20. Appendix
21. Report Methodology

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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.

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