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(Albany, US) September 27, 2026- DelveInsight’s, “Myositis Pipeline Insight 2026” report provides comprehensive insights about 40+ companies and 45+ pipeline drugs in Myositis pipeline landscape. It covers the Myositis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Myositis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Myositis Pipeline @ https://www.delveinsight.com/sample-request/myositis-pipeline-insight

Key Takeaways from the Myositis Pipeline Report

• On September 24, 2026- AstraZeneca initiated a phase III study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.
• On September 21, 2026- Janssen Research & Development LLC conducted a phase 2 study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
• On September 21, 2026- argenx highlighted a phase 2/3 study’s purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS).
• On September 17, 2026- Cabaletta Bio announced a phase 1/2 study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
• On September 15, 2026- Priovant Therapeutics Inc. initiated a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.
• On September 15, 2026- Pfizer conducted a phase 3 study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.
• DelveInsight’s Myositis Pipeline report depicts a robust space with 40+ active players working to develop 45+ pipeline therapies for Myositis treatment.
• The leading Myositis Companies such as Pfizer, Galapagos NV, Fate Therapeutics, Artiva Biotherapeutics, Inc., Aavogen, CRISPR Therapeutics, Century Therapeutics, Inc., Cabaletta Bio, Miltenyi Biotec GmbH, Nkarta, Inc., Kyverna Therapeutics, Gilead Sciences, Bristol-Myers Squibb, Allogene Therapeutics, Adicet Therapeutics and others.
• Promising Myositis Pipeline Therapies such as HuABC2, PF1801, PN-101, M5049, Descartes-08, Ophthalmic Emulsion, Emapalumab, GB-0998 and others.

Get insights into Myositis Clinical Trials, emerging therapies, and leading companies with DelveInsight @ Myositis Treatment Drugs

Myositis Overview

Myositis is a group of rare inflammatory muscle diseases characterized by muscle inflammation, weakness, fatigue, and, in some cases, skin or other systemic manifestations. It can affect individuals across different age groups and may include conditions such as dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, and inclusion body myositis. Diagnosis typically involves clinical evaluation, muscle enzyme testing, autoantibody assessments, imaging, electromyography, and muscle biopsy when required. Treatment approaches vary according to the specific type and severity of myositis and may include corticosteroids, immunosuppressive therapies, immunomodulators, and supportive rehabilitation.

Myositis Emerging Drugs Profile

• PF-06823859: Pfizer

PF-06823859 is a humanized monoclonal antibody developed by Pfizer that targets interferon-beta, aiming to inhibit key inflammatory signaling pathways involved in idiopathic inflammatory myopathies. By reducing immune-mediated inflammation in muscle and skin tissues, it is designed to improve muscle strength and decrease disease activity in conditions such as dermatomyositis and polymyositis. This therapy represents a targeted approach to modulating cytokine-driven disease mechanisms. PF-06823859 is currently under evaluation in Phase III clinical trials for the treatment of myositis.

• GLPG3667: Galapagos NV

GLPG3667 is an investigational, oral small-molecule TYK2 (tyrosine kinase 2) inhibitor developed by Galapagos, designed to selectively modulate key cytokine signaling pathways involved in autoimmune diseases. By inhibiting TYK2, it blocks downstream signaling of cytokines such as type I interferons, IL-12, and IL-23, thereby reducing immune-mediated inflammation in idiopathic inflammatory myopathies. In myositis, including dermatomyositis and polymyositis, this mechanism may help improve muscle strength, control skin manifestations, and decrease overall disease activity. The drug is currently in Phase II stage of its development for the treatment of myositis.

• FT819: Fate Therapeutics

FT819 is an investigational, off-the-shelf allogeneic CAR T-cell therapy engineered to target CD19-positive B cells, developed using induced pluripotent stem cell (iPSC) technology. By selectively depleting pathogenic B cells, it aims to reduce autoantibody production and modulate aberrant immune responses involved in idiopathic inflammatory myopathies. In myositis, particularly autoantibody-driven subtypes, this approach may help decrease disease activity and improve muscle function. FT819 is currently in Phase I stage of its development.

The Myositis Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Myositis 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 Myositis Treatment.
• Myositis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Myositis 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 Myositis market

Explore groundbreaking therapies and clinical trials in the Myositis Marketed and Pipeline Drugs @ New Myositis Drugs

Myositis Companies

Pfizer, Galapagos NV, Fate Therapeutics, Artiva Biotherapeutics, Inc., Aavogen, CRISPR Therapeutics, Century Therapeutics, Inc., Cabaletta Bio, Miltenyi Biotec GmbH, Nkarta, Inc., Kyverna Therapeutics, Gilead Sciences, Bristol-Myers Squibb, Allogene Therapeutics, Adicet Therapeutics and others.

Myositis 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Myositis Products have been categorized under various Molecule types such as

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

Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Myositis Market Drivers and Barriers

Scope of the Myositis Pipeline Report

• Coverage- Global
• Myositis Companies- Pfizer, Galapagos NV, Fate Therapeutics, Artiva Biotherapeutics, Inc., Aavogen, CRISPR Therapeutics, Century Therapeutics, Inc., Cabaletta Bio, Miltenyi Biotec GmbH, Nkarta, Inc., Kyverna Therapeutics, Gilead Sciences, Bristol-Myers Squibb, Allogene Therapeutics, Adicet Therapeutics and others.
• Promising Myositis Pipeline Therapies- HuABC2, PF1801, PN-101, M5049, Descartes-08, Ophthalmic Emulsion, Emapalumab, GB-0998 and others
• Myositis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Myositis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight’s in-depth Myositis Pipeline report today! @ Myositis Companies, Key Products and Unmet Needs

Table of Content

1. Introduction
2. Executive Summary
3. Myositis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Myositis – DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. PF-06823859: Pfizer
9. Mid-Stage Products (Phase II/III)
10. GLPG3667: Galapagos NV
11. Drug profiles in the detailed report…..
12. Early Stage Products (Phase I)
13. FT819: Fate Therapeutics
14. Drug profiles in the detailed report…..
15. Pre-clinical and Discovery Stage Products
16. Inactive Products
17. Myositis Key Companies
18. Myositis Key Products
19. Myositis Unmet Needs
20. Myositis Market Drivers and Barriers
21. Myositis Future Perspectives and Conclusion
22. Myositis Analyst Views
23. Myositis Key Companies
24. Appendix

About Us

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