Lindsey Shapiro, PhD,  science writer—

Cartesian Therapeutics has aligned with the U.S. Food and Drug Administration (FDA) on the design of the planned Phase 3 AURORA trial that will test its investigational cell therapy Descartes-08 in people with myasthenia gravis (MG). The FDA, under its special protocol assessment process, provided written agreement…

The investigational cell therapy Descartes-08 led to durable reductions in disease severity for people with myasthenia gravis (MG), according to updated Phase 2b trial results presented by Cartesian Therapeutics, its developer. “Data reported today add to the growing body of evidence supporting the potential for Descartes-08 to provide…

HNSA-5487, an investigational therapy being developed for potential use in myasthenia gravis (MG) and other autoimmune diseases, was safe and rapidly lowered the levels of immunoglobulin G (IgG) antibodies in the bloodstream, according to data from a Phase 1 clinical trial. IgGs are a class of antibodies found in…

ARGX-119, an antibody designed to increase the activity of the muscle-specific kinase (MuSK) protein, protected against the development of neuromuscular disease in mice in a model of MuSK-associated myasthenia gravis (MG), and eased or reversed evident symptoms in animals with disease onset, scientists report. With further work, such an…

Johnson & Johnson has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of nipocalimab to treat people with generalized myasthenia gravis (gMG). The application covers gMG patients who are positive for disease-causing antibodies against acetylcholine receptors (AChRs), muscle-specific kinase (MuSK), and low…

By March, Immunovant plans to initiate four or five pivotal clinical trials of its lead therapeutic candidate IMVT-1402 across a range of autoimmune conditions, including myasthenia gravis (MG). Pivotal, or registrational, trials are large-scale studies whose data could support regulatory applications seeking a therapy’s approval. Immunovant announced…

Treatment with the investigational CAR T-cell therapy Descartes-08 led to deep and sustained reductions in disease severity among generalized myasthenia gravis (gMG) patients, according to top-line data from a Phase 2b clinical trial. The therapy, designed somewhat differently than others in its class, also avoided some of the potentially…

Immunovant plans to prioritize development of its newer treatment candidate, IMVT-1402, over its Phase 3 candidate, batoclimab, for people with myasthenia gravis (MG), with tentative plans to launch a registrational clinical trial program of IMVT-1402 within the next year. Registrational studies are those that can back a…

Cartesian Therapeutics’ investigational cell therapy Descartes-08 has been granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of myasthenia gravis (MG). RMAT status is intended for experimental regenerative medicines to treat, modify, reverse, or cure a serious or life-threatening…

No significant differences in clinical outcomes or quality of life were observed between myasthenia gravis (MG) patients treated with azathioprine or mycophenolate mofetil (MMF), results from the PROMISE-MG observational study show. While “more comparative effectiveness studies are required,” the findings “provide important information for the clinical management…