Primary Myelofibrosis Pipeline 2026: Therapies Under Investigation, Clinical Trials Milestones, And FDA Approvals By Delveinsight Galecto Biotech, Lynk Pharma, Samus Therapeutics, Taiga Biotech

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Primary Myelofibrosis pipeline constitutes 55+ key companies continuously working towards developing 55+ Primary Myelofibrosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Primary Myelofibrosis 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.

“Primary Myelofibrosis Pipeline Insight, 2026" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Primary Myelofibrosis Market.

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Some of the key takeaways from the Primary Myelofibrosis Pipeline Report:

• Companies across the globe are diligently working toward developing novel Primary Myelofibrosis treatment therapies with a considerable amount of success over the years.

• Primary Myelofibrosis companies working in the treatment market are Lynk Pharmaceuticals, Samus Therapeutics, Taiga Biotechnologies, Bristol-Myers Squibb, Sumitomo Pharma Oncology, Inc., Keros Therapeutics, Inc., Galecto Biotech AB, Actuate Therapeutics Inc., Karyopharm Therapeutics, AbbVie, Sierra Oncology, and others, are developing therapies for the Primary Myelofibrosis treatment

• Emerging Primary Myelofibrosis therapies in the different phases of clinical trials are- LNK01002, PU-H-71, TBX-2400, BMS-986158, TP-3654, KER-050, GB2064, 9-ING-41, Selinexor, Navitoclax, Momelotinib, and others are expected to have a significant impact on the Primary Myelofibrosis market in the coming years.

• In March 2026, Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company focused on developing innovative cancer therapies, announced topline results from its Phase 3 SENTRY trial. This randomized, double-blind, placebo-controlled study evaluated 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (n=353). The trial successfully met its first co-primary endpoint, showing a statistically significant improvement in spleen volume reduction of 35% or more (SVR35) among patients receiving the selinexor and ruxolitinib combination. The combination arm demonstrated rapid, deep, and sustained reductions in spleen volume.

• In March 2026, China's National Medical Products Administration (NMPA) approved Sino Biopharmaceutical Ltd. 's rovadicitinib, marketed as Anxu, for use as a first-line treatment in adult patients with intermediate- or high-risk primary myelofibrosis. This includes individuals with post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis.

• In February 2026, Prelude Therapeutics announced that its Phase 1 trial of PRT12396 is an open-label, multi-center study designed to evaluate safety and efficacy in patients with high-risk polycythemia vera (PV) as well as intermediate- and high-risk myelofibrosis (MF). The study's primary endpoints include safety, efficacy, and pharmacokinetic (PK) profile.

• In January 2026, Cellenkos® Inc., a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf regulatory T cell (Treg) therapies for autoimmune and inflammatory conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational candidate, CK0804, for the treatment of myelofibrosis. This rare blood cancer has an annual incidence of approximately 1–3 cases per 100,000 individuals and an estimated prevalence of around 25,000 patients in the United States.

• In September 2025, Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company specializing in innovative cancer treatments, announced that it has finished enrolling patients in the Phase 3 SENTRY trial. The study is assessing selinexor combined with ruxolitinib in JAK inhibitors–naïve patients with myelofibrosis.

• In July 2025, Incyte reported that Phase I clinical data evaluating its investigational therapy as monotherapy and in combination with ruxolitinib in myelofibrosis patients are expected in the latter half of 2025.

• In November 2024, MorphoSys announced favorable topline results from the Phase III MANIFEST-2 clinical trial evaluating pelabresib for myelofibrosis. The trial assessed pelabresib in combination with Jakafi (ruxolitinib) from Novartis and Incyte, compared to a placebo plus Jakafi, in JAK inhibitor-naïve patients with myelofibrosis.

• In October 2024, Ajax Therapeutics, Inc., a biopharmaceutical company focused on developing next-generation JAK inhibitors for myeloproliferative neoplasms (MPNs), has announced that the first patient has been dosed in its Phase 1 clinical trial of AJ1‐11095, a novel Type II JAK2 inhibitor, for the treatment of myelofibrosis.

Primary Myelofibrosis Overview

Primary Myelofibrosis (PMF) is a rare type of blood cancer classified under myeloproliferative neoplasms. It is characterized by the abnormal proliferation of bone marrow stem cells, leading to fibrosis (scarring) of the bone marrow, which impairs normal blood cell production.

As the disease progresses, the body compensates by producing blood cells in other organs, especially the spleen, causing splenomegaly (enlarged spleen). Common symptoms include fatigue, anemia, weakness, weight loss, night sweats, and bone pain.

Explore the latest Primary Myelofibrosis pipeline insights 2026, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Primary Myelofibrosis Clinical Trials

Emerging Primary Myelofibrosis Drugs Under Different Phases of Clinical Development Include:

• JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis

• INREBIC (fedratinib): Bristol Myers Squibb

• XPOVIO (selinexor): Karyopharm Therapeutics

• RYTELO (imetelstat): Geron Corporation

• REBLOZYL (luspatercept/ACE-536): Bristol Myers Squibb

• Navtemadlin (KRT-232): Kartos Therapeutics

• Pelabresib (DAK539): Novartis

• Bomedemstat (IMG-7289/MK-3543): Merck

• TL-895: Telios Pharma

• RVU120 ( SEL-120): Ryvu Therapeutics

• TP-3654 (nuvisertib): Syntara

• DISC-0974: Disc Medicine

• ELZONRIS (tagraxofusp/SL-401): Menarini Group

Primary Myelofibrosis Route of Administration

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

• Oral

• Parenteral

• Intravitreal

• Subretinal

• Topical

• Molecule Type

Primary Myelofibrosis Molecule Type

Primary Myelofibrosis Products have been categorized under various Molecule types, such as

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

• Product Type

Primary Myelofibrosis Pipeline Therapeutics Assessment

• Primary Myelofibrosis Assessment by Product Type

• Primary Myelofibrosis By Stage and Product Type

• Primary Myelofibrosis Assessment by Route of Administration

• Primary Myelofibrosis By Stage and Route of Administration

• Primary Myelofibrosis Assessment by Molecule Type

• Primary Myelofibrosis by Stage and Molecule Type

DelveInsight's Primary Myelofibrosis Report covers around 55+ products under different phases of clinical development like

• 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 Primary Myelofibrosis product details are provided in the report. Download the Primary Myelofibrosis pipeline report to learn more about the emerging Primary Myelofibrosis therapies

Some of the key companies in the Primary Myelofibrosis Therapeutics Market include:

Key companies developing therapies for Primary Myelofibrosis are - Pharmaxis, Keros Therapeutics, Bristol-Myers Squibb, Ascentage Pharma Group Inc., Sumitomo Pharma Oncology, Galecto Biotech AB, Actuate Therapeutics Inc, Karyopharm Therapeutics Inc, AbbVie, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Taiga Biotechnologies, Inc., Rigel Pharmaceuticals, Celgene, Novartis Pharmaceuticals, Sierra Oncology, Inc., Incyte Corporation, Imago BioSciences, Inc., Samus Therapeutics, Inc., and others.

Primary Myelofibrosis Pipeline Analysis:

The Primary Myelofibrosis pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Primary Myelofibrosis 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 Primary Myelofibrosis Treatment.

• Primary Myelofibrosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Primary Myelofibrosis 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 Primary Myelofibrosis 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 Primary Myelofibrosis drugs and therapies

Primary Myelofibrosis Pipeline Market Drivers

• Increase in R&D for the development of new and effective drug for the treatment. Increasing Incidence in Elderly Population, development of biological therapies or immunotherapies are some of the important factors that are fueling the Primary Myelofibrosis Market.

Primary Myelofibrosis Pipeline Market Barriers

• However, side effects associated with the drugs, high cost of therapy and other factors are creating obstacles in the Primary Myelofibrosis Market growth.

Scope of Primary Myelofibrosis Pipeline Drug Insight

• Coverage: Global

• Key Primary Myelofibrosis Companies: Lynk Pharmaceuticals, Samus Therapeutics, Taiga Biotechnologies, Bristol-Myers Squibb, Sumitomo Pharma Oncology, Inc., Keros Therapeutics, Inc., Galecto Biotech AB, Actuate Therapeutics Inc., Karyopharm Therapeutics, AbbVie, Sierra Oncology, and others

• Key Primary Myelofibrosis Therapies: LNK01002, PU-H-71, TBX-2400, BMS-986158, TP-3654, KER-050, GB2064, 9-ING-41, Selinexor, Navitoclax, Momelotinib, and others

• Primary Myelofibrosis Therapeutic Assessment: Primary Myelofibrosis current marketed and Primary Myelofibrosis emerging therapies

• Primary Myelofibrosis Market Dynamics: Primary Myelofibrosis market drivers and Primary Myelofibrosis market barriers

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Table of Contents

1. Primary Myelofibrosis Report Introduction

2. Primary Myelofibrosis Executive Summary

3. Primary Myelofibrosis Overview

4. Primary Myelofibrosis- Analytical Perspective In-depth Commercial Assessment

5. Primary Myelofibrosis Pipeline Therapeutics

6. Primary Myelofibrosis Late Stage Products (Phase II/III)

7. Primary Myelofibrosis Mid Stage Products (Phase II)

8. Primary Myelofibrosis Early Stage Products (Phase I)

9. Primary Myelofibrosis Preclinical Stage Products

10. Primary Myelofibrosis Therapeutics Assessment

11. Primary Myelofibrosis Inactive Products

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

13. Primary Myelofibrosis Key Companies

14. Primary Myelofibrosis Key Products

15. Primary Myelofibrosis Unmet Needs

16. Primary Myelofibrosis Market Drivers and Barriers

17. Primary Myelofibrosis Future Perspectives and Conclusion

18. Primary Myelofibrosis 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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