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“Relapsed/Refractory Acute Myeloid Leukemia Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Relapsed/Refractory Acute Myeloid Leukemia Market.

The Relapsed/Refractory Acute Myeloid Leukemia 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 Relapsed/Refractory Acute Myeloid Leukemia Pipeline Report:

• Companies across the globe are diligently working toward developing novel Relapsed/Refractory Acute Myeloid Leukemia treatment therapies with a considerable amount of success over the years.

• Relapsed/Refractory Acute Myeloid Leukemia companies working in the treatment market are Cellectis, Foghorn Therapeutics, AB Science, Oncoceutics, Sanofi, TC Biopharm, Merck & Co, GlycoMimetics, AROG Pharmaceuticals, and others, are developing therapies for the Relapsed/Refractory Acute Myeloid Leukemia treatment

• Emerging Relapsed/Refractory Acute Myeloid Leukemia therapies in the different phases of clinical trials are- UCART 123, FHD-286, AB8939, ONC201, Sarclisa, TCB008, Keytruda, Uproleselan, Crenolanib, and others are expected to have a significant impact on the Relapsed/Refractory Acute Myeloid Leukemia market in the coming years.

• In November 2025, Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) announced that the U.S. FDA has granted full approval for KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) harboring a susceptible NPM1 mutation and lacking satisfactory alternative treatment options. KOMZIFTI is now the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a severe blood cancer with very limited therapeutic choices.

• In August 2025, Schrödinger announced the discontinuation of SGR-2921’s clinical development, a CDC7 inhibitor being tested for relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). The decision stems from safety concerns identified in an ongoing Phase 1 dose-escalation trial (NCT05961839), where investigators linked the treatment to two patient deaths in the AML cohort due to treatment-emergent adverse effects (AEs). While early signs of monotherapy activity were observed, the company concluded that advancing the program—especially in combination therapies—would be challenging given the emerging safety risks.

• In June 2025, The FDA has accepted for priority review the supplemental new drug application (sNDA) for revumenib (Revuforj), an oral, first-in-class Menin inhibitor, to treat relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). This decision reflects the critical need for innovative therapies in this aggressive leukemia subtype, known for high relapse rates and poor outcomes. The application is being evaluated under the Real-Time Oncology Review program, which accelerates access to promising cancer treatments. The Prescription Drug User Fee Act (PDUFA) target action date has been scheduled for October 25, 2025.

• In March 2025, Pacylex Pharmaceuticals announced that the first patient has been dosed in a Phase 1/2 dose-finding trial (NCT06613217) of oral zelenirstat (PCLX-001), a first-in-class N-myristoyltransferase inhibitor, for relapsed/refractory acute myeloid leukemia (AML). The study, conducted at The University of Texas MD Anderson Cancer Center, builds on a prior Phase 1 trial in solid tumors and non-Hodgkin lymphoma, along with preclinical evidence demonstrating anti-AML activity of zelenirstat.

• In December 2024, Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company specializing in oncology treatments for difficult-to-treat cancers, has released results from its Phase 3 bridging study of uproleselan in China. The trial, which involved patients with relapsed or refractory acute myeloid leukemia, did not demonstrate a positive benefit for the drug.

• In May 2024, GlycoMimetics, a biotechnology firm headquartered in the United States, has announced the key findings from its Phase III clinical trial of uproleselan, an inhibitor of E-selectin aimed at treating relapsed/refractory acute myeloid leukemia (r/r AML). The study, which was randomized, double-blind, and placebo-controlled, evaluated uproleselan in combination with either the mitoxantrone, etoposide, and cytarabine (MEC) regimen or the fludarabine, cytarabine, and idarubicin (FAI) regimen.

• In January 2024, SELLAS Life Sciences Group, Inc. has announced that the FDA has granted fast track designation to SLS009 (formerly GFH009) for potential use as a therapy in patients with relapsed or refractory acute myeloid leukemia (AML). The ongoing phase 1/2 study (NCT04588922) is evaluating the safety and effectiveness of this CDK9 inhibitor in combination with venetoclax (Venclexta) and azacitidine (Vidaza) in this patient population.

• In February 2024, Ryvu Therapeutics has administered the initial dose to the first participant in the Phase II RIVER-81 clinical trial assessing RVU120 in combination with venetoclax for adults dealing with relapsed/refractory acute myeloid leukemia (r/r AML). This multicenter, open-label trial aims to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), tolerability, and effectiveness of this drug combination.

Relapsed/Refractory Acute Myeloid Leukemia Overview

Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) is a form of acute myeloid leukemia (AML) in which the disease either returns after initial treatment (relapsed) or fails to respond to standard therapy (refractory). AML is a fast-growing cancer of the bone marrow and blood that affects myeloid cells, leading to abnormal white blood cell production. R/R AML is challenging to treat and is associated with poor prognosis, often requiring intensive chemotherapy, targeted therapies, or hematopoietic stem cell transplantation to achieve remission or control disease progression.

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Emerging Relapsed/Refractory Acute Myeloid Leukemia Drugs Under Different Phases of Clinical Development Include:

• UCART 123: Cellectis

• FHD-286: Foghorn Therapeutics

• AB8939: AB Science

• ONC201: Oncoceutics

• Sarclisa: Sanofi

• TCB008: TC Biopharm

• Keytruda: Merck & Co

• Uproleselan: GlycoMimetics

• Crenolanib: AROG Pharmaceuticals

Relapsed/Refractory Acute Myeloid Leukemia Route of Administration

Relapsed/Refractory Acute Myeloid Leukemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Intra-articular

• Intraocular

• Intrathecal

• Intravenous

• Ophthalmic

• Oral

• Parenteral

• Subcutaneous

• Topical

• Transdermal

Relapsed/Refractory Acute Myeloid Leukemia Molecule Type

Relapsed/Refractory Acute Myeloid Leukemia Products have been categorized under various Molecule types, such as

• Oligonucleotide

• Peptide

• Small molecule

Relapsed/Refractory Acute Myeloid Leukemia Pipeline Therapeutics Assessment

• Relapsed/Refractory Acute Myeloid Leukemia Assessment by Product Type

• Relapsed/Refractory Acute Myeloid Leukemia By Stage and Product Type

• Relapsed/Refractory Acute Myeloid Leukemia Assessment by Route of Administration

• Relapsed/Refractory Acute Myeloid Leukemia By Stage and Route of Administration

• Relapsed/Refractory Acute Myeloid Leukemia Assessment by Molecule Type

• Relapsed/Refractory Acute Myeloid Leukemia by Stage and Molecule Type

DelveInsight’s Relapsed/Refractory Acute Myeloid Leukemia Report covers around 75+ Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Relapsed/Refractory Acute Myeloid Leukemia product details are provided in the report. Download the Relapsed/Refractory Acute Myeloid Leukemia pipeline report to learn more about the emerging Relapsed/Refractory Acute Myeloid Leukemia therapies

Some of the key companies in the Relapsed/Refractory Acute Myeloid Leukemia Therapeutics Market include:

Key companies developing therapies for Relapsed/Refractory Acute Myeloid Leukemia are – Maxinovel Pty., Ltd., Cellectis S.A., Amgen, Ascentage Pharma, Shijiazhuang Yiling Pharmaceutical, CicloMed LLC, AB Science, Betta Pharmaceuticals Co., Ltd., Chongqing Precision Biotech Co., Ltd, Astellas Pharma, Keystone Nano, Cullinan Oncology, LLC, Arog Pharmaceuticals, Inc., GlycoMimetics Incorporated, Kite Pharma, Celyad Oncology SA, Novartis, PersonGen Biotherapeutics, Merck Sharp & Dohme LLC, Astex Pharmaceuticals, Mabwell (Shanghai) Bioscience Co., Ltd., Syndax Pharmaceuticals, Meryx, Inc., Cleave Therapeutics, Aptose Biosciences Inc., New Epsilon Innovation Limited, Guangdong Ruishun Biotech Co., Ltd, Hoffmann-La Roche, Prelude Therapeutics, Lava Therapeutics, and others.

Relapsed/Refractory Acute Myeloid Leukemia Pipeline Analysis:

The Relapsed/Refractory Acute Myeloid Leukemia pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Relapsed/Refractory Acute Myeloid Leukemia with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Relapsed/Refractory Acute Myeloid Leukemia Treatment.

• Relapsed/Refractory Acute Myeloid Leukemia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Relapsed/Refractory Acute Myeloid Leukemia 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.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Relapsed/Refractory Acute Myeloid Leukemia 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 Relapsed/Refractory Acute Myeloid Leukemia drugs and therapies

Relapsed/Refractory Acute Myeloid Leukemia Pipeline Market Drivers

• Rising incidence of Acute Myeloid Leukemia, advancements in pharmacology and molecular biology to promote drug development, rising geriatric population are some of the important factors that are fueling the Relapsed/Refractory Acute Myeloid Leukemia Market.

Relapsed/Refractory Acute Myeloid Leukemia Pipeline Market Barriers

• However, high cost associated with the management of AML, side effects associated with the AML treatment and other factors are creating obstacles in the Relapsed/Refractory Acute Myeloid Leukemia Market growth.

Scope of Relapsed/Refractory Acute Myeloid Leukemia Pipeline Drug Insight

• Coverage: Global

• Key Relapsed/Refractory Acute Myeloid Leukemia Companies: Cellectis, Foghorn Therapeutics, AB Science, Oncoceutics, Sanofi, TC Biopharm, Merck & Co, GlycoMimetics, AROG Pharmaceuticals, and others

• Key Relapsed/Refractory Acute Myeloid Leukemia Therapies: UCART 123, FHD-286, AB8939, ONC201, Sarclisa, TCB008, Keytruda, Uproleselan, Crenolanib, and others

• Relapsed/Refractory Acute Myeloid Leukemia Therapeutic Assessment: Relapsed/Refractory Acute Myeloid Leukemia current marketed and Relapsed/Refractory Acute Myeloid Leukemia emerging therapies

• Relapsed/Refractory Acute Myeloid Leukemia Market Dynamics: Relapsed/Refractory Acute Myeloid Leukemia market drivers and Relapsed/Refractory Acute Myeloid Leukemia market barriers

Request for Sample PDF Report for Relapsed/Refractory Acute Myeloid Leukemia Pipeline Assessment and clinical trials

Table of Contents

1. Relapsed/Refractory Acute Myeloid Leukemia Report Introduction

2. Relapsed/Refractory Acute Myeloid Leukemia Executive Summary

3. Relapsed/Refractory Acute Myeloid Leukemia Overview

4. Relapsed/Refractory Acute Myeloid Leukemia- Analytical Perspective In-depth Commercial Assessment

5. Relapsed/Refractory Acute Myeloid Leukemia Pipeline Therapeutics

6. Relapsed/Refractory Acute Myeloid Leukemia Late Stage Products (Phase II/III)

7. Relapsed/Refractory Acute Myeloid Leukemia Mid Stage Products (Phase II)

8. Relapsed/Refractory Acute Myeloid Leukemia Early Stage Products (Phase I)

9. Relapsed/Refractory Acute Myeloid Leukemia Preclinical Stage Products

10. Relapsed/Refractory Acute Myeloid Leukemia Therapeutics Assessment

11. Relapsed/Refractory Acute Myeloid Leukemia Inactive Products

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

13. Relapsed/Refractory Acute Myeloid Leukemia Key Companies

14. Relapsed/Refractory Acute Myeloid Leukemia Key Products

15. Relapsed/Refractory Acute Myeloid Leukemia Unmet Needs

16 . Relapsed/Refractory Acute Myeloid Leukemia Market Drivers and Barriers

17. Relapsed/Refractory Acute Myeloid Leukemia Future Perspectives and Conclusion

18. Relapsed/Refractory Acute Myeloid Leukemia 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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