Acute Myeloid Leukemia Clinical Trial Pipeline Analysis: 25+ Key Companies Shaping the Future of AML Therapeutics | DelveInsight

DelveInsight's Acute Myeloid Leukemia (AML) Pipeline Insight 2026 report provides comprehensive global coverage of available, marketed, and pipeline Acute Myeloid Leukemia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the AML pipeline domain.

Key takeaways from the Acute Myeloid Leukemia Clinical Trial Landscape Report
• DelveInsight's Acute Myeloid Leukemia pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for AML treatment.
• Key AML companies such as Orca Bio, Stemline Therapeutics, Akeso Biopharma, Aptevo Therapeutics, Mendus AB, Senti Biosciences, AB Science, HUTCHMED, and others
• Promising AML pipeline therapies in various stages of development include Orca-T, Tagraxofusp, AK117, APVO436, Vididencel, SENTI-202, and others

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What is Acute Myeloid Leukemia (AML)?
Acute Myeloid Leukemia (AML) is the most common leukemia among the adult population and accounts for about 80% of all cases. It is characterized by clonal expansion of immature blast cells in the peripheral blood and bone marrow resulting in ineffective erythropoiesis and bone marrow failure. Symptoms commonly include fatigue, weakness, fever, night sweats, weight loss, anemia, infections, easy bruising, bleeding gums, and enlarged liver or spleen. AML is classified based on genetic abnormalities, cell differentiation, and disease origin. Diagnosis involves blood tests, bone marrow aspiration and biopsy, along with genetic and molecular analyses. Treatment mainly includes chemotherapy, targeted therapies, stem cell transplantation, and supportive care.

Emerging AML Drug Profiles

Orca-T: Orca Bio
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells, and conventional T-cells derived from matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation from the US FDA. The US FDA has also accepted the Biologics License Application for Orca-T under Priority Review with a Prescription Drug User Fee Act target action date of April 6, 2026.

Tagraxofusp: Stemline Therapeutics
Tagraxofusp is a recombinant fusion protein being evaluated for the treatment of Acute Myeloid Leukemia. The therapy targets CD123 and is currently in Phase II clinical development. The drug is being investigated for its role in improving treatment outcomes in patients with AML and related hematologic malignancies.

Learn more about the novel and emerging AML pipeline therapies https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-pipeline-insight?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

Recent Developments in the AML Clinical Trial Landscape
• In January 2026, Ipsen announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine in first-line unfit acute myeloid leukemia.
• In November 2025, the FDA granted Orphan Drug Designation to the investigational myeloid-targeted immunotherapy M2T-CD33 (LTI-214) as a potential therapeutic option for patients with acute myeloid leukemia.
• In January 2026, Orca Bio announced the completion of a Series F financing round led by Lightspeed Venture Partners to support commercial readiness for Orca-T and advance its clinical pipeline.
• In October 2025, Orca Bio announced that the FDA had accepted for Priority Review the Biologics License Application seeking approval for Orca-T for the treatment of hematological malignancies including AML.

Scope of the AML Pipeline Report
• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase I/II, Phase II, Phase III, Registered
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Unspecified
• Therapeutics Assessment By Molecule Type: Cell therapy, Recombinant fusion protein, Monoclonal antibody, Bispecific antibody
• Key AML Companies: Orca Bio, Stemline Therapeutics, Akeso Biopharma, Aptevo Therapeutics, Mendus AB, Senti Biosciences, AB Science, and others
• Key AML Pipeline Therapies: Orca-T, Tagraxofusp, AK117, APVO436, Vididencel, SENTI-202, and others

Dive deep into rich insights for new drugs for AML treatment, visit https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-pipeline-insight?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

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

For further information on the AML pipeline therapeutics, reach out https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-pipeline-insight?utmsource=openpr&utm_medium=pressrelease&utm_campaign=kspr

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