The Myasthenia Gravis 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.

“Myasthenia Gravis Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Myasthenia Gravis Market.

Some of the key takeaways from the Myasthenia Gravis Pipeline Report:

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

• Myasthenia Gravis companies working in the treatment market are Alpine Immune Science, Toleranzia, Cabaletta Bio, Rallybio, Alexion Pharmaceuticals, Takeda, Cartesian Therapeutics, RemeGen, Horizon Therapeutics, and others, are developing therapies for the Myasthenia Gravis treatment

• Emerging Myasthenia Gravis therapies in the different phases of clinical trials are- Povetacicept, TOL 2, MuSK-CAART, RLYB116, ALXN2050, TAK-079, Descartes-08, Telitacicept, Inebilizumab, and others are expected to have a significant impact on the Myasthenia Gravis market in the coming years.

• In May 2025, The FDA approved a new therapy for generalized myasthenia gravis (gMG), a condition characterized by severe muscle weakness, rapid fatigue, and challenges with speech and swallowing. This new treatment, called nipocalimab and marketed as Imaavy, provides a long-lasting option for symptom management, benefiting approximately 100,000 people affected by gMG in the U.S. It is the first and only therapy designed to address the underlying cause of the disease in adults and adolescents aged 12 and older who possess specific antibodies associated with gMG.

• In April 2025, Nipocalimab-aahu is a human IgG1 monoclonal antibody designed to target the neonatal Fc receptor (FcRn) with high affinity, thereby reducing circulating IgG levels. Its approval was supported by results from the Phase 3 Vivacity-MG3 trial (ClinicalTrials.gov ID: NCT04951622), a randomized, double-blind, placebo-controlled study. The trial involved adult patients with generalized myasthenia gravis (gMG), classified as class II to IV by the Myasthenia Gravis Foundation of America, who had an inadequate response to standard therapies, indicated by an MG-ADL score of 6 or above.

• In April 2025, Promising results from the Phase 3 clinical trial (NCT05737160) assessing the safety and efficacy of Telitacicept (RC18; brand name: 泰爱®) in patients with generalized myasthenia gravis (gMG) were shared during the Late-Breaking Science Session at the 2025 American Academy of Neurology (AAN) Annual Meeting.

• In April 2025, Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotech company focused on developing cell therapies for autoimmune disorders, has reported 12-month efficacy and safety results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). Patients who received a single six-week treatment course of Descartes-08 showed sustained improvement in MG symptoms, which persisted through the 12-month follow-up evaluation.

• In March 2025, Immunovant decided not to pursue regulatory approval for its myasthenia gravis (MG) treatment, batoclimab, despite the Phase III study meeting its primary endpoint of reducing disease symptoms. Instead, the company will leverage the data to further develop its alternative therapy, IMVT-1402. The Phase III randomized trial (NCT05403541) assessed the impact of weekly or bi-monthly doses of batoclimab on acetylcholine receptor antibody-positive (AChR+) patients, using the Myasthenia Gravis Activities of Daily Living (MG-ADL) score over a 12-week period.

• In December 2024, Cartesian Therapeutics revealed updated efficacy and safety data from the Phase IIb trial of its mRNA cell therapy candidate, Descartes-08, for generalized myasthenia gravis (MG). The results showed sustained responses at the 12-month mark. The double-blind, placebo-controlled, crossover trial (NCT06038474) was open-label and involved 36 heavily pre-treated, symptomatic patients. Half of the participants received a placebo, while the other half were treated with Descartes-08, both administered as six weekly outpatient infusions without prior chemotherapy preconditioning.

Myasthenia Gravis Overview

Myasthenia Gravis is a chronic autoimmune neuromuscular disorder characterized by weakness and rapid fatigue of voluntary muscles. The name, which translates to “grave muscle weakness,” reflects the primary symptom of the condition. Myasthenia Gravis occurs when the immune system produces antibodies that interfere with the communication between nerves and muscles.

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Emerging Myasthenia Gravis Drugs Under Different Phases of Clinical Development Include:

• Povetacicept: Alpine Immune Science

• TOL 2: Toleranzia

• MuSK-CAART: Cabaletta Bio

• RLYB116: Rallybio

• ALXN2050: Alexion Pharmaceuticals

• TAK-079: Takeda

• Descartes-08: Cartesian Therapeutics

• Telitacicept: RemeGen

• Inebilizumab: Horizon Therapeutics

Myasthenia Gravis 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

• Infusion

• Intradermal

• Intramuscular

• Intranasal

• Oral

• Parenteral

• Subcutaneous

• Topical

• Molecule Type

Myasthenia Gravis Molecule Type

Myasthenia Gravis Products have been categorized under various Molecule types, such as

• Vaccines

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Product Type

Myasthenia Gravis Pipeline Therapeutics Assessment

• Myasthenia Gravis Assessment by Product Type

• Myasthenia Gravis By Stage and Product Type

• Myasthenia Gravis Assessment by Route of Administration

• Myasthenia Gravis By Stage and Route of Administration

• Myasthenia Gravis Assessment by Molecule Type

• Myasthenia Gravis by Stage and Molecule Type

DelveInsight’s Myasthenia Gravis 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)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Myasthenia Gravis product details are provided in the report. Download the Myasthenia Gravis pipeline report to learn more about the emerging Myasthenia Gravis therapies

Some of the key companies in the Myasthenia Gravis Therapeutics Market include:

Key companies developing therapies for Myasthenia Gravis are – CuraVac, Grifols SA, Immunovant, Mitsubishi Tanabe Pharma, Novartis, Alexion Pharmaceutical, Argenx, Astellas Pharma, UCB Pharma, Bausch Health, and others.

Myasthenia Gravis Pipeline Analysis:

The Myasthenia Gravis pipeline report provides insights into

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

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

• Myasthenia Gravis 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 Myasthenia Gravis 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.

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Myasthenia Gravis Pipeline Market Drivers

• Increasing prevalence of Myasthenis gravis, growing awareness regarding the myasthenia gravis diagnosis options, surge in geriatric population with autoimmune disease are some of the important factors that are fueling the Myasthenia Gravis Market.

Myasthenia Gravis Pipeline Market Barriers

• However, limited reimbursement policies, high cost associated with the treatment and other factors are creating obstacles in the Myasthenia Gravis Market growth.

Scope of Myasthenia Gravis Pipeline Drug Insight

• Coverage: Global

• Key Myasthenia Gravis Companies: Alpine Immune Science, Toleranzia, Cabaletta Bio, Rallybio, Alexion Pharmaceuticals, Takeda, Cartesian Therapeutics, RemeGen, Horizon Therapeutics, and others

• Key Myasthenia Gravis Therapies: Povetacicept, TOL 2, MuSK-CAART, RLYB116, ALXN2050, TAK-079, Descartes-08, Telitacicept, Inebilizumab, and others

• Myasthenia Gravis Therapeutic Assessment: Myasthenia Gravis current marketed and Myasthenia Gravis emerging therapies

• Myasthenia Gravis Market Dynamics: Myasthenia Gravis market drivers and Myasthenia Gravis market barriers

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Table of Contents

1. Myasthenia Gravis Report Introduction

2. Myasthenia Gravis Executive Summary

3. Myasthenia Gravis Overview

4. Myasthenia Gravis- Analytical Perspective In-depth Commercial Assessment

5. Myasthenia Gravis Pipeline Therapeutics

6. Myasthenia Gravis Late Stage Products (Phase II/III)

7. Myasthenia Gravis Mid Stage Products (Phase II)

8. Myasthenia Gravis Early Stage Products (Phase I)

9. Myasthenia Gravis Preclinical Stage Products

10. Myasthenia Gravis Therapeutics Assessment

11. Myasthenia Gravis Inactive Products

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

13. Myasthenia Gravis Key Companies

14. Myasthenia Gravis Key Products

15. Myasthenia Gravis Unmet Needs

16 . Myasthenia Gravis Market Drivers and Barriers

17. Myasthenia Gravis Future Perspectives and Conclusion

18. Myasthenia Gravis 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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