Press release
Myositis Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight
Myositis Clinical Trials
(Albany, United States) "Myositis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Myositis Market.
As per DelveInsight's assessment, globally, Myositis pipeline constitutes 18+ key companies continuously working towards developing 20+ Myositis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.
The Myositis 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.
Request for sample report @ Myositis Pipeline Insight [https://www.delveinsight.com/sample-request/myositis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]
Some of the key takeaways from the Myositis Pipeline Report:
* Myositis Companies across the globe are diligently working toward developing novel Myositis treatment therapies with a considerable amount of success over the years.
* Myositis companies working in the treatment market are JN Biosciences, ImmunoForge, Paean Biotechnology Inc., Merck KGaA, and others, are developing therapies for the Myositis treatment
* Emerging Myositis therapies in the different phases of clinical trials are- HuABC2, PF1801, PN-101, M5049, and others are expected to have a significant impact on the Myositis market in the coming years.
* In June 2025, argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of positive results from Phase 2 studies evaluating VYVGART Registered (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025, from June 11 - 14 in Barcelona, Spain.
* In May 2025, Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration (FDA) meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel (resecabtagene autoleucel, formerly known as CABA-201).
* In March 2025, Abcuro, Inc., a clinical-stage biotech firm focused on treating autoimmune diseases and cancer by precisely targeting cytotoxic T cells, announced it will present safety, pharmacokinetic, and pharmacodynamic findings from its Phase 1 clinical trial of ulviprubart (ABC008) for inclusion body myositis (IBM) at the upcoming American Academy of Neurology (AAN) Annual Meeting.
* In February 2025, Abcuro secured $200 million in Series C funding to advance the development of its first-in-class therapy for inclusion body myositis. The funding will support the completion of the registrational Phase 2/3 MUSCLE trial evaluating ulviprubart, as well as the preparation for its Biologics License Application (BLA) submission and eventual commercial launch.
* In November 2024, argenx has chosen to advance the development of efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) in the ongoing Phase 2/3 ALKIVIA trial for adults with idiopathic inflammatory myopathies. This decision follows positive topline results from the Phase 2 segment, where the study met its primary endpoint by showing a statistically significant improvement in the mean total improvement score (TIS) at Week 24. Moreover, efgartigimod SC demonstrated favorable outcomes across all six core TIS measures compared to placebo.
Myositis Overview
Myositis is a rare inflammatory condition characterized by chronic muscle inflammation and weakness. Myositis primarily affects skeletal muscles, leading to progressive difficulty in performing daily activities. Myositis often involves other systems, causing complications such as Myositis-associated interstitial lung disease and Myositis-related cardiac issues. Myositis can be categorized into different subtypes, including Myositis polymyositis, Myositis dermatomyositis, Myositis inclusion body myositis, and Myositis necrotizing autoimmune myopathy, each with distinct clinical and pathological features.
Myositis diagnosis relies on a combination of Myositis-specific antibody testing, Myositis muscle biopsy, Myositis MRI imaging, and Myositis electromyography to confirm inflammation and muscle damage. Myositis treatment typically involves Myositis corticosteroids and immunosuppressants to reduce inflammation, along with Myositis physical therapy to improve muscle strength and function. Emerging Myositis biologic therapies and targeted agents are being explored to offer more effective management options.
Despite advancements, Myositis prognosis varies, with some patients achieving remission while others experience persistent disability. Myositis research continues to focus on understanding underlying autoimmune mechanisms and developing novel therapies to improve Myositis outcomes. Overall, early Myositis recognition and multidisciplinary care are essential to optimize quality of life and slow Myositis progression.
Get a Free Sample PDF Report to know more about Myositis Pipeline Therapeutic Assessment - Myositis Treatment Drugs [https://www.delveinsight.com/sample-request/myositis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]
Emerging Myositis Drugs Under Different Phases of Clinical Development Include:
* HuABC2: JN Biosciences
* PF1801: ImmunoForge
* PN-101: Paean Biotechnology Inc.
* M5049: Merck KGaA
Myositis Route of Administration
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
* Inhalation
* Inhalation/Intravenous/Oral
* Intranasal
* Intravenous
* Intravenous/ Subcutaneous
* NA
* Oral
* Oral/intranasal/subcutaneous
* Parenteral
* Subcutaneous
Myositis Molecule Type
Myositis Products have been categorized under various Molecule types, such as
* Antibody
* Antisense oligonucleotides
* Immunotherapy
* Monoclonal antibody
* Peptides
* Protein
* Recombinant protein
* Small molecule
* Stem Cell
* Vaccine
Myositis Pipeline Therapeutics Assessment
* Myositis Assessment by Product Type
* Myositis By Stage and Product Type
* Myositis Assessment by Route of Administration
* Myositis By Stage and Route of Administration
* Myositis Assessment by Molecule Type
* Myositis by Stage and Molecule Type
DelveInsight's Myositis Report covers around 20+ 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 Myositis product details are provided in the report. Download the Myositis pipeline report to learn more about the emerging Myositis therapies [https://www.delveinsight.com/sample-request/myositis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]
Some of the key companies in the Myositis Therapeutics Market include:
Key companies developing therapies for Myositis are - F. Hoffmann-La Roche Ltd, Pfizer Inc, Zydus Group, Lupin, Bausch Health Companies Inc., Accord Healthcare, Genentech, Inc, Johnson & Johnson Services, Inc., Novartis AG, Endo International Inc, Teva Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Ltd, Cipla Inc, Dr Reddy's Laboratories Ltd, Abbott, Bristol-Myers Squibb Company, GSK plc, Merz Pharma, Akorn, Incorporated, and others.
Myositis Pipeline Analysis:
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 key 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.
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 Myositis drugs and therapies [https://www.delveinsight.com/sample-request/myositis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]
Myositis Pipeline Market Drivers
* Growing cases of chronic muscle inflammation, continuous advancement in technology, increased injuries of muscle are some of the important factors that are fueling the Myositis Market.
Myositis Pipeline Market Barriers
* However, high cost of drugs, lack of approved therapies and other factors are creating obstacles in the Myositis Market growth.
Scope of Myositis Pipeline Drug Insight
* Coverage: Global
* Key Myositis Companies: JN Biosciences, ImmunoForge, Paean Biotechnology Inc., Merck KGaA, and others
* Key Myositis Therapies: HuABC2, PF1801, PN-101, M5049, and others
* Myositis Therapeutic Assessment: Myositis current marketed and Myositis emerging therapies
* Myositis Market Dynamics: Myositis market drivers and Myositis market barriers
Request for Sample PDF Report for Myositis Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/myositis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]
Table of Contents
1. Myositis Report Introduction
2. Myositis Executive Summary
3. Myositis Overview
4. Myositis- Analytical Perspective In-depth Commercial Assessment
5. Myositis Pipeline Therapeutics
6. Myositis Late Stage Products (Phase II/III)
7. Myositis Mid Stage Products (Phase II)
8. Myositis Early Stage Products (Phase I)
9. Myositis Preclinical Stage Products
10. Myositis Therapeutics Assessment
11. Myositis Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Myositis Key Companies
14. Myositis Key Products
15. Myositis Unmet Needs
16 . Myositis Market Drivers and Barriers
17. Myositis Future Perspectives and Conclusion
18. Myositis 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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