Myasthenia Gravis- Pipeline Insight, 2025

DelveInsight's, "Myasthenia Gravis- Pipeline Insight, 2025" report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Myasthenia Gravis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Myasthenia Gravis: Understanding

Myasthenia Gravis: Overview

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disorder characterized by muscle weakness and fatigue. In MG, the body's immune system mistakenly attacks receptors on muscle cells, preventing nerve impulses from properly communicating with muscles. This leads to weakness, particularly in muscles that control eye movements, facial expressions, chewing, swallowing, and speaking. However, it can also affect other muscles, including those involved in breathing and limb movements.

Signs and symptoms of myasthenia gravis can vary widely but often include drooping of one or both eyelids (ptosis), double vision (diplopia), difficulty speaking, chewing, or swallowing, weakness in the arms or legs, and fatigue that worsens with activity but improves with rest. Symptoms may worsen over the course of the day or after physical exertion.

The exact cause of myasthenia gravis is not fully understood, but it is believed to involve a combination of genetic, environmental, and immunological factors. Certain risk factors may increase the likelihood of developing MG, including being female (it's more common in women), having a family history of the condition, and having other autoimmune disorders like thyroid disease or lupus.

Diagnosing myasthenia gravis typically involves a thorough medical history, physical examination, and specialized tests such as electromyography (EMG), nerve conduction studies, blood tests to check for specific antibodies, and the edrophonium test, which involves injecting a medication to temporarily improve muscle strength. Treatment for myasthenia gravis aims to manage symptoms, improve muscle strength, and prevent complications. This may include medications to suppress the immune system's abnormal response (such as corticosteroids or immunosuppressants), medications that improve nerve-to-muscle communication (such as pyridostigmine), plasmapheresis to remove antibodies from the blood, intravenous immunoglobulin (IVIG) therapy, or, in some cases, surgery to remove the thymus gland (thymectomy). With proper treatment, many people with myasthenia gravis can lead relatively normal lives. However, ongoing management and monitoring are usually necessary to adjust treatment as needed and manage potential complications.

"Myasthenia Gravis- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Myasthenia Gravis pipeline landscape is provided which includes the disease overview and Myasthenia Gravis treatment guidelines. The assessment part of the report embraces, in depth Myasthenia Gravis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Myasthenia Gravis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Myasthenia Gravis R&D. The therapies under development are focused on novel approaches to treat/improve Myasthenia Gravis.

Myasthenia Gravis Emerging Drugs Chapters

This segment of the Myasthenia Gravis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Myasthenia Gravis Emerging Drugs

• HBM9161: Harbour BioMed (Guangzhou) Co. Ltd.

Batoclimab (HBM9161) is a novel, fully human anti-FcRn mAb blocking FcRn-IgG interactions and accelerating the degradation of autoantibodies. The product has the potential to address a variety of pathogenic IgG-mediated autoimmune diseases. Batoclimab is being evaluated for the treatment of patients with severe autoimmune diseases mediated by pathogenic immunoglobulin G (IgG), including generalized myasthenia gravis (gMG), thyroid eye disease (TED), neuromyelitis optica spectrum disorder (NMOSD) and immune thrombocytopenic purpura (ITP). Phase II study in generalized myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients' symptoms and improve quality of life. Completed studies demonstrated that batoclimab is well tolerated and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. Currently, the drug is in Preregistration stage of its development for the treatment of Myasthenia Gravis.

• KYV-101: Kyverna Therapeutics

KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. Kyverna is currently conducting trials of KYV-101 in patients with lupus nephritis, systemic sclerosis, and myasthenia gravis are in preparation. Currently, the drug is in Phase II stage of its development for the treatment of Myasthenia Gravis.

• CABA-201: Cabaletta Bio

CABA-201 is a fully human CD19 chimeric antigen receptor (CAR) T cell therapy containing a 4-1BB co-stimulatory domain. CABA-201 is designed to deeply and transiently deplete CD19-positive B cells following a one-time infusion, which may enable an "immune system reset" with the potential for durable remission off therapy in patients with autoimmune diseases. To date, Cabaletta has received clearance from the FDA for Investigational New Drug (IND) applications for CABA-201 in multiple autoimmune conditions including systemic lupus erythematosus (SLE), myositis, systemic sclerosis (SSc) and generalized myasthenia gravis (gMG). Cabaletta is conducting four RESET(TM) Phase I/II clinical trials with a total of nine cohorts that can advance simultaneously, employing a similar parallel cohort design and starting dose of 1 x 106 cells/kg without a dose escalation requirement. Currently, the drug is in Phase I/II stage of its development for the treatment of Myasthenia Gravis.

Myasthenia Gravis: Therapeutic Assessment

This segment of the report provides insights about the different Myasthenia Gravis drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Myasthenia Gravis
• There are approx. 20+ key companies which are developing the therapies for Myasthenia Gravis. The companies which have their Myasthenia Gravis drug candidates in the most advanced stage, i.e. Preregistration include, Harbour BioMed (Guangzhou) Co. Ltd.
• Phases

DelveInsight's report covers around 22+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Myasthenia Gravis 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
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Myasthenia Gravis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Myasthenia Gravis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Myasthenia Gravis drugs.

Myasthenia Gravis Report Insights

• Myasthenia Gravis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Myasthenia Gravis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Myasthenia Gravis drugs?
• How many Myasthenia Gravis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Myasthenia Gravis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Myasthenia Gravis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Myasthenia Gravis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Harbour BioMed (Guangzhou) Co. Ltd.
• Kyverna Therapeutics
• Cabaletta Bio
• Takeda
• Hoffmann-La Roche
• Immunovant Sciences GmbH
• Regeneron Pharmaceuticals
• Novartis Pharmaceuticals
• Janssen Research & Development, LLC
• Momenta Pharmaceuticals, Inc.
• Amgen
• Dianthus Therapeutics
• Cartesian Therapeutics
• COUR Pharmaceutical Development Company, Inc.
• Alexion Pharmaceuticals, Inc

Key Products

• HBM9161
• KYV-101
• CABA-201
• TAK-079
• Satralizumab
• RVT-1401
• Pozelimab
• CFZ533
• Nipocalimab
• M281
• Inebilizumab
• DNTH103
• Descartes-08
• CNP-106
• ALXN1720